“List of regulatory authorities included in the World Health Organization (WHO) Listed Authorities and/or those with Maturity Level 4 (ML-4) status.”

• Austria – Austrian Federal Office for Safety in Health Care (BASG)

• Belgium – Federal Agency for Medicines and Health Products (FAMHP)

• Bulgaria – Bulgarian Drug Agency (BDA)

• Canada – Health Canada

• Croatia – Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

• Cyprus – Pharmaceutical Services, Ministry of Health (PHS-MoH)

• Czech Republic – State Institute for Drug Control (SÚKL)

• Denmark – Danish Medicines Agency (DKMA)

• Estonia – State Agency of Medicines (SAM)

• Finland – Finnish Medicines Agency (FIMEA)

• France – French National Agency for Medicines and Health Products Safety (ANSM)

• Germany – Federal Institute for Drugs and Medical Devices (BfArM)

• Greece – National Organization for Medicines (EOF)

• Hungary – National Center for Public Health and Pharmacy (NNGYK)

• Iceland – Icelandic Medicines Agency (IMA)

• Ireland – Health Products Regulatory Authority (HPRA)

• Italy – Italian Medicines Agency (AIFA)

• Japan – Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)

• Latvia – State Agency of Medicines of Latvia (ZVA)

• Liechtenstein – Office of Health / Medicinal Products Control Agency (LLV)

• Lithuania – State Medicines Control Agency (VVKT)

• Luxembourg – Ministry of Health

• Malta – Malta Medicines Authority (MMA)

• Netherlands – Medicines Evaluation Board (CBG-MEB)

• Norway – Norwegian Medical Products Agency (NOMA)

• Poland – Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)

• Portugal – National Authority of Medicines and Health Products, IP (INFARMED)

• Republic of Korea (South Korea) – Ministry of Food and Drug Safety (MFDS)

• Romania – National Agency for Medicines and Medical Devices of Romania (NAMMDR)

• Singapore – Health Sciences Authority (HSA)

• Slovakia – State Institute for Drug Control (SÚKL)

• Slovenia – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

• Spain – Spanish Agency of Medicines and Medical Devices (AEMPS)

• Sweden – Swedish Medical Products Agency (SMPA)

• Switzerland – Swissmedic

• United Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA)

• United States of America – US Food and Drug Administration (US FDA)

• European Medicines Regulatory Network – European Commission (DG SANTE), European Medicines Agency (EMA), National Regulatory Authorities

Maturity Level 4 (ML-4) status.

• Republic of Korea – Ministry of Food and Drug Safety (MFDS)

• Saudi Arabia – Saudi Food and Drug Authority (SFDA)

• Singapore – Health Sciences Authority (HSA)