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International Regulatory Affairs Focus-Deadly Enterovirus 71 in China

International Regulatory Affairs Focus: A new lethal virus in Bolivia

International Regulatory Affairs Focus: Fake Malaria Drugs

Distinguished Speakers Illuminate Clinical Trials Convention
Solomon K. Sackitey, International Regulatory Affairs Updates
14 April 2008

For the next couple of days, the Mandalay Bay Resort and Casino in Las Vegas, Nevada (USA) will take center-stage not for a World Heavyweight Boxing match but for heavyweights whose current thinking could have a major impact on the future of drugs, biologics and medical device design, clinical trials, regulations, labeling and pricing.

One of such speakers, Jethro Ekuta (DVM, PhD) of Nigeria, is an expert on Pediatric Drugs Development and Regulation. His presentation in the Pediatric Clinical Trials Symposium is captioned “Regulatory changes and requirements: we have the rules, now how do we play?”. His other speaking engagements on pediatric drugs development and clinical trials include the 2008 Regulatory Affairs Professionals Society (RAPS) Annual Conference where he will be making presentations on, Pediatric Drug Development, and Post-marketing Requirements for Drugs, Biologics and Medical Devices.

In Las Vegas, Dr. Ekuta will be addressing, among other subjects, the following questions:

- Where is the industry headed? How will regulations play out?

- How are the recent legislations going to play out from a drug development perspective?

- How do you incorporate the recent regulatory requirements into your clinical plans? How fine-tuned do your plans need to be?

- With the new laws in place, how do we work within the context of both the EU and US regulatory environments?

- If you are trying to develop pediatric programs that work, what are the critical elements of strategy for a global pediatric program?

- What role do regulators (i.e. FDA, EMEA) have in enhancing global pediatric development?

Other speakers include Earvin ’Magic’ Johnson, a former basketball player of the Los Angeles Lakers and a 2002 Basketball Hall of Fame inductee who will be making a speech during the 17th Annual Partnerships with CROs meeting.

As a prelude to the 17th Annual Partnerships with CROs Conference, the Institute for International Research and other organizations have scheduled a number of symposia and workshops beginning today.

These include the Pediatric Clinical Trials Symposium, the12th Annual Electronic Data Capture (EDC) Pre-conference Workshop, the 5th Annual Project Management for Drugs and Device and the Vaccines Development Forum.

Per scheduled agenda, the Las Vegas Convention will seek to address the following in addition to other contemporary issues:

Pediatric Exclusivity Trials: lessons learned from the field

Patient Recruitment and Retention Strategies

Trial Design Considerations

Practical and Ethical Considerations to Expedite Your Drugs to Market

Advancing the Discipline of Managing Clinical Trial Data Using EDC

The Top Ten Challenges Cited By Scientists in Vaccines Development

Powering Up For the Challenge: Innovation, Consolidation and Globalization in Drug Development Partnerships

Innovative Enterprise: Global Sourcing and Pharmacovigilance—Establishing Collaborative Partnerships to Enhance Efficiency, Flexibility and Patient Safety

In view of the global nature of these presentations, at the end of this year’s conference, the meetings are expected to be of immense value to the global health market in general, more so, when Emerging Markets are gaining significant attention in a global economy.

A recent report by IMS Health indicates that emerging markets will be a major force to recon with in the pharmaceutical industry where sales are projected to be in the neighborhood of $400 billion by the year 2020. This report points out a 12-13% growth per year in countries including China, India, Brazil, Russia, Mexico, South Korea and Turkey whilst single digit growth in the highly industrialized countries is projected.

The much neglected African market has been enjoying significant economic growth of late and is a potential fertile economic ground for outsourcing clinical research and pharmaceutical raw materials manufacturing ( see here for details).

In the Medical Device industry, while Global Harmonization Task Force (GHTF) founding members, US, EU, Japan, Canada, and Australia countries enjoy a formidable export values, a prominent competition from the emerging markets of the Pacific Rim, East Asia, the Middle East, and South America are imminent. The US export markets in the Medical Device industry, according to a recent study , have an 89 % share or $35 billion of the global $40 billion value.

International Regulatory Affairs Focus- Regulatory and Clinical Research Jobs
International Regulatory Affairs Updates now offer Jobs Services

International Regulatory Affairs Updates , the number one resource for International Regulatory Affairs information searches on Google and Yahoo search engines, now offers Jobs Services for Regulatory Affairs and Clinical Research job opportunities worldwide.

Regulatory Affairs jobs, Clinical Trials auditing, Clinical Trials monitoring relating to job opportunities in medical devices, human healthcare, animal healthcare, environmental health, biosafety regulations, traditional and herbal medicines, Clinical Research Associates (CRAs) job or career openings and biotechnology jobs are just a few of the areas you might consider for job advertisements in this global virtual Regulatory Affairs Library or community.

With this global outreach, you might want to consider advertising Regulatory Affairs, Medical Devices and Clinical Research jobs on the International Regulatory Affairs Updates website.

For advertising Drugs, Medical Devices, Biologics, Regulatory Affairs and Clinical Trials Research Job opportunities, please, contact us at: info@iraup.com for details.

International Regulatory Affairs Focus: New International Health Regulations

International Regulatory Affairs Focus: Malaria Day in the Americas

International Regulatory Affairs Focus- Global Regulatory Affairs

International Regulatory Affairs Focus: Pediatric Drug Development
African Clinical and Regulatory Scientists Speak on Pediatric Drugs Development .
29 November, 2007 by Solomon K. Sackitey

A renowned Nigerian Clinical and Regulatory Scientist, Jethro Ekuta , DVM, PhD, Group Director, Aggregate Safety Reporting in Global Pharmacovigilance and Epidemiology at pharmaceutical giant Bristol-Myers Squibb was one of several featured speakers at the 2007 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition at the San Diego Convention Center, San Diego, California which was held on 11-15 November, 2007.

At the same conference, another African, Henrietta Ukwu , M.D, a Senior Vice President of Worldwide Regulatory Affairs who is also a Professor, spoke on “Clinical and Regulatory Challenges in Pediatric Drug Development”.

Speaking on the topic “Regulatory Approaches for Extrapolating Data to the Pediatric Populations”, Dr. Ekuta directed attention to an apparent oversight involving the enrollment of children in clinical trials. Drug prescriptions for children, for the most part, have been based on estimates of adult drug dosage. This approach may be changing soon as Global Regulatory champions, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have made it a requirement now require that, drugs indicated for the pediatric population should have supporting clinical data from said population.

Dr. Ekuta was on a panel discussion which reviewed the current thinking of EU and US regulators with regards to Regulatory and Clinical Approaches, Challenges and the FDA’s experience in Pediatric Drug Development.

Additional coverage on pediatric drug development and regulation is available here .

International Regulatory Affairs Focus- Microbicides Safety

International Regulatory Affairs Focus: Microbicide Trials in Africa

International Regulatory Affairs Focus: Asian Microbicide Trials

International Regulatory Affairs Focus: Biosafety Framework in Ghana
NATIONAL BIOSAFETY FRAMEWORK FOR GHANA PUBLISHED

18 November, 2007. Posted by Solomon K. Sackitey. Source: Biotechnology and Nuclear Agriculture Research Institute (BNARI). For additional information, contact, f.apeabah@bnari.org

The framework’s editors, Alex Owusu-Biney, Eric. C. Quaye and Josephine Nketsia-Tabiri, announce the publication of Ghana’s National Biosafety Framework on the Biotechnology and Nuclear Agriculture Research Institute (BNARI) website earlier this month. Ghana is one of the few African countries to develop a national biosafety framework. “It is modeled after the UNEP/GEF blue print which includes:

A Government Policy on Biosafety

A Regulatory Regime

A System to handle requests for authorisations (including risk assessment, decision making) and administrative functions

Systems for “follow up” (such as enforcement and monitoring for environmental
effects)

Systems for Public Awareness and Participation

According to Prof Kasim Kasanga, Minister of The Environment and Science, “The Framework has evolved through the contribution of several ministries and stakeholders to ensure that the document is country owned. The next step is for its implementation and this calls for hard work and strong partnerships from all Ghanaians, the donor community, the private sector, the NGOs and the research fraternity in Ghana and the rest of the world”.

See the report for additional information highlighting the Ghana Government’s commitment to Biosafety Regulation in the country.

International Regulatory Affairs Focus: Clinical Trials Oversight
29 October, 2007. United States: FDA Oversight Of Clinical Trials. Article by Bernadette Broccolo, Jennifer S. Geetter, Robert B. Nicholas and Paul W. Radensky; 23 October 2007.

Office of the Inspector General issues recommendations on FDA investigation processes and regulations. The Report recommended five steps the FDA should take to improve its monitoring of clinical trials:

International Regulatory Affairs Focus: General Health and Nutrition
Ghana Floods Update; Posted: 21 September, 2007. SOURCE: United Nations / Nations Unies OFFICE FOR THE COORDINATION OF HUMANITARIAN AFFAIRS UNDAC SITUATION REPORT no.6. 21/09/2007; UNDAC Team Tamale;

Within the past few days, Ghana has been at the mercy of a natural phenomenum, floods. The need for health and nutrition relief efforts cannot be overemphasised. Below is a humanitarian contributions report towards the fulfilment of the Global Millennium Development Goal number 6: Combating HIV/AIDS, malaria and other diseases. To say the least, the flood in Northern Ghana is bound to worsen healthcare in the Region if prompt and adequate solutions are not provided.

• Summary
- Meetings have been conducted on national as well as regional level to discuss the outcome of the joint rapid assessments and how to ensure a fully coordinated approach to the relief operation.
- Today, the Government announced that the figures concerning the number of affected and the damage caused by the floods are crude and preliminary and need revising as the process with information gathering is proceeding.
- UNICEF has delivered relief items to the Regional Coordination Council for distribution in the affected areas.
- WFP is planning on distributing high energy biscuits throughout the affected regions during the weekend.


• General situation overview
- The NGO Concern Universal has conducted an assessment in the Upper West region. According to their assessment, more than 6,000 people are affected in this region. The immediate needs are food, safe drinking water and sanitary facilities. Also, a limited number of people are in need of shelter.
- According to national authorities in the Northern region, three main areas of concern has been identified in the region; Daboya, Saboba and Kpasemkpe.
- WFP is planning on delivering a total of approximately 16 tons of high energy biscuits to districts in the Upper East and Northern regions during the weekend. Depending on available helicopter resources, WFP is also looking into possibilities for air delivery of high energy biscuits to areas cut off by the floods.
- On Sunday, UNICEF is planning to conduct a WASH and health/nutrition assessment in the Upper West Region.


• Coordination overview
- Friday 21/9
 0900 Meeting in Accra between the Resident Coordinator and the UNCT to discuss, amongst other agenda items, a sectoral approach through identified priority areas. A Humanitarian Coordination Team (HCT) comprising UN agencies, the Red Cross Movement, NGOs and donors should take care of the operational aspect of the emergency response.
 0900 Meeting between the UNCT, UNDAC team and national authorities at the Regional Coordination Council in Tamale.
 1000 Meeting between Map Action, WFP officer responsible for mapping, NADMO and UNDAC team.
 1030 Meeting at the UNICEF premises in Tamale to follow up on Thursday’s meeting and continue discussions within the different sectors.
 1100 UNCT invited to the Ministry of Interior to discuss the results of the joint assessments and the way forward. It has been proposed to establish a “Who does What Where”database. This will be part of the information management plan to be established in partnership with the national authorities.
 A meeting between the National Coordinator, Dr. Dampare, and the UNDAC Team Leader, Josef Reiterer, is scheduled for tonight. A two-way information flow between the Government’s Operations Room and the established coordination mechanisms of the international community will be discussed.

- Monday 24/9
 0900 General coordination meeting at the Regional Coordination Council for all actors involved in the relief operation. The aim of the meeting is to agree on a fully integrated and coordinated approach to the relief operation in the Northern Region.

- Tuesday 25/9
 1600 WASH sector meeting at the UNICEF premises.

- The aim of today’s meeting at the Regional Coordination Council in Tamale was to establish contact with the regional authorities so that effective coordination and planning can be conducted for the relief operation as well as identifying the logistical gaps. Furthermore, the way forward following the joint assessment mission was discussed.
- In order to facilitate coordination, the UNDAC team has initiated the establishment of a matrix of actors and activities in order to get an overview as well as identifying gaps and potential areas of duplication. Today’s humanitarian coordination meeting at the UNICEF premises in Tamale focused on identifying the activities of the different actors as well as discussing sectorial responsibilities.
- It is planned to look into possibilities for coordination meetings with regional authorities in the Upper West and Upper East regions.
- WFP is bringing in an emergency coordinator who will chair the food security sector.


• Operational considerations
- At today’s meeting with national authorities of the Northern region it was indicated that the delivery of relief items in the region was hampered due to lack of good trucks. They also stated that finding the resources to organise the loading and off-loading of trucks delivering aid is a challenge.
- Also, the lack of up-dated maps was discussed, which resulted in Map Action agreeing to produce several maps for the Regional Coordination Council.
- The UNDAC team is providing facilitation for sectoral assessments that will be conducted next week. UNDAC can provide communications, logistics and coordination support for these missions.

• National response
- Today, Ghana Air Force planned to conduct 3 helicopter rotations to Daboya to deliver relief items from the Government and UNICEF. The relief consisted of medicine, water purification tablets, cooking utensils, hygiene kits, blankets, school in a box, tents, tarpaulins, toilet soap and mosquito nets.
- The Ghanaian military engineers offered assistance provided funds can be allocated for materials and basic reconstruction equipment.


• Bi-lateral response
- DFID humanitarian advisor from London departed tonight.

International Regulatory Affairs Focus: Malaria Treatment and Prevention

International Regulatory Affairs Focus: Animal Genetic Resources
10 September, 2007. SUMMARY OF THE FIRST INTERNATIONAL TECHNICAL CONFERENCE ON ANIMAL GENETIC RESOURCES FOR FOOD AND AGRICULTURE: 3-7 SEPTEMBER 2007. Source: Earth Negotiations Bulletin. Vol. 9 No. 387. Monday, 10 September 2007. Published by the International Institute for Sustainable Development (IISD). The event was attended by an estimated 290 participants representing over 100 countries, as well as numerous UN agencies, intergovernmental organizations and non-governmental organizations.

However, most of the conference was taken up with negotiations on the draft Global Plan of Action for Animal Genetic Resources and on the Interlaken Declaration on Animal Genetic Resources.

