Major regulatory agencies across the world

Major regulatory agencies across the world

Here is a list of major regulatory agencies across the world that are responsible for drug approvals and pharmaceutical regulation:

🌍 Global and Regional Regulatory Agencies

Agency Region Description
WHO – World Health Organization (Prequalification Programme) Global Provides guidance and prequalification for medicines used in global public health programs. Not an approval agency per se, but sets standards and lists prequalified products.

🌎 North America Regulatory Agencies

Agency Country Description
FDA – Food and Drug Administration United States Regulates drugs, biologics, vaccines, and medical devices.
Health Canada (HPFB – Health Products and Food Branch) Canada Regulates drug approval and monitoring of health products.
COFEPRIS – Federal Commission for the Protection Against Sanitary Risk Mexico Oversees pharmaceuticals, health products, and food safety.

🌍 Europe

Agency Country / Region Description
EMA – European Medicines Agency European Union Centralized procedure for drug approvals across EU member states.
MHRA – Medicines and Healthcare products Regulatory Agency United Kingdom Regulates drugs and medical devices post-Brexit.
ANSM – National Agency for the Safety of Medicines and Health Products France Regulates health products in France.
BfArM – Federal Institute for Drugs and Medical Devices Germany Responsible for drug regulation in Germany.
AIFA – Italian Medicines Agency Italy Oversees pharmaceutical products in Italy.

🌏 Asia

Agency Country Description
CDSCO – Central Drugs Standard Control Organization India National regulatory body for drugs and medical devices.
PMDA – Pharmaceuticals and Medical Devices Agency Japan Works with MHLW to evaluate drugs, devices, and biologics.
NMPA – National Medical Products Administration (formerly CFDA) China Regulates drug, medical device, and cosmetic approvals.
MFDS – Ministry of Food and Drug Safety South Korea Ensures safety and quality of drugs and food.
HSA – Health Sciences Authority Singapore Regulatory authority for health products including pharmaceuticals.

🌍 Africa

Agency Country Description
NDA – National Drug Authority Uganda Regulates drug use and production in Uganda.
SAHPRA – South African Health Products Regulatory Authority South Africa Oversees medicines, medical devices, and clinical trials.
Pharmacy and Poisons Board Kenya Responsible for regulation of pharmacy practice and drugs.
AMA – African Medicines Agency (In progress) African Union A new pan-African agency aiming to harmonize regulations across African countries.

🌎 South America

Agency Country Description
ANVISA – National Health Surveillance Agency Brazil Oversees drug approvals, health surveillance, and food safety.
INVIMA – National Institute for Food and Drug Surveillance Colombia Regulates pharmaceutical products and health supplies.
ISP – Public Health Institute of Chile Chile Regulates drugs, food, and cosmetics.
ANMAT – National Administration of Drugs, Foods and Medical Devices Argentina Supervises medicines and medical devices.

🌏 Oceania Regulatory agencies

Agency Country Description
TGA – Therapeutic Goods Administration Australia Regulates therapeutic goods including medicines and devices.
Medsafe New Zealand Responsible for regulating medicines and medical devices.

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