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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