International Regulatory Affairs Focus: Pharmacovigilance in Developing Countries
09 September, 2007. Pharmacovigilance in developing countries. Requires collaboration between stakeholders to develop novel models of funding. Source: BMJ 2007;335:462 (8 September), doi:10.1136/bmj.39323.586123.BE. Efforts are increasing to ensure that resource poor countries, which bear almost 90% of the global disease burden, have access to effective medicines.1

International Regulatory Affairs Special Focus on Avian influenza H5 Test Results

International Regulatory Affairs Focus-Lung Cancer Drugs

International Regulatory Affairs Focus: RAPS 2007 Awards
PRESS RELEASE: Fort Dodge, Iowa. 28 August, 2007. International Regulatory Affairs Updates (IRAUP.COM) founder recognized with the prestigious Regulatory Affairs Professionals Society (RAPS) first Global Leadership Award .

Solomon Sackitey, founder of IRAUP.COM, a Virtual Regulatory Affairs Library, was recently honored with the Global Leadership Award by RAPS for his devoted services to RAPS and for contributions towards advancing knowledge of the noble Regulatory Affairs profession across various societies and economies worldwide. In addition, he was recognized for his dedication and contributions to the University of Arkansas at Pine Bluff (UAPB) and its Regulatory Science Program which is thought of as the first of its kind in the world.

Sackitey, a United Nations Volunteer of the Year 2006 Award recipient , is DatelineHealth Africa (DLHA) Avian influenza H5N1 (bird flu) news alert sub-editor and a regular contributor of health-related articles on the West Africa Doctors and Healthcare Professionals Network (WADN). He is a Senior Regulatory Affairs Specialist at the Animal Health Dision of Wyeth and a member of the International Society for Biosafety Research (ISBR).

About International Regulatory Affairs Updates

International Regulatory Affairs Updates, located in Fort Dodge, Iowa, is a partnership with Storm Group Internet Solutions, located in Western Philadelphia suburb. It provides this Virtual Library as a free resource for Regulatory Affairs Professionals, Regulatory Agencies and Consumers alike to get more knowledge about various aspects of Regulatory Affairs pertaining to Human and Animal Medicinal products, Medical Devices, Traditional-Herbal Medicines and Biosafety issues.

About RAPS

With more than 11,000 individual members from industry, government, research, clinical and academic organizations in more than 50 countries, RAPS develops professional standards for knowledge, competency and ethics and is the leading source of information on the scope of practice of regulatory professionals and their critical roles in the health sector .

Additional information about RAPS Awards: 2007 RAPS Awards .

Herbal Medicines Clinical Trials- International Regulatory Affairs Focus

Gene Therapy Death- International Regulatory Affairs Focus
29 July, 2007. Patient Dies in Gene Therapy Experiment. FDA Suspends Study, Begins Safety Review of 28 Other Gene Therapy Trials. Source: ABC News. By DAN CHILDS; ABC News Medical Unit. July 26, 2007. The death of a patient enrolled in the clinical trial of an experimental gene therapy treatment has spurred the U.S. Food and Drug Administration (FDA) to halt the trial and begin safety reviews of 28 other gene therapy trials around the country.

Worldwide Counterfeit Drug Menace- International Regulatory Affairs Focus

Multibillion Dollar Dietary Supplements Market- International Regulatory Affairs Focus
29 July, 2007. International Irony: China Investigates U.S. Diet Patch; Americans Spend $22 Billion a Year on ’Natural’ Dietary Supplements That Escape Regulation. Source: ABCNews.By SUSAN DONALDSON JAMES; July 11, 2007. The diet herb hoodia gordonii claims to stave off hunger in teens and South African bush men. The product is popular as a transdermal patch, and some psychologists and doctors worry advertising is aimed explicitly at body-conscious young girls. The industry as a whole is virtually unregulated. (photodisc)

Illegal Genetically Modified Fish-International Regulatory Affairs Focus
27 July, 2007. Genetically-modified tropical fish seized. Source: New Zealand Herald; 1:08PM Thursday July 19, 2007. Biosecurity New Zealand has seized and destroyed 300 genetically modified tropical fish.

Biotechnology Standards-International Regulatory Affairs Focus

Malaria Vaccines Update- International Regulatory Affairs Focus

HIV/AIDS Drugs and Vaccines Update- International Regulatory Affairs Focus

International Health Regulations: International Regulatory Affairs Focus
14 June 2007; International Health Regulations enter into force; New opportunity to respond to international public health threats.

Source: World Health Organization (WHO). 23 June 2007: Date posted on International Regulatory Affairs Updates website.

GENEVA -- The revised International Health Regulations (IHR) enter into force on Friday, 15 June. The Regulations establish an agreed framework of commitments and responsibilities for States and for WHO to invest in limiting the international spread of epidemics and other public health emergencies while minimizing disruption to travel, trade and economies.

Food-borne Terrorism Tracking Software: International Regulatory Affairs Focus
15 June 2007. FDA Press Release. FDA Releases New Software Tool to Help Keep Food Facilities Safe from Attack . Latest Effort in Strengthening U.S. Food Defense.

CARVER + Shock: Enhancing Food Defense.

16 June 2007: Date posted on International Regulatory Affairs Updates website.

The U.S. Food and Drug Administration (FDA) today released a new tool to help growers, packers, processors, manufacturers, warehousers, transporters, and retailers in the food industry determine the vulnerability of individual food facilities to biological, chemical, or radiological attack.

International Regulatory Affairs Focus: African Biotechnology Policy Action Recommendations- II
The Success Of Biotechnology Goes Beyond Regulation: Responsible Citizenry Is The Key. A CASE FOR POLICY ACTION IN AFRICA: PART II


Solomon K. Sackitey, Senior Regulatory Affairs Specialist and Molecular Biologist

Date Published: 07 January 2007

Date Posted: 26 January 2007

Earlier in the week, the first segment of this article was published to raise awareness about biotechnology applications outside of the human healthcare industry by drawing attention to agricultural, environmental and industrial sciences as being part of the healthcare industry in a broad sense.

“Jumping Genes” (transposable elements) were used to provide an illustration of natural biotechnology tools. Besides, the benefits and risks of biotechnology and tragedies in recent history have been explored. “Old biotechnology” has been shown to be practiced in Africa for centuries before “modern biotechnology” has become a household terminology. In essence, biotechnology is not new to Africa.

The Addis Ababa Convention which on 22nd January brought various participants to the 2007 African Union Summit continues through 30th January 2007 with high- level policy-makers paying a lot of attention to the hopes and aspirations that Science and Technology could bring in solving the continent’s deforestation, malnutrition, hunger, drought and health problems. In March 2007 when African ministers and other elite policy-makers gather in Accra, Ghana to celebrate Ghana’s 50th Independence , it is again anticipated that technological advancements in Africa’s future will feature prominently on numerous agenda items.

The final session of this report is largely dedicated to recommendations for policy action in Africa and the use of biotechnology in human healthcare. Applications of molecular diagnostics as it relates to disease detection, paternity dispute resolution, criminal cases, food-borne pathogen detection and the detection of contaminated Genetically Modified Organisms (GMOs) in approved GMO products have been reviewed.

Training needs, Intellectual Property Protection, Regulatory Affairs and Biodiversity issues are vital to biotechnology policy action in Africa.

Use of Biotechnology In human healthcare

It is worth pointing out that Genetically Modified Organisms are not only applicable in agriculture but are also feasible in human health.

An array of biotechnology applications has accelerated the drug development process leading to novel and more efficacious drugs and vaccines thus contributing to increased healthcare options. We are better equipped to prevent, treat and cure otherwise incurable diseases.

Health problems posed by malaria in the tropics especially in Africa have been around for generations. An international effort involving the Tanzania’s Ifakara Health Research and Development Centre, the University of Nairobi in Kenya, the National Institute for Medical Research in Dar es Salaam, Tanzania and the International Atomic Energy Agency in Austria has been working on developing genetically modified mosquitoes to help the fight against this disease which costs the African continent $3billion/year.

One aspect of biotechnology that will pay off for Africa is an extension of this technology to African traditional and herbal medicines. By sequencing the genomes of plants used in the practice of this ancient medical practice and preserving the Genetic Resources of such plants, Africa will have a broad-based biotechnology solution to healthcare problems.

Molecular Diagnostics

Biotechnology is not all about food production. It also provides us with tools for quick and sensitive detection of disease pathogens, food-borne pathogens, use in forensic and criminal cases where convicted innocent people have been set free using DNA technology while others have been convicted based on DNA technology evidence. All these are possible through various methodologies, for example, Molecular Diagnostics which is a rapidly growing area of Biotechnology.

According to a recent report entitled "Molecular Diagnostics - Technologies, Markets and Companies” , in the year 2005, the global market for molecular diagnostics was worth $6.5 billion accounting for nearly 3.3% of the total diagnostics market and close to 14% of the in vitro diagnostic market. The report forecasted, Molecular diagnostics market will expand to $12 billion by 2010 and $35 billion by 2015.

Molecular diagnostics is vital in numerous aspects including public health. For example, in food-borne pathogen detection of E coli O157:H7 , Crime laboratories whereby a convicted innocent person could be set free or a sex offender could be convicted. In Paternity cases, DNA technology could be used to determine the biological father of a child. With regards to Bioterrorism cases involving food and water-borne poisoning or bird importation/exportation, this type of technology can be very useful. Plant pathologists and entomologists also have this tool at their disposal for determining which pathogens cause which diseases or which insects are responsible for crop losses, respectively.

And in the case of Genetically Modified Organisms, molecular diagnostics will play a major role in fishing out contamination with contraband, unapproved GMO products in shipments of or in any given population.

The formation of Regional GMO Diagnostic Centers in Africa that will be responsible for monitoring the quality of GMO products by detecting contaminations of unauthorized GMO or related products will be a wise investment.

Policy Action Recommendations

1. African Biotechnology Professionals Database (ABPD)

The development of an African Biotechnology Professionals Database (ABPD) to involve professionals in Africa and in the Diaspora including scientists, bioinformaticists, healthcare professionals, academicians, legal practitioners , religious leaders and regulatory affairs professionals to include their research efforts, publication lists, patents and other relevant information for African Biotechnology policy makers to tap into for consultations and mentorship should be given a serious consideration.

2. Incentives for African Women in Biotechnology

Africa has for too long lagged behind in attracting women into Science, Technology, Engineering and Mathematics. Establishing special incentives for enticing African women into Biotechnology Research and Development could pave the way for enhancing solutions to healthcare problems such as breast cancer. Incentives for African Women in Biotechnology who could be a powerful force to reckon with in enforcing health and technology policy change in Africa and thereby making enormous contributions to the Millennium Development Goals. Policies should encourage the establishment of private businesses by providing tax incentives for women-owned biotechnology firms, for example.

3. Communications

Series of speculations and misconceptions dominate Biotechnology headline news. There have been reports stating that “potential dangers from the rapidly growing biotechnology industry were increasing exponentially” and warnings of "catastrophic" results if recent advances in biotechnology, including gene manipulation and work with viruses, fell into the wrong hands. See the sections on (a) < b>Regulatory Affairs , (b) Tragedies in Recent Memory (c ) The “Threat” of Biotechnology versus The “Threat” of Nature and (d) “Jumping Genes”: A Versatile Naturally Occurring Biotechnology Tool for clarifications.

Mounting of training programs or workshops for science journalists and the general public including policy makers would be a great asset in bridging the huge communications gap. Such communication awareness efforts must make room for the consumer’s voice to be heeded to and understood clearly.

The acceptance or rejection of GM foods will depend, to a large extent, on the consumer whose input on palatability tests, popping quality of corn and kneading quality of tubers and other crops is indispensable.

News coverage must also effectively analyze not only the risks but the benefits of biotechnology. In the absence of the aforementioned approaches, biotechnology products won’t be a practical success: they may be merely an academic endeavor.

4. Training

In order for Africa to play a leading role in international healthcare and in defining biotechnology policies, accelerated training programs and funding for establishing biotechnology facilities at Regional and National levels would be needed. An increased participation/submissions in grants-seeking projects could help Africa’s presence in the global healthcare arena.

African biotechnology policy makers should consider formulating Scientist-Teacher partnerships in diverse communities both locally and internationally. Through such partnerships, high school science teachers will be granted fellowships to participate in mentoring by scientists and researchers in pharmaceutical companies, organizations and in academia. Such mentoring activities could also be done over the internet in online programs.

While the internet is becoming more and more popular, the masses don’t have easy access and if they do, they end up paying a huge percentage of their income. Upon all these, internet connectivity has been erratic and unreliable. Until such a time that the internet becomes more affordable and reliable connectivity has been established, policy makers may consider incentives for producing training materials on CD-ROMS and in booklet forms.


5. Regulatory Affairs

Biotechnology, like any other technology, has its limits. Taking things too far (beyond limits) always raises eye brows. There needs to be guidelines or regulations on where to draw the line i.e. what is ethical and what is not.

Genuine technologies of any kind could be abused or misused by unscrupulous individuals and that is the reason for not only making policies but enforcing them.

Airplanes have been instrumental in enhancing trade and commerce but have also been demonstrated by terrorists in causing astronomical human casualties in the United States on 11 September 2001. Biotechnology has numerous benefits to humankind but could also be abused very easily. For purposes of preventing such abuses, African biotechnology policy makers need to establish Regulatory harmonizations in Africa.

In addition, the development of Regulatory science curricula at the undergraduate and high school levels in African academic institutions would be a plus. For example, collaborations with foreign academic institutions such as the Regulatory Science program at The University of Arkansas at Pine Bluff (UAPB) in the United State which is believed to be the first in the world to have a Regulatory Science degree program at the undergraduate level could be of immense help. The UAPB faculty includes Drs. Linda Okiror and Shadrach Okiror who have rich experience in Agricultural Research in Africa.

Regulation of biotechnology is not going to be cheap. A 2005 report on the regulation of small business of fewer than 20 employees indicated a cost in excess of $1.1 trillion dollars in the United States alone. Effective biotechnology regulation goes beyond financial costs and policy enforcements. Responsible citizenry is an answer to avoiding catastrophic events.

If the continent does not set up and enforce regulatory guidelines, this would mean they are open to receiving any product, be it safe or unsafe. Making policies is one thing and taking policy action is another. What good is there if policies or regulations are made but not enforced? Let’s see these policies translated into actions!.

6. The Cartagena Protocol on Biosafety

There have been reports of accidental mixture of unapproved GM pesticides in exported seeds. It is for such accidental mixtures and other accidents that the Cartagena Protocol would be a good safeguard.
The Protocol, a multinational agreement set up under the United Nations Convention on Biological Diversity, serves as an instrument for various countries to make their own informed decisions prior to importing any Genetically Modified product.

