Reference National Regulatory Authorities for Medicines, Vaccines and New Molecule Entities

Reference National Regulatory Authorities Identified for Market Authorization of Medicines

1. Australia-TGA

2. Austria-AGES

3. Belgium-FAMPH

4. Bulgaria-BDA

5 Canada-Health Canada

6. Croatia-HALMED

7. Cyprus-MoH-PHS

8. Czech Republic-SUKL

9. Denmark DKMA

10. Estonia-SAM

11. Finland-FIMEA

12. France-ANSM

13. Germany-BfARM & PEI

14. Greece-EOF

15. Hungary-OGYEI

16. Iceland-IMA

17. Ireland-HPRA

18. Italy-AIFA

19. Japan-PMDA

20. Latvia-ZVA

21. Liechtenstein - Office of Health

22. Lithuania - VVKT

23. Luxembourg-MoH

24. Malta-Medicines Authority

25. Netherlands - MEB

26. Norway - NOMA

27. Poland-URPL

28. Portugal-INFARMED

29. Romania-ANMDMR

30. Slovakia-SUKLO

31. Slovenia - JAZMP

32. Spain-AEMPS

33. Sweden-SMPA

34. United Kingdom of Great Britain and Northern Ireland-MHRA

35. United States of America - USFDA

36. European Medicines Regulatory Network

Reference National Regulatory Authorities Identified for Market Authorization of Vaccines and New Molecule Entities

1. Australia-TGA

2. Belgium - FAMPH

3. Canada-Health Canada

4. France-ANSM

5. Germany - BfArM & PEI

6. Italy-AIFA

7. Netherlands - MEB

8. United Kingdom of Great Britain and Northern Ireland - MHRA

9. United States of America - USFDA

( Date: 29 May 2024)