2024-12-05-世界卫生组织-List_of_National_Regulatory_Authorities_NRAs_operating_at_maturity_level_3_ML3_and_maturity_level_4_ML4_3页_135kb

List of National Regulatory Authorities at Maturity Levels 3 and 4

This summary details the National Regulatory Authorities (NRAs) operating at WHO Global Benchmarking Tool (GBT)-assessed maturity levels, as of December 2024. Maturity Level 3 (ML3) indicates stable and well-functioning systems, while Maturity Level 4 (ML4) indicates advanced performance with continuous improvement. All entries are in alphabetical order by country.

• China: China National Medical Products Administration (NMPA) - ML3, Products: Vaccines (producing), Medicines (Announced 2022)
• Egypt: Egyptian Drug Authority (EDA) - ML3, Products: Medicines (Announced 2022)
• Ghana: Food and Drugs Authority (FDA) - ML3, Products: Vaccines (non-producing), Medicines (Announced 2020)
• India: National Drugs Controller General of India (CDSCO) - ML3, Products: Vaccines (producing), Medicines (Announced 2017 and 2024)
• Indonesia: National Agency of Drug and Food Control (BADAN POM) - ML3, Products: Vaccines (producing), Medicines (Announced 2019)
• Nigeria: National Agency for Food and Drug Administration and Control (NAFDAC) - ML3, Products: Vaccines (non-producing), Medicines (Announced 2022)
• Republic of Korea: Ministry of Food and Drug Safety (MFDS) - ML4, Products: Vaccines (producing), Medicines (Announced 2022)
• Rwanda: Food and Drug Authority (FDA) - ML3, Products: Vaccines (non-producing), Medicines (Announced 2024)
• Saudi Arabia: Saudi Food and Drug Authority (SFDA) - ML4, Products: Vaccines (producing), Medicines (Announced 2023)
• Sénégal: Agence sénégalaise de Réglementation Pharmaceutique - ML3, Products: Vaccines (producing), Vaccines (non-producing), Medicines (Announced 2024)
• Serbia: Medicines and Medical Devices Agency (ALIMS) - ML3, Products: Medicines (Announced 2019)
• Singapore: Health Sciences Authority (HSA) - ML4, Products: Vaccines (non-producing), Medicines (Announced 2022)
• South Africa: South African Health Products Regulatory Authority (SAHPRA) - ML3, Products: Vaccines (producing), Medicines (Announced 2022)
• Thailand: Food and Drug Administration (FDA) - ML3, Products: Medicines (Announced 2021)
• Türkiye: Turkish Medicines and Medical Devices Agency (TİTCK) - ML3, Products: Vaccines (producing), Medicines (Announced 2023)
• Tanzania (United Republic of): Medicines and Medical Devices Authority (TMDA) - ML3, Products: Vaccines (non-producing), Medicines (Announced 2018)
• Viet Nam: Multiple bodies (Drug Administration of Viet Nam, ASTT, NICVB, GDPM) - ML3, Products: Vaccines (producing), Medicines (Announced 2020)
• Zimbabwe: Medicines Control Authority of Zimbabwe (MCAZ) - ML3, Products: Vaccines (non-producing), Medicines (Announced 2024)

ML4 authorities include the Republic of Korea and Saudi Arabia. Both ML3 and ML4 systems regulate vaccines and medicines, though specifics vary by country. The list is subject to updates.