As of Friday, December 29, 2006, 137 ratifications have been recorded with the UN Secretary-General from various Parties to the Convention on Biological Diversity including the following thirty-nine (39) African countries: Algeria, Benin, Botswana, Burkina Faso, Cameroon, Cape Verde, Chad, Congo, Democratic Republic of the Congo, Djibouti, Egypt, Eritrea, Ethiopia, Gambia, Ghana, Kenya, Lesotho, Liberia, Libyan Arab Jamahiriya, Madagascar, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Seychelles, South Africa, Sudan, Swaziland, Togo, Tunisia, Uganda, United Republic of Tanzania, Zambia, Zimbabwe.

7. Intellectual Property Rights

Biotechnology policy makers in Africa must set up rules and incentives for African scientists who make significant contributions in innovative Biotechnology research and development through either independent or collaborative efforts in cross-functional teams to seek intellectual property protection such as country-specific, international or worldwide patent(s).

For a selected list of resources on Intellectual Property protection in Africa, see Intellectual Property. Such resources include African Intellectual Property Organization with headquarters in Yaoundé, Cameroon and an “African Regional Workshop on IP Office Automation" organized by the World Intellectual Property Organization (WIPO) in Harare, Zimbabwe.

Conclusions

For a meaningful use of biotechnology tools in Africa, there should be a high-energy policy-making consortium made of personnel from academic institutions, government agencies, non-governmental organizations, industries, regulatory agencies and consumer advocates. As biotechnology is gaining global momentum, it is essential that the end-users of this rapidly growing field become fully aware of the benefits as well as any possible risks. Gone are the days when the consumer will just accept anything “as is” and not provide any feedback. Consumer awareness is skyrocketing and it must continue. There have been reports stating that when you are hungry, safety is not an option. Sorry, this is just not ethical to try and pressurize anyone to eat anything unsafe just because an individual is hungry.

Prior to biotechnology products appearing on African markets, it is imperative that detailed safety, efficacious and ecological studies be conducted by African and International Regulatory Bodies, African scientists and African health research institutions. The establishment of Regional Environmental Protection Institutes in Africa charged with the responsibilities of developing strategies for monitoring and protecting the Environment should be given serious consideration.

In addition, programs that will minimize or eliminate deforestation will be desirable. Such Regional Institutes would need to be established under the joint auspices of World Health Organization (WHO) and The United Nations Food and Agricultural Organization (FAO).

A serious communications gap is deepening with regards to biotechnology news dissemination which is engulfed in suspicions and misconceptions. Training and awareness programs for both science reporters and the general public including policy makers will be instrumental in bridging this gap.

The success, confidence and reliability of biotechnology in Africa will be meaningless unless it is integrated with international efforts for the total eradication of hunger, malnutrition, poverty and poor health. Biotechnology or any other technology, must be devoid of greed, self-aggrandizement, aggression, power and intimidation.

A true biotechnology success factor will be strongly influenced by World Peace, Political stability and Religion. It appears that civilization is suffering in contemporary lives. The number of murders and acts of inhumanity over the past 4-5 decades appear to be in exponential proportions compared to the past century.

Humanity is losing sight of The Lord. We need to seek God’s guidance and light as we try to make strides in improving public health through bioscience. For, “In Thy Light, We Shall See Light”, says the motto of a famous African high school.
==============================================================
Solomon, a Datelinehealth-Africa (DLHA) News Service Avian influenza (H5N1) Alert sub-editor is DLHA award winning United Nations Online Volunteer of the Year 2006 . He was also the 2006 inaugural lecturer in the seminar series of the Science, Technology, Engineering, and Mathematics (STEM) Program and Gamma Sigma Delta (GSD), the Honor Society of Agriculture at the University of Arkansas at Pine Bluff (United States) speaking on the topic “Food Safety in a Small World: Genetic Engineering, Regulation and Molecular Diagnostics.” The research work of Solomon and his colleagues includes publications on HIV/AIDS DNA Vaccines , E. coli O157:H7 detection and Maize Transposable Elements .

Additionally, he has authored series of articles (eg. 1 , 2 and 3 ) on the “bird flu” through which he contributed to “developing and managing knowledge ” by stimulating the “formulation of action plans, guiding policy processes and supporting research on Avian influenza for African countries .” (UNV news release : en español , en français and in English ).
==============================================================
Disclaimer: This report shares the personal views of the author and it is not an endorsement nor a representation in any way of any and all third parties and/or sources mentioned or cited.

(C) 2007-2020 Solomon K. Sackitey.

International Regulatory Affairs Focus- Biotechnology Not New In Africa
07 January 2007. AGRICULTURAL BIOTECHNOLOGY PARTNERSHIPS IN AFRICA Source: The Consultative Group on International Agricultural Research (CGIAR)


BIOTECHNOLOGY IS NOT NEW IN AFRICA
o Four CGIAR Centers – The Africa Rice Center (WARDA), IITA, ILRI, and World Agroforestry Centre – are headquartered in Africa.
o In addition. the Syria-based International Center for Agricultural Research in the Dry Areas (ICARDA) works in North Africa.
o CGIAR Centers have 54 regional/outreach offices in Sub-Saharan Africa.
o CGIAR invests more than 47 percent of its annual budget ($ 400 million in 2004) for creating solutions to problems of African farming.

Partneships with Africa through Biotechnology
For over three decades, CGIAR has been a strong partner in Africa’s development, providing new crop and farming technologies through programs such as:

New Rices for Africa (NERICAs) developed by The Africa Rice Center (WARDA) provides higher yields, drought tolerant and thrive in salty soils helping countries cut crippling rice import bills.

The demand for rice in West and Central Africa (WCA), the rice belt of Africa, is growing at the rate of 6% per annum—faster than anywhere else in the world. Since the 1960s, rice imports in the sub-region have increased eight-fold to 4 million tonnes per year, at an annual cost of over US$1 billion.

NERICAs Benefits from Biotechnology in Africa
Higher yields (by 50% without fertilizer and by more than 200% with fertilizer), Earlier maturity (by 30–50 days), Resistance to local stresses and Higher protein content (by 2%).

Potential Economic Powerhouse
Because of this unique technology package, NERICAs have a huge potential economic impact in Africa for: Feeding subsistence farmers’ households, Generating surplus harvests, Boosting income and consumption and Reducing imports and saving foreign exchange.

WARDA Strategic Plan includes Genetic Resources Conservation to facilitate Germplasm Enhancement in Africa.

New, improved, drought-resistant maize (Zea mays L.) varieties adapted for harsh ecologies of southern Africa are planted 30 percent higher yields (CIMMYT).

Quality protein maize , containing twice the amount of beneficial nutrients such as lysine and tryptophan, is boosting household nutrition in Africa and elsewhere. QPM is currently planted in 25 countries, many of which are in Africa (CIMMYT) .

CIP’s Vitamin A for Africa (VITAA) Partnership is helping tackle one of the most pressing health and nutrition problems in Sub-Saharan Africa: Vitamin A deficiency (VAD). New, orange-fleshed sweet potato varieties with enhanced beta-carotene are proving valuable in the fight against VAD that affects some 3 million children in Sub-Saharan Africa who are under the age of five (CIPOTATO).

Sorghum, millet, groundnut, chickpea and pigeonpea : Close partnerships between African researchers and ICRISAT over three decades created improved varieties of sorghum, millet, groundnut, chickpea and pigeonpea being grown on a million hectares each year. Both smallholder farmers and poor consumers benefit from higher yields, better food quality, resistance to diseases and pests, and earlier harvest of their crops, lowering drought risk. The joint research, based in Burkina Faso, Kenya, Mali, Malawi, Kenya, Niger and Zimbabwe helped all the countries in the Sahelian, Kalahari and East African drylands (ICRISAT).

Livestock provide draft power, milk and meat. In much of Africa, livestock are a symbol of wealth and social status. ILRI scientists working in Ethiopia’s remote Ghibe Valley are tackling a trypanosomosis epidemic that has felled hundreds of zebu cattle. The benefits of this research included increases in farmers’ herd sizes (ILRI) .

Cassava mosaic disease cuts cassava production in Africa by 15 to 25 percent. In late 1980s, the disease affected Uganda, Kenya, Sudan and Tanzania. Thanks to efforts by IITA researchers and partners, new disease resistant cassava varieties have boosted production in Uganda to a record high of 5 million tons, up from a low of just 2 million tons at the worst phase of the epidemic (IITA) .

• Every year, stem borers voraciously consume 400,000 tons of maize causing an estimated $72 million in losses for Kenya. That sum represents over 12 percent of the farmers’ annual harvest. Researchers from CIMMYT, working in close cooperation with Kenya Agricultural Research Institute are collaborating to identify conventional and novel sources of stem borer resistance and incorporating them into maize varieties that are well suited to Kenyan growing conditions and to farmer and consumer preferences ( (CIMMYT) , (KARI) .

Locusts are the bane of farmers in Africa. IITA researchers and partners have developed an environmentally-friendly biopesticide “Green Muscle.” It uses a naturally occurring fungus strain indigenous to Africa (Metarhizium anisopliae) which is deadly to locusts and grasshoppers but does not damage other insects, plants, animals, or people. Typically 70 to 100 percent mortality rates were obtained after 8 to 28 days of application (IITA) .

• Researchers at World Agro forestry Centre are promoting agroforestry – the planting of trees on farms – as a means to improve fertility of nutrient-depleted soils. In Embu District of eastern Kenya, more than 3,000 farmers are planting tree legumes in fodder banks for use as an inexpensive protein supplement for their dairy cows

Biodiversity and Plant Genetic Resources
Biological diversity - or biodiversity - refers collectively to the variety of life on earth. Biodiversity forms a "web of life" of which human beings are an integral part and upon which they fully depend. Plants, including food crops, are an important part of this biodiversity, vital for nourishing and sustaining human society. Biodiversity provides enormous benefits, including aesthetic, cultural, ecological, economic, educational, environmental, genetic, medical, recreational, scientific, and social services Biodiversity and Plant Genetic Resources .

International Regulatory Affairs Focus- African Biotechnology Policy Action Recommendations- I
The Success Of Biotechnology Goes Beyond Regulation: Responsible Citizenry Is The Key. A CASE FOR POLICY ACTION IN AFRICA : PART I

Solomon K. Sackitey, Senior Regulatory Affairs Specialist and Molecular Biologist
Date Published: 07 January 2007
Date Posted: 23 January 2007

As the African Union Summit 2007 convenes in Ethiopia’s national capital of Addis Ababa from 22nd through 30th January 2007 , high- level policy-makers will be addressing various issues including the impact of Science and Technology on the continent’s development. At the same token, when African ministers and other elite policy-makers gather in Accra, Ghana, in March 2007 to celebrate Ghana’s 50th Independence , it is anticipated that technological advancements in Africa’s future will feature prominently on numerous agenda tables. One area of technology that is making major headlines particularly in Africa and across the globe in general, is Biotechnology . The aim of this article is to drive home to Africa’s Science, Technology and Innovation experts who are at the helm of a policy overhaul, numerous thought-provoking issues to stimulate their minds.

Part I of this story takes a look at the healthcare industry in general which includes agricultural, environmental and industrial sciences.

An illustration of natural biotechnology tools, the benefits and risks of biotechnology and tragedies in recent history have been covered. In addition, an attention is directed to the fact that biotechnology is not new to Africa.

The second and final part of this article is largely dedicated to recommendations for policy action in Africa, the use of biotechnology in human healthcare, applications of molecular diagnostics in disease detection, paternity disputes, criminal cases, food-borne pathogen detection and the detection of contaminated Genetically Modified Organisms (GMOs) in approved GMO products. Training needs, Intellectual Property Protection, Regulatory Affairs and Biodiversity issues have also been covered.

Executive Summary

All around the world, it is believed that the healthcare industry pertains only to human medicine. Other aspects of the healthcare industry include agricultural, environmental and industrial sciences.

With the entry on the world market of many Genetically Engineered products, sometimes loosely referred to as Genetically Modified Organisms (GMOs) , the general population is concerned about the safety of these products as they relate to human, animal and environmental health. A great deal of these concerns are attributable to communication flaws. Increased knowledge comes with the power to make well-informed decisions.

This report is an effort to ease the fears in people by taking a look at biotechnological events that have been taking place in nature, tragedies that occur in nature, how modern biotechnology is being used by humankind and the chances of human beings abusing or misusing biotechnology for unscrupulous means.

Esteemed African policy makers are particularly urged to give serious considerations to the following recommendations :

(a) making provisions for enticing African women into Science, Technology and Innovations

(b) creation of an African Biotechnology Professionals Database

(c) the formation of an African Regulatory Affairs Network

(d) Regional GMO Diagnostic Centers of Excellence

(e) Biotechnology training programs for High School teachers

(f) the establishment of Regional Environmental Protection Institutes

(g) Intellectual Property Rights enforcement

(h) Science Journalism

(i) listening attentively to the consumer’s voice

(j) improved mechanized food processing technologies and

(k) a continental and global system for safeguarding the risks of biotechnology .

A true biotechnology success factor will be strongly influenced by World Peace , Political stability and Religion . It appears that civilization is suffering in contemporary lives. The number of murders and acts of inhumanity over the past few decades appear to be in exponential proportions compared to the past century.

Humanity is fading away from Religious beliefs. We need to seek God’s (Allah’s) guidance and light as we try to make strides in improving public health through bioscience. For, “In Thy Light, We Shall See Light”, says the motto of a famous African high school.

Introduction

A universal misconception of the Healthcare industry relates only to business and research activities in human medicine. Agriculture, Environmental science and Industrial Safety are all part of the General Healthcare Industry.

As more and more farm lands , around the world are being planted with Genetically modified crops and the global market value of Genetically modified crops is in excess of US$ 6 billion and 222 million acres(depending on the source of information), people of all walks of life are becoming more and more curious about Genetically Modified Organisms (GMOs).

This curiosity spans concerns ranging from human nutrition, human safety, regulations, environmental safety, intellectual property rights and bio-energy. At the same time, prevailing issues that surround these concerns include communication gaps leading to misconceptions, suspicions and speculations. All these issues and concerns are valid and have merit.

This report is an analysis of how Biotechnology could impact various aspects of the Healthcare Industry in Africa. It is intended to promote the advancement of knowledge and foster networking among high-level policymakers from the United Nations Economic Commission for Africa (ECA)’s ICT, Science and Technology Division (ISTD), The African Union, The African Development Bank, various African countries and African Regional Consortia who need to take a first-hand look at all Biotechnology issues aimed at benefiting the continent.

Such issues would include, but not limited to, (a) making provisions for enticing African women into Science, Technology and Innovations, (b) creation of an African Biotechnology Professionals Database, (c ) the formation of an African Regulatory Affairs Network, (d) Regional GMO Diagnostics Centers of Excellence, (e) Biotechnology training programs for High School teachers, (f) the establishment of Regional Environmental Protection Institutes, (g) Intellectual Property Rights enforcement, (h) Science Journalism, (i) the consumer’s voice, (j) Mechanized food processing technologies and (k) a continental and global system for safeguarding the risks of biotechnology.

