Regulatory Agencies

Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue guidelines for drug development,licensing, registration, manufacturing, marketing and labeling of pharmaceutical products.

There are some name of the Drug Regulatory Authorities of different countries:

USA - Food and Drug Administration (FDA)

UK - Medicines and Healthcare Products Regulatory Agency (MHRA)

Australia - Therapeutic Goods Administration (TGA)

Bangladesh - Directorate General of Drug Administration (DGDA)

India - Central Drug Standard Control Organization (CDSCO)

Canada - Health Canada

Egypt - Ministry of Health and Population

Europe - European Medicines Agency (EMEA)

Finland - Finnish Medicines Agency

Denmark - Danish Medicines Agency

Costa Rica - Ministry of Health

New Zealand - Medsafe - Medicines and Medical Devices Safety Authority

Sweden - Medical Products Agency (MPA)

Netherlands - Medicines Evaluation Board

Ireland - Irish Medicines Board

Italy - Italian Pharmaceutical Agency

Spain - Medicines and Health Products Agency (AEMPS)

France - Agence Française de Sécurité Sanitaire des Aliments

Nigeria - National Agency for Food and Drug Administration and Control (NAFDAC)

Ukraine - Ministry of Health

Singapore - Centre for Pharmaceutical Administration Health Sciences Authority

Hong Kong - Pharmacy and Poisons Board of Hong Kong

Paraguay - Ministry of Health

Saudi Arabia - Ministry of Health

Thailand - Ministry of Public Health

China - State Food and Drug Administration

Germany - Federal Institute for Drugs and Medical Devices

Malaysia - National Pharmaceutical Control Bureau,Ministry of Health

Pakistan - Drug Regulatory Authority of Pakistan

South Africa - Medicines Control Council

Russia - Association of International Pharmaceutical Manufacturers

Romania - National Medicines Agency (ANM)

Sri Lanka - SPC,Ministry of Health

Switzerland - Swissmedic , Swiss Agency for Therapeutic Products

Uganda - Uganda National Council for Science and Technology (UNCST)

Brazil - Agencia Nacional de Vigiloncia Sanitaria (ANVISA )

Mexico - Ministry of Health

Norway - Norwegian Medicines Agency

Japan - Ministry of Health, Labour & Welfare(MHLW)

International Drug and Health Regulatory Authorities:

International Conference on Harmonisation (ICH)

World Health Organization (WHO)

World Trade Organization (WTO)


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