Information About

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.