A call for aggressive genome sequencing projects is warranted. This way, we would have a thorough understanding of the genes and their functions in what is known as Functional Genomics. Major efforts are needed to preserve plant germplasms so as to maintain a pool of agronomic and pharmaceutical characteristics.

Modern biotechnology should not be a substitute for “old” biotechnology. They must both go on simultaneously. For example classical genetics and molecular genetics should be funded generously.

Where biotechnology risks become a reality and inflict an individual’s toil and labor such as economic and health issues, policy makers need to have a strategy and an implementation plan for compensating those affected. Some form of insurance policy needs to be included in African Biotechnology policy makers’ agendas.

What is Biotechnology ?

When the general population hears of the word “Biotechnology” or “Genetically Modified Organism” (GMO), they feel chills in their spines. To some people, Biotechnology is synonymous with extraterrestrial mutagens invading the earth. Other people are inclined to think that Biotechnology is a “new” “man-made” technology. These unfounded fears or superstitions could be attributed largely to a lack of knowledge or misinformation about this promising area of a hybrid of old and “new” technologies. So, just what is Biotechnology all about ? It is a broad term describing the use of chemistry, biology and the physical sciences in industrial and academic applications including human healthcare, animal health and in plant healthcare.

Of late, this word is used interchangeably to refer to the production of genetically modified organisms or the manufacture of products from genetically engineered organisms. Such products encompass DNA vaccines for human and animal health, nutritionally superior crop plants and DNA modified mosquitoes to help fight malaria.

“Jumping Genes”: A Versatile Naturally Occurring Biotechnology Tool

If you have ever eaten corn (maize) kernels with specialized spots on them, you probably have eaten a natural genetically-modified corn. Such spots are the results of genetic events by transposable elements or “Jumping Genes” which are pieces of DNA that move from one place to another in the genome of an organism. Barbara McClintock’s research on maize transposable elements has provided insight into genetic research and was the subject of the 1983 Nobel Prize in Physiology and Medicine.

Writing about “Jumping Genes”, Nina Fedoroff, reported that a “Jumping Gene” or transposable element is a piece of DNA (deoxyribonucleic acid) that moves from one place to another in the genome of an organism. This movement can cause mutations or rearrangements of chromosome, thereby modifying the expression and the structure of genes and genomes. “It is as if “jumping genes” can amplify a small genetic turbulence, turning it into a genetic earthquake. Perhaps, such genetic turbulence is an important source of variability, the raw material from which natural selection can sift what is useful for the species” (Transposable Genetic Elements in Maize. Scientific American; Vol 250; June 1984).

One such “Jumping Genes” popularly known in the literature and among colleagues as the Robertson’s mutator was discovered by Dr. Donald S. Robertson, Professor-Emeritus at Iowa State University’s Genetics Department. This genetic element has been used around the Globe by transferring the superior nutritional quality traits from the maize yellow endosperm into rice to enrich the nutritional values of rice, a staple food in many developing countries [See Sackitey (Iowa Agriculturist; Fall 1986. “Jumping Genes” Put Genetics On The Move)].

Biotechnology is not new to Africa

Africa is home to many institutions involved in Agricultural Biotechnology. The Consultative Group on International Agricultural Research (CGIAR), for example, has made series of contributions through its associated organizations in various regions of Africa by producing higher rice yields and increased nutritional crops. African small farmers have for centuries practiced biotechnology through the selection of crops and in animal breeding.

Benefits of Biotechnology

The areas where biotechnology offers numerous benefits to humankind include high nutritional quality of food crops such as rice, corn, tomatoes, high yielding crops, insect resistance crops and drought tolerance. Cassava is a major source of energy food in Africa but it can produce a highly poisonous compound called cyanide which can be more fatal to people who get little or no protein in their diets because they lack the proper amino acids necessary to help detoxify this poison. As this toxin gets released into the air, the proper way to avoid cassava cyanide poisoning is by sun-drying the tuber and leaves prior to cooking.

This style of food processing contributes to environmental contamination which could be particularly serious in areas where there is large-scale air drying of cassava. On the other hand, modern biotechnology is providing us with the tools to make-cyanide-free cassava through genetic engineering so as to avoid the hassles of drying cassava products which end up contaminating the environment. This is exactly what Siritunga and Sayre have been doing to create cassava plants whereby this important food crop will no longer pose a major threat to humankind.

Finding ways and means to monitor the level of cyanide in the air and depleting it in the environment through modern biotechnology could be a long lasting technology landmark.

In others areas, biotechnology offers the protection of Animals against diseases like West Nile virus, a mosquito-borne disease, the ability for certain livestock to produce more and better meat and milk. In another instance, Scientists have cloned a few farm animals which include a sheep , a goat , a cat and a dog with the aim of providing the farmer with more economic returns and additional options for generating pharmaceutical raw materials. In aquaculture, genetic engineering of fish is allowing higher yields and disease resistant fish crops.

Another application of Biotechnology involves the engineering of naturally biodegrading microorganisms in the soil to over-express genes that could be used to clean chemical contaminants in the environment. Pharmacogenomics, the study of how genes in a person interact with drugs, is another area of biotechnology with expected gains to humankind.

Risks of Biotechnology

The “Threat” of Biotechnology versus The “Threat” of Nature
Biotechnology is occurs in nature all the time. There are open-pollinations among plants of the same species or different species in what is known as cross-species pollinations resulting in new plants or mutants. In controlled pollinations, pollen grains are collected and used to pollinate other plants to meet desired research goals. In either natural or artificial pollination techniques, “new” plants or mutants are produced. Some of the progenies produced end up being desirable or undesirable. In a similar fashion, natural mating and controlled mating occur in animal breeding.

With the concerns of many individuals about technology disasters such as Chernobyl and the explosion of NASA’S Challenger, one may ask if there is any danger of biotechnology tools being harmful to humans, crop species, animals and the environment, or modifying the human genome. The general public should be aware that jumping genes are not just in corn but in plants. “They are everywhere. They are found in yeast, meat, bacteria, animals and humans. If there is any danger in using jumping genes, nature probably poses a bigger threat than do the genetic engineers because gene rearrangements occur in nature all the time; besides we did not create jumping genes. They are already there in the genome”, said Brian Schafer (Sackitey: Iowa Agriculturist; Fall 1986. “Jumping Genes” Put Genetics On The Move).

Tragedies in Recent Memory

Whilst the fear of Biotechnology appears to be exaggerated it does not mean it could not cause problems or be abused. Just like any other technology, biotechnology or Genetic Engineering could encounter accidents or be misused. There have been numerous accidents and incidents in recent history which relate to technology in general. The following are just a few examples:

(a) 1984: Hundreds die in Bhopal chemical accident which is believed to be the worst industrial accident in the world and also in India’s history.

(b) 1986: The Chernobyl Nuclear accident in which case 54 people lost their lives as the result of a malfunctioning nuclear reactor in Ukraine.

(c ) Counterfeit and Adulterated Drugs An ongoing problem: where it is estimated that more than 30% of marketed medicines in African countries can be counterfeit. This translates into multibillion United States dollars.

(d) December 2004: Tsunami Disaster which impacted several countries in Eastern Africa (Kenya, Tanzania, Somalia and the Seychelles Islands) and Asia with over 170,000 human casualties, several thousands of human lives unaccounted for and millions of people rendered homeless.

(e) The Oklahoma City Bombing where 168 people were killed, 19 of whom were children when the Murrah Federal Building was bombed using locally made devices including fertilizers.

(f) Bioterrorism Ongoing threat: awareness and preparedness initiatives have been heightened since the 11 September 2001 attack in the United States by terrorists who hijacked various commercial airliners. Over 3,000 people were reported dead and several others missing.

(g) February 2003: NASA’s Columbia Shuttle Disaster that killed all seven astronauts on board after the shuttle exploded.

(h) HIV/AIDS Ongoing threat: has ongoing devastations worldwide where it has been estimated that millions of people have died, are living with AIDS and being infected with the dreaded virus.

Recommendations for policy action on Biotechnology in Africa, Regulatory Affairs, Intellectual Property Protection, applications of the multi-billion dollar Molecular Diagnostics technology in detecting contaminated GMOs, in paternity cases, food-borne pathogen detection and biodiversity will be the focus of Part II of this report.

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Solomon, a Datelinehealth-Africa (DLHA) News Service Avian influenza (H5N1) Alert subeditor is DLHA award winning United Nations Online Volunteer of the Year 2006 . He was also the 2006 inaugural lecturer in the seminar series of the Science, Technology, Engineering, and Mathematics (STEM) Program and Gamma Sigma Delta (GSD), the Honor Society of Agriculture at the University of Arkansas at Pine Bluff (United States) speaking on the topic “Food Safety in a Small World: Genetic Engineering, Regulation and Molecular Diagnostics .” The research work of Solomon and his colleagues includes publications on HIV/AIDS DNA Vaccines , E. coli O157:H7 detection and Maize Transposable Elements .

Additionally, he has authored series of articles on the “bird flu” through which he contributed to “developing and managing knowledge ” by stimulating the “formulation of action plans, guiding policy processes and supporting research on Avian influenza for African countries.” (UNV news release : en español , en français and in English ).

==============================================================

Disclaimer : This report shares the personal views of the author and it is not an endorsement nor a representation, in any way, of any and all third parties and/or sources mentioned or cited.

(C) 2007-2020 Solomon K. Sackitey.

International Regulatory Affairs Focus- Animal Cloning: A Draft Risk Assessment
29 December, 2006. A Risk-Based Approach to Evaluate Animal Clones and Their Progeny - DRAFT. 28 December 2006, FDA Newswire - FDA Issues Draft Documents on the safety of Animal Clones.

IRA Focus- Implementing International Standards in Developing Countries

International Regulatory Affairs Focus- Novel Breast Cancer Biomarkers

International Regulatory Affairs Focus- Predicting Breast Cancer Spread
20 December 2006. Researchers find two biomarkers with potential to predict breast cancer spread. 19 December 2006. InnovationsReport-DE; Expression of two different proteins taken from primary tumor biopsies is highly associated with spread of breast cancer to nearby lymph nodes, according to researchers who say this protein profile could help identify at an early stage those patients whose disease is likely to metastasize.
In the December 15 issue of Cancer Research, the researchers say over-expression of one unidentified protein and under-expression of another is 88 percent accurate in identifying breast cancer that has spread in a group of 65 patients, compared to an analysis of lymph nodes and outcomes.

International Regulatory Affairs Focus- Traditional and Herbal Medicines Proprietary Protection

International Regulatory Affairs Focus- The GAVI Alliance

International Regulatory Affairs Focus- HIV DNA Vaccines
17 December 2006; CytoGenix DNA vaccine successful against HIV. Pharmaceutical Business Review; 13th December 2006; By Staff Writer; CytoGenix has demonstrated that its synDNA vaccine against HIV has activity in monkeys. The study involved monkeys treated with a synDNA vaccine targeting two key viral proteins (gag and env) with interleukin-15 as an adjuvant.

International Regulatory Affairs Focus- Global Clinical Trials
India simplifies clinical trial regulatory process.
Date Posted on International Regulatory Affairs Updates website: 10 December, 2006.

Outsourcing-Pharma.com; By Kirsty Barnes;
30/11/2006 - The new changes, set to come into effect as of December 1, are aimed at stamping out a lot of the delays faced when international firms conduct clinical research in India, in order to drive this burgeoning industry forward faster.


International Regulatory Affairs Focus- Fake Drugs on the Global Market
CDSCO in talks with WHO over fake drugs Date Posted on International Regulatory Affairs Updates website: 10 December, 2006.

The Economic Times.IndiaTimes.com; [PTI SUNDAY, DECEMBER 10, 2006 01:30:54 PM] MUMBAI: Concerned over rampant circulation of fake drugs in the global market, Indias apex drug control body has taken the matter to the World health Organisation as it seriously affected the public health in the country.

International Regulatory Affairs Focus- The ASEAN Community

International Regulatory Affairs Focus- India: Copycat Drug Firms
Indias copycat drug firms bid for healthy future in basic research
Date Posted on International Regulatory Affairs Updates website: 10 December, 2006. Times of Oman . AFP; Sunday, December 10, 2006 12:09:02 PM Oman Time;MUMBAI –– India’s pharmaceutical companies, which amassed fortunes copying generic drugs from the West, are facing up to the challenge of developing their own medicines.

International Regulatory Affairs Focus- New Travel Requirements
New Requirements for Travelers: U.S. Department of State: 01 December 2006. Date posted on International Regulatory Affairs Updates website: 03 December 2006.

Prior to your international travel for a Regulatory Affairs assignment, a Conference/Training or a personal travel, recent developments in Air Travel necessitate that the traveler becomes aware of current Travel Security and Planning including, but not limited to, various time zone differences and terrorism threats.

Beginning January 23, 2007, ALL persons, including U.S. citizens, traveling by air between the United States and Canada, Mexico, Central and South America, the Caribbean, and Bermuda will be required to present a valid passport, Air NEXUS card, or U.S. Coast Guard Merchant Mariner Document.

International Regulatory Affairs Focus- Food Safety
FOOD SAFETY CONCERNS UP WITH WORLD TRADE, TERRORISM ; By Rick Joslin/OF THE COMMERCIAL STAFF Friday, October 27, 2006 9:00 AM CDT; Date posted on International Regulatory Affairs Updates website: 03 December 2006.

“The regulation of food safety is extremely costly, but it can be reduced dramatically in a concerted global effort,” said Sackitey. “Health care costs can also be reduced. Awareness is a key, along with feedback to regulators and manufacturers.”

International Regulatory Affairs Focus- Global Counterfeit Medicines Estimates
Counterfeit Medicines: an update on estimates 15 November 2006; World Health Organization (WHO). Posted on International Regulatory Affairs Updates website 26 November 2006.

Analysis shows that counterfeiting is greater in those regions where regulatory and legal oversight is weaker, and therefore:

- many developing countries of Africa, parts of Asia, and parts of Latin America have areas where more than 30% of the medicines on sale can be counterfeit. Other developing markets, however, have less than 10%; overall, a reasonable estimate is between 10% and 30%;

- many of the former Soviet republics have a proportion of counterfeit medicines which is above 20% of market value -this falls into the developing country range;

- medicines purchased over the Internet from sites that conceal their actual physical address are counterfeit in over 50% of cases.

