Resource Links

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Resource Links

The following links will connect you to the appropriate government websites for country-specific information on regulations and policies governing clinical research worldwide.

International

World Health Organization

International Conference on Harmonisation

Global Harmonization Task Force

Asia Pacific

Australia
Department of Health and Ageing

Therapeutic Goods Administration (TGA)

China
State Drug Administration of Traditional Chinese Medicines of the People's Republic of China

National Institute for the Control of Pharmaceutical and Biological Products

State Food and Drug Administration

India
Ministry of Health and Family Welfare

Central Drug Standards Control Organisation

Japan
Pharmaceuticals and Medical Devices Evaluation Center

Ministry of Health, Labour and Welfare

Singapore
Health Sciences Authority (HSA)

Europe

European Medicines Agency (EMEA)

European Commission: Enterprise and Industry DG: Pharmaceuticals Unit

European Commission: Health and Consumer Protection DG

Heads of Medicines Agencies (HMA) for European Union

National Regulatory Bodies in the European Union

North America

Canada
The Health Products and Food Branch (HPFB)

National Association of Pharmacy Regulatory Authorities (NAPRA)

United States
U.S. Food and Drug Administration (FDA)

Office for Human Research Protections (OHRP)

National Institutes of Health (NIH)

ClinicalTrials.gov

FDA's Critical Path Initiative


For more National Regulatory Agencies by geographic location, click here.

Click here for information on the partnerships and affiliations ACRO maintains to foster cross-industry cooperation and to enhance the clinical research enterprise.

 

The Case for Globalization