2024-05-19-世界卫生组织-List_of_WHO_Listed_Authorities_WLAs_21页_360kb

Summary of WHO-Listed Authorities (WLA)

• This list includes regulatory authorities recognized by the WHO for medicines and vaccines, featuring bodies from multiple countries and the European Medicines Regulatory Network (EMRN).
• Key functions encompassed across all authorities: registration and marketing authorization, vigilance, market surveillance and control, licensing establishments, regulatory inspection (including GMP, GSDP, GCP), laboratory testing, clinical trials oversight, and lot release.
• The majority of authorities (excluding a few exceptions) were first listed on May 13, 2024, with renewal dates set for June 2029.
• Notable exceptions include the Republic of Korea (first listed October 2028), Singapore (first listed May 2023 with renewal TBD), and Swissmedic (first listed November 2023 with renewal TBD), as well as European Commission and EMA entries with separate dates and renewals.
• Countries represented range from European nations like Austria and Belgium to global authorities like the US FDA, with a total of over 40 authorities listed.