International Regulatory Affairs Focus- Bioterrorism

International Regulatory Affairs Focus- Australia’s GMP Guidelines for Foreign Manufacturers

International Regulatory Affairs Focus- Electronic Submission of Regulatory Information

International Regulatory Affairs Focus- Clinical Trials Amendment Regulations

International Regulatory Affairs Focus: E coli O157:H7 Outbreak

International Regulatory Affairs Focus: Traditional and Herbal Medicines Regulations

Regulatory Affairs Climate in Africa
A Look at the Regulation of Medicinal Products in Africa 02 October 2006.
Solomon Sackitey, Senior Regulatory Affairs Specialist.

In the past, a lot of African nations had loose or minimal requirements for the Regulation of Medicinal products.

Of late, countries like Nigeria, Tanzania, South Africa and Ghana have made some improvements in the area of Drug Regulatory Affairs by publishing current Guidelines and Regulations to include marketing registrations, clinical trials and Good Manufacturing Practices of medicinal products.

Besides, they have developed Guidelines for the registration and importation of drugs, vaccines and herbal medicines, to mention a few. See additional information on a selected list of Regulatory Bodies in Africa .

For multinational corporations seeking a good share of marketing rights in the emerging markets of African countries, and for Consultants in the Regulatory Affairs arena of the Healthcare industry, it is recommended that they acquaint themselves with new regulations in Africa.


AFRICAN DELEGATES to International Conference of Drug Regulatory Authorities (ICDRA)

With the influx of Counterfeit drugs on the global market and with increasing knowledge of prescription drug end-users, African countries have increased their participations at International Conference of Drug Regulatory Authorities (ICDRA) meetings.

For general information and educational purposes, a list of African countries represented in recent ICDRA meetings include the following:


BOTSWANA
Dr. Sinah Selelo
Drug Regulatory Unit
Ministry of Health
T: 267 3180 864
F: 267 3953 100
E-mail: sselelo@gov.bw


BURKINA FASO
Dr. Mahamadou Compaore
Services Pharmaceutiques
T: 226 20 38 66
F: 226 31 44 76
E-mail: union.pharma@liptinfor.bf


CAMEROON
Dr. Emilienne Yissibi Pola
Pharmacie et du Medicament
T: 237 222 4144
E-mail: pola@yahoo.fr


CONGO
Dr. Jerome Mpati
Services medecine traditionnelle
Direction des Service Sanitaires
E-mail:medtraco@yahoo.fr


EGYPT
Faten MOFTAH
National Blood Transfusion Service
Ministry Of Health and Population
Tel : 2012 2174488
Fax : 202 7613124
E-Mail: faten@moftah.com


ERITREA
Mr. Asgedom Mosazghi Hagos
Medicines Control
Regulatory Services
Ministry of Health
T: 291 1 12 23 36
F: 291 1 12 28 99
E-mail: asgedom@eol.com.er


ETHIOPIA
Mr. Teferi Mengistab W.Aregay
Drug Control and Abuse Prevention
T: 251 1 52 41 18
F: 251 1 52 13 92
E-mail: mengisteab2000@yahoo.com


GAMBIA
Mr. Sillah Bubakar
Department of State for Health
T: 220 22 53 78
E-mail: bubakar-sillah@hotmail.com

Dr. Mariatou Tala Jallow
Medicines Board
Department of State for Health
T: 220 22 53 74
F: 220 22 58 73
E-mail: talacms@ganet.gm


GHANA
Mr. Emmanuel Kwabena Agyarko
Food and Drugs Board
T: 233 21 66 09 89
F: 233 21 66 03 89
E-mail: fdb@ghana.com

Mr. Michael F. Awuku-Kwatia
Pharmacy Council of Ghana
T: 233 21 678 538
F: 233 21 229 573
E-mail: pharmcon@gh.com

Mr. Ben Kwame Botwe
Drugs Division
Food and Drugs Board
T: 233 21 673 090
F: 233 21 660 389
E-mail: benbotwe@hotmail.com

Daniel George LUTTERODT
Food And Drugs Board, GHANA
Tel : 23321661248
Fax : 23321660389
E-Mail: fdb@ghana.com


GUINEA EQUATORIAL
Ms. Consuelo Ondo Efua
Aprovisionamiento de Medicamentos
T: 240 9213
F: 233 21 660 389
E-mail: decconsuelo@yyahoo.com

Mr. Tomás Mecha
Ministro Felegado
Mr. Ismael Mguema Esseng
Direccion General de Farmacia y Medicina
Tradicional
Ministry of Health
T: 240 91 196
F: 240 93 236


IVORY COAST
Gbonon Rosale ASSI
Ministry of Health
Tel : 22521357313
Fax : 22521356958
E-Mail: assirosalyn@yahoo.fr


KENYA
Ahmed Ibrahim MOHAMED
Pharmacy And Poisons Board
Tel : 254 20 271690506
Fax : 254 20 2722178
E-Mail: aimhussein@yahoo.com


LIBERIA
Mr. Tijli Tarty Tyee
Pharmacy Board of Liberia
T: 231 558097

LIBYAN ARAB JAMAHIRIYA
Marei E.F. MOHAMED
General Board of Health Care
Planning
Tel : 218 91 209 1041
Fax : 218 61 2239892
E-Mail: mareipharm@yahoo.com

Dr. Emhemmed Mohammed Khsheba
Narcotic & Psychotropics
Pharmaceutical & Medical Equipment Co.
T: 218 21 36 015 68
F: 218 21 36 015 86
E-mail: e.m.khsheba@yahoo.com


LESOTHO
Ms Nomaphuthi Hoohio
Pharmaceutical Services Department
Medicines Control Authority
T: 266 63 03 22 53
F:266 22 31 07 90
E-mail: pharmacy@lesotho.com

Ms Teboho Khetsi
Pharmaceutical Services Department
Medicines Control Authority
T: 266 58 84 32 35
F:266 22 31 07 90
E-mail: pharmacy@lesotho.com

Mr Matabele Sefali
Pharmaceutical Services Department
Medicines Control Authority
T: 266 58 86 81 6
F:266 22 70 13 40
E-mail: pharmacy@lesotho.com


MADAGASCAR
Mr. Jean René Randriasamimanana
Agence du Médicament
Ministère de la Santé
T: 26 12 022 365 22
F: 26 12 022 642 28
E-mail: agmed@simicro.mg


MALAWI
Mr. Patrick Simon Peter Tembo
Pharmacy, Medicines and Poisons Board
T: 265 01 755 634
F: 265 01 755 204
E-mail: admin@pmpb.malawi.net


MALI
Mr. Gaoussou Kanouté
Laboratoire national de la Santé
T: 223 222 4770
F: 223 223 2281
E-mail: lns@cefib.com

Minkaila Djibrilla MAIGA
Ministry Of Health Of Mali
Tel : 223 678 53 31
Fax : 223 223 24 63
E-Mail: mmaiga@dirpharma.org


MAURITIUS
Mr. Gerard Requin
Pharmaceutical Services
Pharmacy, Drug Regulation and Overall management
Ministry of Health and Quality of Life
T: 230 201 1334
F: 230 201 3891
E-mail: chpheist@intnet.mu


MOROCCO
Dr. Haouach Imane
National Laboratory for Drug Control-
Direction du Medicament et de la Pharmacie
T: 212 6369 9841
F: 212 3777 2520

Mohamed Abdelmoumen MAHLY
Ministry Of Health
Tel : 212 6181 0193
Fax : 212 3777 2833
E-Mail: mbouabdellah@menara.ma


MOZAMBIQUE
Mr. Joaquim Durao
Pharmaceutical Department
Ministry of Health
T: 258 1 32 6547
F: 258 1 303 473
E-mail: jdurao@tropical.co.mz

Dr. Alexandre Manguele
Directorate of Health
Ministry of Health
T: 258 82 303 360
F: 258 13 261 64
E-mail: misaudns@tropical.co.mz


NAMIBIA
Mr. Johannes Gaeseb
Health Care Services
Ministry of Health and Social Services
T: 264 61 203 23 50
F: 264 61 203 23 49
E-mail: regmeds@mhss.gov.na

Ms. Dinah Jorokee Thijo
Drug Control
Ministry of Health & Social Welfare
T: 264 61 203 23 91
F: 264 61 203 23 49
E-mail: regmeds@mhss.gov.na


NIGER
Dr. Sani Issa
Direction Générale de la Pharmacie
T: 227 97 48 67
F: 227 73 35 70
E-mail: dphl@intnet.ne


NIGERIA
Adeline I OSAKWE
National Agency for Food and Drug Administration and Control
Tel : 14521
E-Mail: sdnafolac@yahoo.com

Somoto Dorothy AKUNYILI
NAFDAC National Agency for Food & Drug
Tel : 2.3480696614e+012
E-Mail: somtois22@yahoo.fr

Joyce ELUWA
National Agency for Food and Drug Administration and Control
Tel : 2.3480576423e+012
Fax : 23495241461
E-Mail: joyceluwa29@yahoo.com

Dr. Dora Akunyili
National Agency for Food and Drug Administration and Control
T: 234 9 524 09 94
F: 234 9 524 09 94
E-mail: nafdac@yahoo.com

Ms Emem Etokebe
National Agency for Food and Drug Administration and Control
T: 234 9 524 09 94
F: 234 9 524 09 94
E-mail: nafdac@yahoo.com

Mr. Joseph Nwoye
National Agency for Food and Drug Administration and Control
T: 234 9 524 09 94
F: 234 9 524 09 94
E-mail: nafdac@yahoo.com

Mr. Declan Ugwu
National Agency for Food and Drug Administration and Control
T: 234 9 524 09 94
F: 234 9 524 09 94
E-mail: nafdac@yahoo.com


SIERRA LEONE
Michael Jack LANSANA
Pharmacy Board Of Sierra Leone
Tel : 232 22 229 346
Fax : 232 22 224 526
E-Mail: pharmbdsl@hotmail.com


SENEGAL
Dr. Rokhaya Ndiaye Kande
Direction de la Pharmacie et des Laboratoires
T: 822 4470


SOUTH AFRICA
Dr. Shabir Banoo
Medicines Control Council
Department of Health
T: 27 83 786 9854
F: 27 12 312 0214
E-mail: banoos@health.gov.za

Dr. Frank Hlangwane
Medicines Evaluation and Research
Department of Health
T: 27 12 312 0214
F: 27 12 312 3104
E-mail: kgatle@health.gov.za

Mandisa HELA
Department of Health
Tel : +12 312 0363/4
Fax : +12 312 3166
E-Mail: helam@health.gov.za

Anban PILLAY
Department Of Health
Tel : 27 82 4191925
Fax : 27 12 3120051
E-Mail: pillaa@health.gov.za


SOMALIA
Ahmed GULED
Ministry Of Health
Mohamed DUALE
Transitional Federal Govt. of SOMALIA
Tel : 002 54 7222 17350
E-Mail: mohamedduale32@yahoo.com


SUDAN
Tahani Abdel, Rahim AHMED
Federal Ministrey Of Health
Tel : 2.4918379334e+011
Fax : 2.4918377284e+011
E-Mail: tahani_gawish@yahoo.com

Salah Eldin JAWHER
Federal Ministry Of Health
Tel : 2.4918374926e+011
Fax : 2.4918377297e+011
E-Mail: salahjawher@hotmail.com


Mr. Salan Eldin Abdelrahman Abdel Aziz
General Directorate of Pharmacy
Federal Ministry of Health
T: 249 11 77 56 97
F: 249 11 77 29 70
E-mail: salahjawher@hotmail.com

Mr. Zain-Elaboin Mohamed
Department of Phamarcy
Federal Ministry of Health
T: 249 11 77 56 97
F: 249 11 77 29 70
E-mail: zainalfahal@hotmail.com


TUNISIA
Amor TOUMI
Laboratiore National De Control Des
Medicaments
Tel : 216 570117
Fax : 206 7 1571015
E-Mail: amos.toumi@rns.tn

Dalila DARGHOUTH
Ministry of Health
Tel : 216 71 796824
Fax : 216 71 797816
E-Mail: dalila.darghouth@rns.tn


UNITED REPUBLIC OF TANZANIA
Sikubwabo Sentoke NGENDABANKA
Tanzania Food and Drugs Authority
Tel : 255 22 2450751
Fax : 255 22 2450793
E-Mail: ssngenda@yahoo.co.uk

Ollympia KOWERO
Tanzania Food and Drugs Authority
Tel : 255 22 2450751
Fax : 255 22 2450793
E-Mail: ollympiak@yahoo.com

Emmanuel ALPHONCE
Tanzania Food and Drugs Authority
Tel : 255 22 2450751
Fax : 255 22 2450793
E-Mail: emmaa_25551@yahoo.com

Margareth Ndomondo SIGONDA
Tanzania Food and Drugs Authority (TFDA)
Tel : 255 22 2450751
Fax : 255 22 2450793
E-Mail: mnsigonda@yahoo.co.uk

Dr. Nditonda Benno Chukilizo
Drug Registration
Product Evaluation and Registration
Tanzania Food and Drug Authority
T: 255 22 2450 512
F: 255 22 2450 793
E-mail: nchukilizo@yahoo.com

Mr. Henry Irunde
Public Education and Information
Tanzania Food and Drug Authority
T: 255 22 2450 751
F: 255 22 2450 793
E-mail: tfda@simbanet.net

Mr. Erasto Sokia Theobadi Mosha
Drug Inspection
Tanzania Food and Drug Authority
T: 255 22 2450 512
F: 255 22 2450 793
E-mail: tfda@simbanet.net

Ms. Zera Msuya
Quality Control Laboratory
Tanzania Food and Drug Authority
T: 255 22 2450 751
F: 255 22 2450 793
E-mail: zmmsuya@yahoo.com

Mr. Joseph Salinga Muhume
Ministry of Health
T: 255 22 21 20 261
F: 255 22 2450 793
E-mail: tfda@simbanet.net

Dr. Leonard Gabriel Upunda
Ministry of Health
T: 255 22 21 20 261
F: 255 22 2450 793
E-mail: tfda@simbanet.net


TOGO
Mr. Nyansa
Direction Generale de la Santé Publique
T: 228 22 07 99


TUNISIA
Ms. Dalila Darghouth
Pharmaceutical Inspection
Ministry of Health
T: 216 71 560 444
F: 216 71 573 023
E-mail: dalila.daghouth@RNS.TN

Pr. Amour Toumi
Direction de la Pharmacie et du Médicament
Ministère de la Santé Publique
T: 216 71 79 68 24
F: 216 71 79 78 16
E-mail: amor.toumi@rns.tn


UGANDA
Mr. Gabriel Kayanja Kaddu
National Drug Authority
T: 256 41 34 73 91
F: 256 41 25 57 58
E-mail: ndaug@nda.or.ug

