2023-10-29-世界卫生组织-List_of_WHO_Listed_Authorities_WLAs_2页_131kb

List of WHO-Listed Authorities (WLA) as of October 2023

• Republic of Korea Food and Drug Safety (MFDS):

  • Contact Point: intlpharm@korea.kr
  • Key Functions:
    • Registration and marketing authorization for medicines.
    • Licensing establishments.
    • Regulatory inspections (GMP/GSDP, GCP).
    • Clinical trials oversight.
    • Vigilance, market surveillance and control.
    • Laboratory testing.
    • Includes oversight of generics, new chemical entities, biologics.
  • Renewal: TBC, initially for 5 years following October 2023 listing date. Also lists a relevant website link.

• Singapore Health Sciences Authority (HSA):

  • Contact Point: hsa_intl_office@hsa.gov.sg
  • Key Functions: Similar to MFDS, includes registration/market authorization, inspections, GMP/GSDP/GCP, biotherapeutics, clinical trials, vigilance, surveillance, licensing, laboratory testing and lot release.
  • Renewal: TBC, initially for 5 years following October 2023 listing date. Also lists a relevant website link.

• Swissmedic:

  • Contact Point: Networking@swissmedic.ch
  • Key Functions: Registration/market authorization, vigilance, surveillance, inspections, GMP/GSDP/GCP, clinical trials oversight, laboratory testing, batch release. Includes oversight of multisource generics, new chemical entities, and biotherapeutics/vaccines.
  • Renewal: TBC, initially for 5 years following October 2023 listing date. Also lists relevant website links for both general and vaccines regulatory functions.