2023-10-26-世界卫生组织-List_of_National_Regulatory_Authorities_NRAs_operating_at_maturity_level_3_ML3_and_maturity_level_4_ML4_2页_130kb

Summary of National Regulatory Authorities

Origin of Data: List of NRAs benchmarked against WHO GBT, as of October 2023, in alphabetical order.

Maturity Level Definitions:

• ML3: "Stable, well-functioning, and integrated regulatory systems."
• ML4: "Regulatory systems operating at an advanced level of performance and continuous improvement."

Maturity Level 3 (ML3) NRAs

• China: National Medical Products Administration (NMPA), products: vaccines (producing).
• Egypt: Egyptian Drug Authority (EDA), products: medicines.
• Ghana: Food and Drugs Authority (FDA), products: vaccines (non-producing).
• India: Central Drugs Standard Control Organisation (CDSCO), products: vaccines (producing).
• Indonesia: National Agency of Drug and Food Control (BADAN POM), products: medicines.
• Nigeria: National Agency for Food and Drug Administration and Control (NAFADAC), products: medicines and vaccines (non-producing).
• Republic of Korea: Not listed under ML3; it is ML4.
• Saudi Arabia: Not listed under ML3; it is ML4.
• Serbia: Medicines and Medical Devices Agency (ALIMS), products: medicines.
• South Africa: South African Health Products Regulatory Authority (SAHPRA), products: vaccines (producing).
• South Korea: Not ML3; listed under ML4.
• Singapore: Not ML3; listed under ML4.
• Taiwan: Not explicitly listed in the provided data.
• Tanzania: Medicines and Medical Devices Authority (TMDA), products: medicines and vaccines (non-producing).
• Thailand: Food and Drug Administration (FDA), products: medicines.
• Turkey: Turkish Medicines and Medical Devices Agency (TİTCK), products: vaccines (producing).
• Turkiye: Not explicitly listed, but similar to Turkey.
• United Republic of Tanzania: Same as above.
• Viet Nam: Multiple entities: Drug Administration of Viet Nam (DAV), Administration of Science, Technology and Training (ASTT), National Institute for the Control of Vaccines and Biologicals (NICVB), General Department of Preventive Medicine (GDPM), all products: vaccines (producing).

Maturity Level 4 (ML4) NRAs

• Republic of Korea: Ministry of Food and Drug Safety (MFDS), products: medicines and vaccines (producing).
• Saudi Arabia: Saudi Food and Drug Authority (SFDA), products: vaccines (producing).
• Singapore: Health Sciences Authority (HSA), products: vaccines (non-producing).

Note: The list is subject to updates as new information becomes available.