Dr. James Makumbi
National Drug Authority
T: 256 41 34 73 91
F: 256 41 25 57 58
E-mail: ndaug@nda.or.ug

Mr. Apollo Edson Muhairwe
National Drug Authority
T: 256 41 34 73 91
F: 256 41 25 57 58
E-mail: ndaug@nda.or.ug

Jack G. M. JAGWE
Hospice Africa Uganda
Tel : 256 41 266867
Fax : 256 41 510087
E-Mail: jjagwe@hospiceafrica.or.ug

Deus MUBANGIZI
National Drug Authority
Tel : 256 41 347391
Fax : 256 41 255758
E-Mail: deuskm@yahoo.co.uk


ZIMBABWE
Mafios DAURAMANZI
Medicines Control Authority Of
Zimbabwe
Tel : 263 4 736 981-5
Fax : 263 4 736 980
E-Mail: mcaz@africaonline.co.zw

Emma MUDZURA
Medicines Control Authority Of
Zimbabwe
Tel : 263 4 736981 5
Fax : 263 4 736 980
E-Mail: mcaz@africaonline.co.zw

Dr. Mafios Dauramanzi
Medicines Control Authority of Zimbawe
T: 263 4 736 981
F: 263 4 736 980
E-mail: mcaz@africaonline.co.zw

Mr. Rutendo Kuwana
Medicines Control (Licensing Unit)
T: 263 4 736 981
F: 263 4 736 980
E-mail: mcaz@africaonline.co.zw

Dr. Gugu Nolwandle Mahlangu
Medicines Control
T: 263 4 736 981 F: 263 4 736 980
E-mail: mcaz@africaonline.co.zw

Dr. Mabel Torongo
Medicines Control Authority of Zimbawe
T: 263 4 736 981
F: 263 4 736 980
E-mail: mcaz@africaonline.co.zw


WORLD HEALTH ORGANIZATION
Regional Office- Africa
Dr. Ossy M.J. Kassilo
Traditional Medicine
Essential Drugs and Medicines Policy
T: 47 241 39 268
F: 47 241 39 511
E-mail: kasiloo@afro.who.int

International Regulatory Affairs Focus-Intellectual Property Laws

International Regulatory Affairs Focus: Cell-Based Viral Vaccies
FDA Issues Guidance to Industry for Development of Cell-Based Viral Vaccines. Technology for New-Generation Vaccines for Viral Infectious Diseases. FDA New Release.
28 September 2006. Posted on IRAUP.Com Website 28 September 2006


A copy of the guidance, "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases," is available

International Regulatory Affairs Focus-Electronic Submissions Gateway

International Regulatory Affairs Focus: High-Strength Hydrogen Peroxide
FDA MedWatch - High-Strength Hydrogen Peroxide: an unapproved product - consumers warned not to purchase or use. 27 July 2006. Date Posted: 08 August 2006

FDA warned consumers not to purchase or to use high-strength hydrogen peroxide products, including a product marketed as "35 Percent Food Grade Hydrogen Peroxide".

International Regulatory Affairs Focus-Electronic Submissions
Guidance for Industry: Electronic Submissions. Revision 1; 19 April 2006 Posted on IRAUP.Com Website 19 July 2006

Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications

International Regulatory Affairs Focus
Advice for Patients With Soft Contact Lenses: US FDA 21 April 2006

New Information on Risk of Serious Fungal Infection

International Regulatory Affairs Updates-Avian influenza Regulatory focus
Avian influenza Regulatory alert- 20 January 2006 ConsumerAffairs.com; 14 December 2005 FDA Warns of Phony Bird Flu Drugs

International Regulatory Affairs Updates-Avian influenza Regulatory focus

International Regulatory Affairs Focus: Anti-counterfeit Drugs
Anti-Counterfeit Drugs Efforts
07 January 2006; TheDay.com News; By ANTHONY CRONIN
Day Staff Writer, Business
Published on 1/7/2006

Pfizer Combats Knockoff Drugs With Technology; Drugmaker first in industry to put ID tags on packaging

International Regulatory Affairs Focus: Product Recall
FDA STATEMENT December 30, 2005
Media Inquiries: Rae Jones, 301-827-6242
Consumer Inquiries: 888-INFO-FDA. See also FDA Recall-- Firm Press Release dated 20 December 2005 and Posted: 30 December 2005 Dog Food Contaminated with Potent Aflatoxin

Diamond Pet Food Recalled Due to Aflatoxin. The Food and Drug Administration (FDA) is conducting an investigation into the deaths and illnesses of dogs that consumed pet food contaminated with a potent toxin called aflatoxin. To date, FDA is aware of 23 dogs that have died and another 18 dogs that have become ill. The pet food is made by Diamond Pet Food at its Gaston, South Carolina facility.

Customers who have purchased the recalled Diamond Pet Food manufactured in the South Carolina plant should immediately stop using it and return any remaining product to their retailer.

FDA also has discovered that some of the recalled product was exported to at least 29 countries, including countries within the European Union.

International Regulatory Affairs Focus: Regulation of Agbiotech in Vietnam

International Regulatory Affairs Focus: Avian influenza casualties in China

International Regulatory Affairs Focus: China and Avian flu vaccine
WHO official recently urged China to share more information on avian influenza outbreaks

Dec 27, 2005 (CIDRAP News)

China urged to share bird flu data, country claims better antiviral and avian vaccine

International Regulatory Affairs Focus: WHO: Tamiflu Resistance

International Regulatory Affairs Focus: PAHO on Avian influenza

International Regulatory Affairs Focus: AIDS Treatment Success Story

International Regulatory Affairs Focus: US Avian flu Resource
Updated information on Pandemic flu (H5N1) and Avian influenza

The official U.S. government Web site for information on pandemic flu and avian influenza.

International Regulatory Affairs Focus: Avian influenza H5N1
News and information on H5N1 Avian influenza virus

Latest News on Avian influenza H5N1 pandemic

International Regulatory Affairs Focus: New EMEA Legislation

International Regulatory Affairs Focus: West Nile Virus Screening
FDA News 01 December 2005 First Test to Screen for West Nile Virus

FDA Approves First Test to Screen for West Nile Virus in Donors of Blood, Organs, Cells and Tissues

International Regulatory Affairs Focus: Pharmacovigilance
Guidance Documents related to electronic transmission of ICSRs

EMEA; Posted on IRAUP website: 06 December 2005 The EMEA has announced that effective 20 November 2005, all adverse event reporting must be done electronically.

International Regulatory Affairs Focus: Tanzania monitoring bird flu
Special Means of Monitoring bird flu in Tanzania Monitoring Bird Migration in Tanzania People's Daily Online; 26 Nov 2005

International Regulatory Affairs Focus: Avian influenza Human Infection
Indonesia reports another case of bird flu transmission to Human Indonesia Reports 12th Human Case of Bird Flu; VOA News; 26 November 2005

International Regulatory Affairs Focus:
Antibiotic Resistance Surveillance in Veterinary Medicines in the EU.

Source: CVMP general guidance of the EMEA; Date: 17 November 2005;
Report and Qualitative Risk Assessment of Antibiotic Resistance

International Regulatory Affairs Focus:
Africa and the Avian Influenza Threat; Source: Datelinehealth-Africa (DLHA)News; 17 November 2005 Africa and Avian Influenza Outbreak: Epidemiology and Containment Preparedness

International Regulatory Affairs Focus:
A Perspective on Africa's Preparedness for an Avian Influenza Pandemic

Date: 24 October, 2005
Solomon K. Sackitey
http://www.iraup.com/index.php
E-mail: info@iraup.com
Date Posted on the Web: 04 November 2005

Introduction


As the world prepares to face the threat of pandemics of the Highly Pathogenic Avian Influenza virus subtype H5N1, it is pertinent to ask "How is Africa preparing for this concern?"


The World Health Organization (WHO) (1) states that "Avian influenza or "bird flu", is a contagious disease of animals caused by viruses that normally infect only birds and less commonly pigs. Avian influenza viruses are highly species-specific, but have on rare occasions, crossed the species barrier to infect humans(1)".


The symptoms of bird flu are similar to those of the common flu and are characterized by fever, cough and muscle aches. Aside from these, bird flu patients endure sore throat, viral pneumonia, multiple organ failure, especially in the lungs and kidneys, and other severe and life-threatening complications in a matter of days (2).

Avian influenza transmissions from animals to humans have been documented since 1997 (3), (4). Three worldwide avian influenza pandemics recorded during the 20th Century are; The "Spanish flu” of 1918-19 in which an estimated 50 million people died worldwide, the "Asian flu" of 1957-58, where about 70,000 deaths were reported in the United States of America and the " Hong Kong flu," of 1968-69 resulted in about 34,000 deaths in the United States of America (5).


The US Centers for Disease Control and Prevention (CDC) reported that the infections during the Asian flu and the Hong Kong flu pandemics were caused by viruses containing a combination of genes from a human influenza virus and an avian influenza virus.The 1918-19 pandemic virus appeared to have an avian origin (4). The morphology and genetics of the Avian influenza virus (H5N1) have been reported by Padhi et. al. (6).

The goals of this report are to create increased awareness of the “avian flu” as a potential public health problem of significance to Africa and provide information regarding approved Avian influenza medical products (7). Besides, attention is directed to where in Africa one could go for help in preparation for the threat of pandemic bird flu (8, 9, 10). Finally, one major focus of this report is to caution consumers, manufacturers and vendors alike about future treatment and vaccination programs regarding the use of counterfeit and adulterated Avian influenza medical products. The counterfeit drugs (11) business is a multibillion dollar industry which is becoming an immense health and regulatory problem not only in the industrialized world but in the poor countries of the developing world including Africa.


Epidemiology

As at date, the Asian bird flu which had its origin in Asia (Cambodia, China, Indonesia, Japan, Laos, South Korea, Thailand and Vietnam) in the latter part of 2003 and going into early 2004 (12), has migrated to Europe (Britain, Romania and Turkey, in particular). These European countries are within close proximity of countries in the Middle East, North, West, Central and East Africa regions. To date, no human cases of Asian bird flu has been reported in any African country. It is worth noting also that no cases of the Asian bird flu (H5N1) have been reported in birds in any African country. Although cases of highly pathogenic avian influenza (HPAI) subtype H5N2 have been confirmed in ostriches in South Africa in August 2004 (13), this is different from the H5N1 HPAI subtype that is causing a global panic since its detection in Asia. Notwithstanding, there is good cause for major concern for the Avian flu in Africa. Once the bird flu makes its way from any European country to a Euro-proximate region of Africa, chances are very high that this could spread rapidly to the rest of Africa in view of the fact that there are ample open market poultry vendors. This concern has been highlighted by the United Nations Food and Agriculture Organization (FAO) (14).


If not safeguarded aggressively, the bird flu could cause a major devastating blow to Africa’s economy which is already being threatened by the AIDS epidemic. It is estimated, for example, that the Common Market for Eastern and Southern Africa (COMESA) alone has a total Gross Domestic Product (GDP) of over US$203 billion (15).


Diagnostic testing methods


Avian influenza testing methods recommended by the CDC have been published in February 2004 and in August 2004. Three identification procedures routinely used in the laboratory involve culturing or growing the clinical specimens under Biosafety Level 3 (BSL 3) conditions, the Polymerase Chain Reaction (PCR) and the Commercial Antigen Method. The BSL 3 conditions are laboratory conditions which are optimized to contain the causal organisms without escaping into the environment. PCR methods result in the exponential amplification of genes while Commercial Antigen testings involve the detection of the gene products or proteins (16).


Approved Avian Influenza Medicines


Medical products approved by the US Food and Drug Administration (FDA) for the treatment and/or prevention of influenza A viruses (7) are amantadine (trade name: Symmetrel), rimantadine (trade name: Flumadine), oseltamivir (trade name:Tamiflu), and zanamivir (trade name: Relenza). Tamiflu and Relenza are approved for the treatment of acute uncomplicated illness due to influenza A and B. Tamiflu has been approved also for preventive use while Relenza is approved only for treatment. Symmetrel and Flumadine are approved for treatment and prevention of influenza A. A precautionary note to consumers is that “the drugs may not always work because influenza virus strains can become resistant to one or more of these medications. For example, the influenza A (H5N1) viruses identified in human in Asia in 2004 and 2005 have been resistant to amantadine and rimantadine”, the FDA reported (7). At the moment, there is no H5N1 (bird flu) vaccine (17) despite the fact that aggressive Research efforts have been under way.



Structures and Strategies needed to combat Avian flu in Africa


• Personnel, Monitoring and Control


A consortium of African Health Ministers, Regulatory Affairs and Veterinary Services personnel would need to immediately come up with strategies for monitoring the flight of birds from Europe into the Middle East and the north-eastern quadrant of Africa. Besides, this consortium would need to undertake surveillance measures on wild and domestic birds and ban the importation of birds into African countries. A strategy for eliminating the influx of counterfeit avian flu drugs and vaccines into the continent will be worthwhile.


• Training and Communications

African Health Ministers and Regulatory Affairs personnel need to be active participants at international conferences such as the “Preparation of the Joint WHO/OIE/FAO/World Bank Conference to Mobilize Resources for Control of Avian Influenza in Animals and for Prevention of Pandemic Influenza in Humans” to be held in Geneva, Switzerland (18).

Additionally, recommended strategies for combating the global threat of Avian Influenza virus (H5N1) (19) and for the Progressive Control of Highly Pathogenic Avian Influenza (HPAI) have been provided (20).

Alert messages including high mortality rates among birds and epidemiological events should be posted regularly on websites for Regional, National Health, Regulatory Affairs bodies and Selected Regional Harmonizations in Africa . Other notifications should include quarantine and movement control inside the various countries in Africa.


• Current state of preparedness

A few African countries including Ghana, Tanzania, Congo, Sudan, Senegal, Uganda, Kenya and South Africa (23, 24) have already embarked on various measures in an effort to curb this disease, should it become a health problem. These measures primarily involve banning the importation of poultry and poultry products from known areas of bird flu cases. However, banning imports is not enough. More efforts are needed. Such efforts would include random testing of birds from various farms and uncontrolled (open market) vendors in various locales. Moreover, aggressive efforts need to be embarked upon to see if the bird flu is already on the continent.


• Learning from South Africa and Senegal:


South Africa’s Minister of Agriculture and Land Affairs, Ms. Thoko Didiza, has announced the slaughtering of nearly 6,000 ostriches to contain an outbreak of the bird flu. On 13 September 2005 (24), the Minister also declared that the country is now free of the disease. The steps this country has taken to free it from notifiable Avian Influenza under the guidelines of the International Organization for Animal Health (OIE) (8) has recently been reported by the Minister (24). These steps include monitoring of migrating shore birds, testing of birds to be imported at sites of origin, quarantined and retested in South Africa and the inactivation of the virus prior to the importation of other poultry products. Other birds included in these strategies are turkey, ducks and chicken.


