Human Medicine: Regulatory Guidances/Regulations
reg guidances, regulations, inspections, position papers, current thinking
Acronyms used in the EU :
EMEA Inspections : Activities of the EMEA Inspector
EMEA Medicinal Products Regulations : Product safety, Application Procedures, Guidances, Regulations, Position Papers, Pharmacovigilance
EMEA Presubmission Guidelines :
FDA Export Certificates : Guidance Documents for Industry
Gene Technology Regulations in Australia : What you need to know about the Regulation of Gene Technology in Australia.
Med Dev publications :
Pharmacos : European Pharmacos
Pharmacovigilance in the European Commission :
Regulation of Medical Devices in Australia : Various Rules,Regulations and Guidances relevant to Medical Device Regulations in Australia.