Regulatory Agencies
USA
The Department of Health and Human Services (DHHS)
The Office of Human Research Protections (OHRP)
OHRP Links to Reference Documents
The Food and Drug Administration (FDA)
FDA Center for Biologics Evaluation and Research (CBER)
CBER Resources for Cellular and Gene Therapy
FDA Center for Drug Evaluation and Research (CDER)
FDA Center for Devices and Radiological Health (CDRH)
The National Institutes of Health (NIH)
NIH Office of Biotechnology Activities (OBA)
NIH Office of Human Subjects Research (OHSR)
Europe
European Medicines Agency (EMEA)
UK
Medicines and Healthcare products Regulatory Agency (MHRA)
Scientific Advisory Committee on Genetically Modified Organisms (ACGMO)
Gene Therapy Advisory Committee (GTAC)
Asia
Chinese Ministry of Public Health (CMPH)
State Food and Drug Administration of China (SFDA)
Australia
Department of Health and Ageing (DHA)
Office of the Gene Technology Regulator (OGTR)