Senegal’s strategies include not only banning the importation of birds but also measures such as the immediate inspection of all poultry stocks by the Veterinarian and the containment and inspection of any dead bird (23).


• A Call for Emergency Meetings


This is urgently needed to formulate strategies aimed at combating the Avian flu in Africa from the African’s perspectives. Among the justification for this meeting is the fact that Africans are more conversant with the infrastructure of Africa especially when it comes to efforts to disseminate information into the remote areas of various African countries. Such meetings would be better served within the context of The Common Market for Eastern and Southern Africa, The African Union, West African Health Organization and the Southern African Development Community (21, 22), among others.


The justification for the proposed emergency meeting stated above should not be misinterpreted to mean that Africa’s problems should only be solved by Africans. Africa is not in isolation in the community of nations but it must be a major player in developing strategies for curbing this global health threat in the continent.



• Funding

An emergency funding and strategic planning for tackling the Avian flu in Africa should engage the participation of The African Development Bank (ADB), The African Union (AU), The World Bank, The World Health Organization (WHO), The Food and Agriculture Organization of the United Nations (FAO), The World Organisation for Animal Health (OIE), The United States of America (25) and other international organizations.


• Treatment/Vaccination control


In order to ensure that counterfeit or adulterated Avian influenza drugs and vaccines are not prevalent on the African markets, African National and Regional Regulatory bodies (26), in addition to the WHO and the OIE, among others, need to be vigilant. This vigilance would include ways and means of setting up mobile laboratories (27) and standard laboratories capable of testing drugs and vaccines coming into the various countries.


Conclusions


For Africa’s preparedness to combat the threat of Avian influenza, the following are recommended:


Increased awareness, training and technology opportunities within Africa and in collaboration with foreign counterparts and the availability of financial resources. In addition, the formation of an African Harmonization Union of Health Regulators drawn from Academia, Government Agencies, Non-governmental agencies, the Food and Agriculture sector and the Traditional and Herbal Medicines groups would be very beneficial. Such a Union should have very close interactions with various organizations (28) such as the Human and Veterinary International Conference of Harmonizations (ICH and VICH) respectively. Other established Unions or organizations include the European Medicines Agency (EMEA), The US Food and Drugs Administration (FDA), The Pan American Health Organization (PAHO), the Pan American Network for the Drug Regulatory Harmonization (PANDRH), the Therapeutic Goods Administration (TGA), the US Department of Agriculture (USDA) and the International Federation of Pharmaceutical Manufactures Association (IFPMA).


In the Global Economy, every country is a major player irrespective of size or location. For this reason and for a health concern of the magnitude feared, an international effort is envisaged. Emerging markets in Africa and the rest of the developing world are needed for the prosperity of industrialized countries. At the same time, the development of these markets has to be influenced by the industrialized countries.


In order to adequately prepare to fight off any pandemic threat, strategies for minimizing the influx of counterfeit drugs and vaccines on the global market must be given a serious consideration.


Resources:

(1) What is Avian influenza virus?
http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/index.html#whatis
http://www.who.int/csr/disease/avian_influenza/avian_faqs/en/index.html

(2) Avian influenza symptoms
http://www.msnbc.msn.com/id/6880869/

(3) Avian Influenza Infection in Humans
http://www.cdc.gov/flu/avian/gen-info/avian-flu-humans.htm

(4) Transmission of Influenza A Viruses Between Animals and People
http://www.cdc.gov/flu/avian/gen-info/transmission.htm

(5) Influenza Pandemics during the 20th Century
http://www.cdc.gov/flu/avian/gen-info/pandemics.htm

(6) Morphology of influenza A (H5N1)
Padhi S, Panigrahi PK, Mahapatra A, Mahapatra S (2004): Avian influenza a (H5N1): A preliminary review; Indian Journal of Medical Microbiology (Vol. 22 Issue # 3; pages 143-146)
Department of Microbiology, MKCG Medical College, Berhampur, Orissa - 760 004, India
http://www.ijmm.org/viewimage.asp?img=IndianJMedMicrobiol_2004_22_3_143_11206_1.jpg


(7) Approved Avian Flu Drugs
http://www.fda.gov/cder/drug/antivirals/influenza/default.htm


(8) Guidelines of the International Organization for Animal Health (OIE)
http://www.oie.int/downld/Prep_conf_Avian_inf/Terrestrial%20Code/Terrestrial%20Code_guidelines%20for%20the%20surveillance%20AI.pdf


(9) WHO National Influenza Centers In Africa
http://www.who.int/csr/disease/influenza/centres/en/index.html


Algeria - Algiers
Dr Belabbes Hadj
Institut Pasteur d'Algérie
Annexe de Sidi Fredj
Rue Docteur Laveran
Hamma Arger
Algiers
Algeria
Tel: +213 (21) 376850
Fax: +213 (21) 390257
Email: hbelabbes@sante.dz


Central African Republic - Bangui
Dr Antoine Talarmin
Institute Pasteur de Bangui
BP 923
Bangui
Central African Republic
Tel: +236 (61) 2837
Fax: +236 (61) 01 09
Email: talarmin@intnet.cf


Egypt - Cairo
Dr Mostafa Orkhan
Egyptian Organisation for Biological Products and Vaccines
51, Wezarat El Zeraa
Agouza, Dokki
Cairo
Egypt
Tel: +20 (2) 7611111 - ext. 3394
Fax: +20 (2) 761 8497
Email: morkhanh@link.net


Kenya - Nairobi
Dr F. Okoth
Center for Virus Research
P.O. 54628
Nairobi
Kenya
Tel: +254 (2) 722 541
Fax: +254 (2) 726 115
Email: kemriub@ken.wuthnet.org


Madagascar - Antananarivo
Dr Dominique Rousset
WHO National Centre for Influenza
Unité de Virologie - Institut Pasteur de Madagascar
BP 1274, Antananarivo 101
Madagascar
Tel: +261 (20) 224 1272
Fax: +261 (20) 224 1534
Email: drousset@pasteur.mg


Morocco - Rabat
Dr Rajae Aouad
Labourtore d'Immunologie - Virologie
27 Avenue ibn Batouta
B.P. 769
Rabat
Morocco
Tel: +212 (37) 771 930
Fax: +212 (37) 772 067
Email: RELAOUAD@sante.go.ma


Nigeria - Ibadan
Dr D. Olaleye
College of Medicine
University of Ibadan
U.C.H.
Ibadan
Nigeria
Tel: +234 (02) 241 00 88 ext. 2796 / 2662
Fax: +234 (02) 241 1768 (college) 241 3545 (UCH)
Email: library@odeku.med.ui.edu.ng


Senegal - Dakar
Dr Mbayame Niang
Department of Virology, Pasteur Institute
BP 220 Dakar
Senegal
Tel: +221 (839) 9222
Fax: +221 (839) 9210
Email: niang@pasteur.sn


South Africa - Sandringham
Dr Terry Besselaar
National Institute for Communicable Diseases
Private Bag X4
Sandringham 2131
South Africa
Tel: 27 11 386 6354
Fax: +27 (11) 386 6455
Email: terryb@nicd.ac.za
Website: http://www.niv.ac.za


South Africa - Capetown
Dr Girish Kotwal
University of Cape Town Medical School Observatory
Medical Microbiology
Capetown
South Africa
Tel: +27 (21) 406 6128
Fax: +27 (21) 448 4110
Email: gkotwal@curie.uct.ac.za


Sudan - Khartoum
Dr A.R. Salim
University of Khartoum
Department of Microbiology and Parasitology
P.O. Box 102
Khartoum
Sudan


Tunisia - Tunis
Dr Amine Slim
Laboratoire de Microbiologie
c/o M. le Directeur
Hôpital Charles Nicolle
Bvd 9 avril
Tunis
Tunisia
Tel: +216 (71) 578186
Fax: +216 (71) 56 87 44
Email: amislim@yahoo.com


Uganda - Entebbe
Dr S.D.K. Sempala
Uganda Virus Research Institute
P.O. Box 49
Entebbe
Uganda


(10) Selected African Countries that are OIE Member states and Official Delegates:
http://www.oie.int/eng/OIE/PM/en_PM.htm


GHANA
Dr Mensah Agyen-Frempong
Acting Director
Veterinary Services Department
Ministry of Food and Agriculture
PO Box M 161
Accra


TANZANIA
Dr Johnson O. Mollel
Acting Director of Veterinary Services
Ministry of Water and Livestock Development
Temekeveterinary
PO Box 9153
Dar Es Salaam

NIGERIA
Dr Foluso Emman Fasanmi
Director
Dept. of Livestock and Pest Control Services
Federal Ministry of Agriculture and
Rural Development
New Secretariat, Area 11
P.M.B. No. 135
Garki, Abuja, FCT


KENYA
Dr Truphosa A. Otindo
Director Ag. of Veterinary Services
Department of Veterinary Services
Ministry of Agriculture and Rural Development
Veterinary Research Laboratory
P.O. Kabete, Nairobi


ZIMBABWE
Dr Stuart K. Hargreaves
Principal Director
Division of Livestock and Veterinary Services
Ministry of Agriculture and Rural Development
18 Borrowdale Road
PO Box CY66
Causeway Harare


SOMALIA
Dr Ahmed Mohamed Hashi
General Manager
Somali Livestock Marketing Authority (SOLMA)
Hargeisa


SOUTH AFRICA
Dr Emily Mmamakgaba Mogajane
Assistant Director General
National Regulatory Services
Department of Agriculture
Private Bag X250
Pretoria, 0001


ETHIOPIA
Dr Sileshi Zewdie
Head of Veterinary Services
Ministry of Agriculture, Animal and
Fisheries Resources
Development and Regulatory Department
PO Box 62347
Addis Ababa


(11) Counterfeit Drugs
http://www.ucsfhealth.org/childrens/health_library/reuters/2005/08/20050801elin017.html
http://www.fda.gov/oc/initiatives/counterfeit/report02_04.html
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-13-2005/0004105990&EDATE=
http://www.washingtonpost.com/wp-dyn/articles/A26552-2005Apr4.html
http://www.newsmax.com/archives/articles/2005/9/19/161739.shtml


(12) CDC: Avian Influenza (Bird Flu)
http://www.cdc.gov/flu/avian/

(13) Highly Pathogenic Avian Influenza, South Africa
http://www.aphis.usda.gov/vs/ceah/cei/IW_2004_files/hpai_southafrica_08112004/HPAI_SOAFRICA_08062004.htm


(14) Africa may face serious bird flu risk
http://www.fao.org/newsroom/en/news/2005/108212/


(15) The Common Market for Eastern and Southern Africa (COMESA)
http://www.comesa.int/index_html/view


(16) Avian influenza testing methods
http://www.cdc.gov/flu/avian/professional/han081304.htm
http://www.cdc.gov/flu/professionals/labdiagnosis.htm#lab

(17) Avian Influenza Vaccines
http://www.cdc.gov/flu/avian/gen-info/vaccines.htm


(18) “Preparation of the Joint WHO/OIE/FAO/World Bank Conference to Mobilize Resources for Control of Avian Influenza in Animals and for Prevention of Pandemic Influenza in Humans” to be held in Geneva (Switzerland), 7-9 November 2005
http://www.oie.int/eng/manifestations/en_prep_manif_IA.htm.


(19) WHO Recommended Strategic Actions for Responding to the Avian Influenza Pandemic Threat
http://www.who.int/csr/resources/publications/influenza/WHO_CDS_CSR_GIP_05_8-EN.pdf


(20) Global Strategy for the Progressive Control of Highly Pathogenic Avian Influenza (HPAI)
http://www.fao.org/ag/againfo/resources/documents/empres/AI_globalstrategy.pdf


(21) Selected Regional Harmonizations in Africa: http://www.iraup.com/results.php?page_name=reg_harm
http://www.iraup.com/index.php


(22) Selected Regulatory Bodies in Africa
http://www.iraup.com/results.php?page_name=regions_africa


(23) African countries act on bird flu
http://news.bbc.co.uk/2/hi/africa/4363256.stm
http://www.eastandard.net/hm_news/news.php?articleid=30906


(24) South Africa determined to stay bird flu free
http://www.safrica.info/public_services/citizens/health/aviianflu2110.htm


(25) Bush Outlines $7.1B Flu-Fighting Strategy
By LAURAN NEERGAARD, AP Medical Writer /Yahoo News
http://news.yahoo.com/s/ap/20051101/ap_on_he_me/bush_flu_16;_ylt=AtjAVdPH3kFy3MP9PPE1826EBMoA;_ylu=X3oDMTBiMW04NW9mBHNlYwMlJVRPUCUl

(26) Selected National Regulatory Affairs Bodies


Ghana:
(i) Ghana Food and Drugs Board:
http://www.fdbghana.gov.gh/
(a) Phone: 233-21-660 989 FAX: 233-21-660-389
E-mail: fdb@ghang.com
(b) Phone: 233-21-673 090 (Drugs Division)

(ii) Pharmacy Council of Ghana
Phone: 233-21-678-538 Fax: 233-21-229-573
E-mail: Pharmcon@gh.com


Nigeria:
(i) The National Agency for Food, Drug Administration and Control http://www.nafdacnigeria.org


(27) Mobile Labs:
The GPHF-Minilab® - Protection Against Counterfeited and Substandard Pharmaceuticals
http://www.gphf.org/web_en/projekte/minilab/index.htm


(28) International Harmonizations

ICH:http://www.ich.org/cache/compo/276-254-1.html

EMEA:http://www.emea.eu.int/index/indexv1.htm

PAHO:http://www.paho.org/english/GOV/govbodies-index.htm

PANDRH:http://www.paho.org/english/ad/ths/ev/RedParf-home.htm

FDA: http://www.fda.gov

TGA: http://www.tga.gov.au/

VICH: http://vich.eudra.org/

IFPMA: http://www.ifpma.org/

Solomon Sackitey is a Senior Regulatory Affairs Specialist at a Global Animal Health Corporation. He also has experience in HIV/AIDS Vaccines Research at a Global Pharmaceutical Company and can be reached at Email: info@iraup.com. This story is not written on behalf of these Corporations nor does it imply sponsorship by them. Organizations/Companies and products/resources mentioned in this story are by no means endorsements.

