List of Regulatory Authorities

 

List of Drug Regulatory Authorities of Different Countries

Asia

1. India - The Central Drugs Standard Control Organisation(CDSCO)

2. Pakistan - Drug Regulatory Authority Of Pakistan

3. China - The National Medical Products Administration (NMPA)

4. Malaysia - National Pharmaceutical Regulatory Agency (NPRA)

5. Saudi Arabia - The Saudi Food & Drug Authority (SFDA) 

6. UAE - The UAE Ministry of Health (MOH)

7. Philippines - The Food and Drug Administration (FDA) of the Philippines

8. Japan – Pharmaceuticals and Medical Devices Agency (PMDA) & Japan Pharmacists Education Center (JPEC)

9. Bangladesh - Directorate General of Drug Administration (DGDA)

10. Israel – Ministry of Health

11. Nepal - Department of Drug Administration

12. Bahrain - National Health Regulatory Authority Bahrain

13. South Korea - The Ministry of Food and Drug Safety (MFDS)

14. Taiwan - Taiwan's Food and Drug Administration (TFDA)

15. Egypt - Egyptian Drug Authority (EDA)

16. Kuwait - Kuwait Food and Drug Authority (KuFDA)

17. Iran - Iranian food and drug organization (FDO)

18. Indonesia - National Agency of Drug and Food Control

19. Thailand - Thailand Food And Drug Administration (Thai FDA)

20. Jordan Food and Drug Administration

21. Hong Kong- Department of Health | Central Drugs Standard Control Organization

22. Sri Lanka- Cosmetics, Devices & Drugs Regulatory Authority | Ministry of Health

Australia & USA

1. Australia – Therapeutic Goods Administration (TGA)

2. Canada – Health Canada

3. New Zealand – Medicines and Medical Device Safety Authority (Medsafe)

4. USA – U.S. Food and Drug Administration (FDA)

Read also: Pharmaceutical Regulatory Affairs Interview Questions and Answers

Latin America

1. Argentina: National Administration of Drugs, Foods and Medical Devices (ANMAT)

2. Brazil: Brazilian Health Surveillance Agency (ANVISA)

3. Chile: Public Health Institute of Chile (ISPCH)

4. Colombia: Ministry of Health and Social Protection

5. Costa Rica: Ministry of Health

6. Ecuador: National Agency for Regulation, Control and Sanitary Surveillance (ARCSA)

7. Mexico: Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

8. Panama: Ministry of Health

9. Peru General Directorate of Medicines, Supplies and Drugs (DIGEMID)

10. Venezuela National Institute of Hygiene “Rafael Rangel” | Autonomous Health Service Comptroller (SACS)

Read also: Regulatory Inspection Management in Pharmaceutical Industry

Europe

1. European Medicines Agency - EMA

2. Heads of Medicines Agencies - HMA

3. Austria- Federal Ministry of Health

4. Belgium - Federal Agency for Medicines & Health Products

5. Bulgaria - Bulgarian Drug Agency

6. Croatia - Agency for Medicinal Products and Medical Devices | Ministry of Health

7. Cyprus - Ministry of Health

8. Czech Republic - State Institute for Drug Control

9. Denmark - Danish Medicines Agency

10. Estonia - State Agency of Medicines Finland-Finnish Medicines Agency | National Supervisory Authority for Welfare and Health

11. France - National Agency for the Safety of Medicines and Health Products (ANSM)

12. Germany - Federal Institute for Drugs and Medical Devices (BfArM)

13. Greece - National Organization for Medicines (EOM)

14. Hungary - National Institute of Pharmacy and Nutrition

15. Ireland - Health Products Regulatory Authority

16. Italy - Italian Medicines Agency

17. Latvia - State Agency of Medicines | Ministry of Health

18. Lithuania - State Medicines Control Agency (SMCA)

19. Malta - Medicines Authority

20. Netherlands - Medicines Evaluation Board | Health Care Inspectorate (IGZ)

21. Poland - Poland Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) | Ministry of Health

22. Portugal - National Authority of Medicines and Health

23. Romania - The National Agency for Medicines and Medical Devices (NAMMD)

24. Slovak Republic - State Institute for Drug Control

25. Slovenia - Agency for Medicinal Products and Medical

26. Spain-Ministry of Health, Social Services and Equality

27. Sweden - Medical Products Agency

28. Switzerland – Swiss Agency for Therapeutic Products (Swissmedic)

29. United Kingdom - Medicines and Healthcare Products Regulatory Agency

30. Iceland – Icelandic Medicines Agency (IMA)

31. Finland – National Agency for Medicines (FIMEA)

32. Colombia – Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)

33. Russia - The Ministry of Health (Minzdrav)

34. Albania - The National Agency of Drugs and Medical Equipment

35. Georgia - Georgia Drugs and Narcotics Agency

36. Turkey - Turkish Medicines and Medical Devices Agency

37. Belarus- Center for Examinations and Tests in Health

38. Bosnia & Herzegovina-  Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina | Ministry of Health of the Federation of Bosnia and Herzegovina

39. Kosovo- Kosovo Medicines Agency | Ministry of Health

40. Macedonia-  Agency for Medicinal Products and Medical Devices | Ministry of Health

41. Montenegro-  Agency for Medicines and Medical Devices | Ministry of Health

42. Norway- Norwegian Medicines Agency

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Africa

1. Algeria - Ministry of Health, Population and Hospital Reform

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

3. Zimbabwe - Medicines Control Authority of Zimbabwe

4. South Africa - South African Health Products Regulatory Authority (SAHPRA)

5. Kenya - The Pharmacy and Poisons Board

6. Sudan - Drugs & Food Control Authority

7. Morocco - Ministry of Health

Related: FDA Pre-Approval Inspection