Перечень регуляторных органов, включённых в список ВОЗ (WHO Listed Authorities) и/или имеющих уровень зрелости ML-4.

1. Австрия – Austrian Federal Office for Safety in Health Care (BASG)
2. Бельгия – Federal Agency for Medicines and Health Products (FAMHP)
3. Болгария – Bulgarian Drug Agency (BDA)
4. Канада – Health Canada
5. Хорватия – Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
6. Кипр – Pharmaceutical Services, Ministry of Health (PHS-MoH)
7. Чехия – State Institute for Drug Control (SUKL)
8. Дания – Danish Medicines Agency (DKMA)
9. Эстония – State Agency of Medicines (SAM)
10. Финляндия – Finnish Medicines Agency (FIMEA)
11. Франция – French National Agency for Medicines and Health Products Safety (ANSM)
12. Германия – Federal Institute for Drugs and Medical Devices (BfArM)
13. Греция – National Organization for Medicines (EOF)
14. Венгрия – National Center for Public Health and Pharmacy (NNGYK)
15. Исландия – Icelandic Medicines Agency (IMA)
16. Ирландия – Health Products Regulatory Authority (HPRA)
17. Италия – Italian Medicines Agency (AIFA)
18. Япония – Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)
19. Латвия – State Agency of Medicines of Latvia (ZVA)
20. Лихтенштейн – Office of Health / Medicinal Products Control Agency (LLV)
21. Литва – State Medicines Control Agency (VVKT)
22. Люксембург – Ministry of Health
23. Мальта – Malta Medicines Authority (MMA)
24. Нидерланды – Medicines Evaluation Board (CBG-MEB)
25. Норвегия – Norwegian Medical Products Agency (NOMA)
26. Польша – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)
27. Португалия – National Authority of Medicines and Health Products, IP (INFARMED)
28. Республика Корея (Южная Корея) – Ministry of Food and Drug Safety (MFDS)
29. Румыния – National Agency for Medicines and Medical Devices of Romania (NAMMDR)
30. Сингапур – Health Sciences Authority (HSA)
31. Словакия – State Institute for Drug Control (SUKL)
32. Словения – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)
33. Испания – Spanish Agency of Medicines and Medical Devices (AEMPS)
34. Швеция – Swedish Medical Products Agency (SMPA)
35. Швейцария – Swissmedic
36. Великобритания – Medicines and Healthcare products Regulatory Agency (MHRA)
37. Соединённые Штаты Америки (США) – US Food and Drug Administration (US FDA)
38. Европейская сеть регуляторных органов по лекарственным средствам (European Medicines Regulatory Network) – European Commission (DG SANTE), European Medicines Agency (EMA), National Regulatory Authorities

Страны и регуляторные органы (уровень зрелости 4, ML4)

1. Республика Корея – Ministry of Food and Drug Safety (MFDS)
2. Саудовская Аравия – Saudi Food and Drug Authority (SFDA)
3. Сингапур – Health Sciences Authority (HSA)