International Regulatory Affairs Focus:
WHO National Avian Influenza Centers in Africa

Source:
http://www.who.int/csr/disease/influenza/centres/en/index.html

Date posted on the Web: 04 November 2005

The World Health Organization (WHO) has provided a list of National Centers for Avian Influenza in various parts of the world in preparation for a possible global bird flu pandemic. Below are selected National Avian influenza centers in Africa:


Algeria - Algiers
Dr Belabbes Hadj
Institut Pasteur d'Algérie
Annexe de Sidi Fredj
Rue Docteur Laveran
Hamma Arger
Algiers
Algeria
Tel: +213 (21) 376850
Fax: +213 (21) 390257
Email: hbelabbes@sante.dz


Central African Republic - Bangui
Dr Antoine Talarmin
Institute Pasteur de Bangui
BP 923
Bangui
Central African Republic
Tel: +236 (61) 2837
Fax: +236 (61) 01 09
Email: talarmin@intnet.cf


Egypt - Cairo
Dr Mostafa Orkhan
Egyptian Organisation for Biological Products and Vaccines
51, Wezarat El Zeraa
Agouza, Dokki
Cairo
Egypt
Tel: +20 (2) 7611111 - ext. 3394
Fax: +20 (2) 761 8497
Email: morkhanh@link.net


Kenya - Nairobi
Dr F. Okoth
Center for Virus Research
P.O. 54628
Nairobi
Kenya
Tel: +254 (2) 722 541
Fax: +254 (2) 726 115
Email: kemriub@ken.wuthnet.org


Madagascar - Antananarivo
Dr Dominique Rousset
WHO National Centre for Influenza
Unité de Virologie - Institut Pasteur de Madagascar
BP 1274, Antananarivo 101
Madagascar
Tel: +261 (20) 224 1272
Fax: +261 (20) 224 1534
Email: drousset@pasteur.mg


Morocco - Rabat
Dr Rajae Aouad
Labourtore d'Immunologie - Virologie
27 Avenue ibn Batouta
B.P. 769
Rabat
Morocco
Tel: +212 (37) 771 930
Fax: +212 (37) 772 067
Email: RELAOUAD@sante.go.ma


Nigeria - Ibadan
Dr D. Olaleye
College of Medicine
University of Ibadan
U.C.H.
Ibadan
Nigeria
Tel: +234 (02) 241 00 88 ext. 2796 / 2662
Fax: +234 (02) 241 1768 (college) 241 3545 (UCH)
Email: library@odeku.med.ui.edu.ng


Senegal - Dakar
Dr Mbayame Niang
Department of Virology, Pasteur Institute
BP 220 Dakar
Senegal
Tel: +221 (839) 9222
Fax: +221 (839) 9210
Email: niang@pasteur.sn


South Africa - Sandringham
Dr Terry Besselaar
National Institute for Communicable Diseases
Private Bag X4
Sandringham 2131
South Africa
Tel: 27 11 386 6354
Fax: +27 (11) 386 6455
Email: terryb@nicd.ac.za
Website: http://www.niv.ac.za


South Africa - Capetown
Dr Girish Kotwal
University of Cape Town Medical School Observatory
Medical Microbiology
Capetown
South Africa
Tel: +27 (21) 406 6128
Fax: +27 (21) 448 4110
Email: gkotwal@curie.uct.ac.za


Sudan - Khartoum
Dr A.R. Salim
University of Khartoum
Department of Microbiology and Parasitology
P.O. Box 102
Khartoum
Sudan


Tunisia - Tunis
Dr Amine Slim
Laboratoire de Microbiologie
c/o M. le Directeur
Hôpital Charles Nicolle
Bvd 9 avril
Tunis
Tunisia
Tel: +216 (71) 578186
Fax: +216 (71) 56 87 44
Email: amislim@yahoo.com


Uganda - Entebbe
Dr S.D.K. Sempala
Uganda Virus Research Institute
P.O. Box 49
Entebbe
Uganda



International Regulatory Affairs Focus:
Selected World Organisation for Animal Health (OIE) Delegates/Member States from Africa

Date posted on the Web: 04 November 2005

Source:
http://www.oie.int/eng/OIE/PM/en_PM.htm

The OIE has published guidelines for Avian Influenza ("bird flu") surveillance at
http://www.oie.int/downld/Prep_conf_Avian_inf/Terrestrial%20Code/Terrestrial%20Code_guidelines%20for%20the%20surveillance%20AI.pdf

In preparation for the threat of Avian Influenza virus, subtype H5N1 ("bird flu") in Africa, these OIE delegates/members could provide very valuable information to country-specific or regional health authorities:


ETHIOPIA
Dr Sileshi Zewdie
Head of Veterinary Services
Ministry of Agriculture, Animal and
Fisheries Resources
Development and Regulatory Department
PO Box 62347
Addis Ababa



GHANA
Dr Mensah Agyen-Frempong
Acting Director
Veterinary Services Department
Ministry of Food and Agriculture
PO Box M 161
Accra



KENYA
Dr Truphosa A. Otindo
Director Ag. of Veterinary Services
Department of Veterinary Services
Ministry of Agriculture and Rural Development
Veterinary Research Laboratory
P.O. Kabete, Nairobi


NIGERIA
Dr Foluso Emman Fasanmi
Director
Dept. of Livestock and Pest Control Services
Federal Ministry of Agriculture and
Rural Development
New Secretariat, Area 11
P.M.B. No. 135
Garki, Abuja, FCT


SOMALIA
Dr Ahmed Mohamed Hashi
General Manager
Somali Livestock Marketing Authority (SOLMA)
Hargeisa


SOUTH AFRICA
Dr Emily Mmamakgaba Mogajane
Assistant Director General
National Regulatory Services
Department of Agriculture
Private Bag X250
Pretoria, 0001


TANZANIA
Dr Johnson O. Mollel
Acting Director of Veterinary Services
Ministry of Water and Livestock Development
Temekeveterinary
PO Box 9153
Dar Es Salaam


ZIMBABWE
Dr Stuart K. Hargreaves
Principal Director
Division of Livestock and Veterinary Services
Ministry of Agriculture and Rural Development
18 Borrowdale Road
PO Box CY66
Causeway Harare

IRA Focus: Drug Regulation Guidelines in Ghana

International Regulatory Affairs Focus: Australia : Human Insulin
15 August 2005; TGA - Therapeutic Goods Administration; Regulating Australia's medicines, medical devices, blood, tissues and chemicals. Two major suppliers of insulin in Australia have recently removed a number of products from the Australian market.Current human insulin and human insulin analogue situation

International Regulatory Affairs Focus: Canada: Biotechnology and the Health of Canadians
Biotech Watch - Canadian Biotechnology Advisory Committee Newsletter;
Volume 1, Issue 3; 10 August 2003. Few areas of biotechnology have a more direct impact on the daily lives of Canadians than health-related technologies....CBAC releases Biotechnology and the Health of Canadians

International Regulatory Affairs Focus: European Union: EMEA's new Draft Guidance: Pediatric Drugs

International Regulatory Affairs Focus: South Korea: World's First Dog Cloned
07 August, 2005; TaipeiTimes.com; AFP , SEOUL;Page 19. The world's first cloning of a dog heightens fear of human cloning Implications for Human Cloning

International Regulatory Affairs Focus: Regulation of Herbal Supplements
05 August 2005; MayoClinic.com; Herbal supplements: How they're labeled and regulated; By Mayo Clinic staff Labeling and Regulation of Herbal Supplements

International Regulatory Affairs Focus: CVMP Monthly Guidelines
04 August 2005; European Medicines Agency (EMEA); The Committee for Medicinal Products for Veterinary Use Has just published application procedures, guidelines and related documents in its Monthly Report

International Regulatory Affairs Focus: Japan, China, Singapore and Vietnam

International Regulatory Affairs Focus: Australian Regulatory Guidance
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) have been developed to provide information to help sponsors of complementary medicines to meet their obligations under therapeutic goods legislation, among others. Australian regulatory guidelines for complementary medicines (ARGCM)

International Regulatory Affairs Focus: International Health Regulations
Source: World Health Organization; 23 May, 2005; The World Health Organization's International Health Regulations (IHR)has been revised and adopted on May 23, 2005. For an understanding of the legal ramifications of this revision, click the link below for details. Revised IHR

International Regulatory Affairs Focus: Criminals Make Killing From Fake Drugs
01 August 2005; By Ben Hirschler; Source: Reuters Health/UCSF Children's Hospital; The World Health Organization (WHO) estimates that this illegal trade in Counterfeit Drugs is worth $30 billion a year

International Regulatory Affairs Focus: Canada's Smart Regulations

International Regulatory Affairs Focus: 31 Die of Pig-Borne Disease
Fri Jul 29, 1:21 PM ET; By AUDRA ANG, Associated Press Writer/Yahoo News 31 Die in China From Pig-Borne Disease

World's First DNA Vaccine Given Regulatory Approval
19 July 2005; Wyeth News and Announcements; Fort Dodge Animal Health Announces Approval of West Nile Virus DNA Vaccine for Horses West Nile Virus DNA Vaccine for Horses

Vision loss with Cialis, Levitra, Viagra

African sleeping sickness - drug resistance test discovered
Nesw From The University of Glasgow; Issued 06 July 2005 African Sleeping Sickness

FDA Approves Tygacil, First-In-Class Antibiotic

Plant-Made Pharmaceuticals

Africa-US Business Summit
Source: africacncl.org. The Summit strives to increase American investment throughout the African continent by increasing U.S. private sector awareness of the many commercial opportunities in Africa.. "IT IS PROBABLY THE MOST IMPORTANT EVENT FOR COMMERCIAL INTERESTS ON BOTH CONTINENTS"

International Regulatory Affairs Focus: "Diverted" Drugs Seized

West Nile Virus Treatment

International Regulatory Affairs Focus: Antidepressants in Children
Source: European Medicines Agency (EMA) Press Office European Medicines Agency (EMA) Finalises Review of Antidepressants in Children

Australia and Canada on Drug Regulations

International Regulatory Affairs Focus: Gene Technology Regulation in Australia

International Regulatory Affairs Focus: Better Medicines for Children

International Regulatory Affairs Focus: Pharmacogenomics Regulatory Guidance

Deadly Marburg Virus Is Spreading

FDA's Bioterrorism Act: two new guides

Pharmaceutical Rice Containing Human Genes?
Source: Delta Farm Press; Mar 31, 2005 10:17 AM
By David Bennett
Human Genes in Pharmaceutical Rice

China to Implement Additional GMP Regulations: An Update
Source: Pacific Bridge Medical - Asian Medical Newsletter; PACIFIC BRIDGE MEDICAL (PBM) is a leading Asia medical consulting firm dedicated to assisting medical companies in Asia. GMP Regulations in China

Japan: Medical Device Design Controls Under the New PAL

FDA / ICH GLP battery of genetic toxicity tests
Source: BioReliance (Invitrogen Bioservices): BioReliance is pleased to announce the launch of a new in vivo Comet assay – a sensitive technique which evaluates the genotoxic potential of a test compound to induce DNA damage in individual cells of different organ tissues. The in vivo Comet assay is a Tier II assay, meaning that it is used to provide more detailed information following a positive result in the standard FDA / ICH GLP battery of genetic toxicity tests.

Notice to Travelers about Avian Influenza A (H5N1)
Source: Whorld Health Organization/US Centers for Disease Control (CDC)Travel Notice

Anti-Cancer Compound Identified in Green Tea
Source: LONDON (Reuters). Tue Mar 15, 2005 01:05 AM ET By Patricia ReaneySpanish and British scientists have discovered how green tea helps to prevent certain types of cancer.

Application for New Medicines on The Rise
EMEA:14 March 2005 EMEA annual report shows rise in applications for new medicines in 2004, with further increases forecast for 2005 and 2006. Doc. Ref. EMEA/92603/2005New Medicines Applications

Drug Safety Labeling

NEW CLINIC FOR HIV-INFECTED CHILDREN in MALAWI

DNA Vaccines
Source: NewScientist.com news service
Shaoni Bhattacharya
17:35 03 February 2005
A new DNA vaccine may offer hope in the fight against one of the world's biggest killers - tuberculosis. Some two million people die of TB every year
DNA vaccine offers hope against tuberculosis

FDA may clear genetically enhanced salmon
Source: By MATT VOLZ
ASSOCIATED PRESS WRITER
Thursday, March 10, 2005 · Last updated 7:11 a.m. PT
Seattle Post-Intelligencer

A Massachusetts company expects to get the federal government's OK to sell genetically enhanced salmon within a year, a prospect that scares some Alaskan fishermen.Genetically Modified Fish for Food

Biotechnology News Updates
Source: European Association for Bioindustries
Genetically Modified Organisms

Traditional and Herbal Medicine's Growing Popularity
Source: World Health Organization (WHO)
The global market for herbal medicines currently stands at over US $ 60 billion annually and is growing steadily.
Worldwide Trend in Traditional and Herbal Medicine

A Tribute to Women
Source: The Commonwealth
International Women’s Day-- 8 March 2005

Released: 7 Mar 2005

International Women's Day focuses our attention on the key role played by women in development and democracy.

Women have proven to be the driving force of growth and development. Educating women, for example, leads to better health for their entire family, a healthier population and workforce and increased economic growth. As Samoa's Minister of Education, Fiame Naomi Mataafa, said recently, "countries that have good representation by women are those with a healthy economy, an effective democratic government and an educated population." Men benefit too when women take their rightful place in politics.
International Women's Day

Drug-Related Harm Reduction

Special Topic: Emerging Therapies and Technologies Guidance
Source: EMEA
Emerging Therapies and Technologies Guidance has been published, or existing text has been updated, please go to
Emerging Therapies

European Food Safety Authority Reacts to possible Goat BSE Infection
Source: FoodProductionDaily.com
31/01/2005 - The European Food Safety Authority (EFSA) has been asked by the Health and Consumer Protection Directorate General (DG SANCO) of the European Commission to provide scientific advice on the human health risks related to the consumption of goat milk and goat meat, following the suspected case of Bovine Spongiform Encephalopathy (BSE) infection in a goat.
Goat BSE Infection

Genetically Modified Crop Tests in Tanzania
Source: CheckBiotech.org
Monday, February 28, 2005
By Deodatus Balile

DAR ES SALAAM, Tanzania - will this year begin its first field trials of genetically modified (GM) crops. The first plants to be tested will be cotton modified to resist attack by insect pests, including a caterpillar known as red bollworm that feeds on cotton and causes bollworm disease.
Genetically Modified Crop Tests Get Green Light in Tanzania

Africa Should Have Drug Organization
Source: Newvision.co.ug

Author: Opiyo Oloya
Kampala

New Vision (Kampala)

OPINION
February 23, 2005
Posted to the web February 23, 2005

Date Posted on IRAUP.com Website: 26 February, 2005

AFRICAN countries should consider establishing a single continental drug approving body, the equivalent of the US Food and Drug Administration, Health Canada, and British Medicines and Healthcare Products Regulatory Agency (MHRA