A stringent regulatory authority (SRA) is a national drug regulation authority which the World Health Organization (WHO) considers to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.
WHO definition A stringent regulatory authority is a regulatory authority which is:
a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before 23 October 2015); or
b) an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).
The concept of an SRA was developed by the WHO Secretariat and The Global Fund to Fight AIDS, Tuberculosis and Malaria to guide decisions regarding procurement of medicines for humanitarian assistance. The idea is that countries with non-SRA drug authorities can use accelerated process to facilitate approval (registration or marketing authorization) of medicines, including vaccines and biologics, which have already been approved by SRAs.
Replacement by the WHO-Listed Authority (WLA) framework In 2023, WHO formally replaced the SRA designation with the WHO-Listed Authority (WLA) framework, a new system for evaluating and publicly listing national and regional regulatory authorities that meet defined maturity and performance criteria.
Under the transition plan, regulatory authorities previously considered SRAs were granted “transitional WLA” (tWLA) status until March 2027 while undergoing formal evaluation.
The table below lists all currently designated WLAs , including the country, regulatory authority, and the date of first listing. CountryAuthorityDate of first listingAustraliaTherapeutic Goods Administration (TGA)16 December 2025AustriaAustrian Federal Office for Safety in Health Care (BASG)13 May 2024BelgiumFederal Agency for Medicines and Health Products (FAMHP)13 May 2024BulgariaBulgarian Drug Agency (BDA)13 May 2024CanadaHealth Canada21 July 2025CroatiaAgency for Medicinal Products and Medical Devices of Croatia (HALMED)13 May 2024CyprusPharmaceutical Services, Ministry of Health (PHS-MoH)13 May 2024CzechState Institute for Drug Control (SUKL)13 May 2024DenmarkDanish Medicines Agency (DKMA)13 May 2024EstoniaState Agency of Medicines (SAM)13 May 2024FinlandFinnish Medicines Agency (FIMEA)13 May 2024FranceThe French National Agency for Medicines and Health Products Safety (ANSM)13 May 2024GermanyFederal Institute for Drugs and Medical Devices (BfARM) / PaulEhrlich Institut - Federal Institute for Vaccines and Biomedicines (PEI)13 May 2024GreeceNational Organization for Medicines (EOF)13 May 2024HungaryNational Center for Public Health and Pharmacy (NNGYK)13 May 2024IcelandIcelandic Medicines Agency (IMA)13 May 2024IrelandHealth Products Regulatory Authority (HPRA)13 May 2024IndonesiaIndonesian Food and Drug Authority (BPOM)16 December 2025ItalyItalian Medicines Agency (AIFA)13 May 2024JapanMinistry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA)21 July 2025LatviaState Agency of Medicines of Latvia (ZVA)13 May 2024LiechtensteinOffice of Health/ Medicinal Products Control Agency (LLV)13 May 2024LithuaniaState Medicines Control Agency (VVKT)13 May 2024LuxembourgMinistry of Health (MoH)13 May 2024MaltaMalta Medicines Authority (MMA)13 May 2024NetherlandsMedicines Evaluation Board (CBG-MEB)13 May 2024NorwayNorwegian Medical Products Agency (NOMA)13 May 2024PolandOffice for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)13 May 2024PortugalNational Authority of Medicines and Health Products, IP (INFARMED)13 May 2024Republic of KoreaMinistry of Food and Drug Safety (MFDS)26 October 2023 and 21 July 2025 RomaniaNational Agency for Medicines and Medical Devices of Romania (NAMMDR)13 May 2024SingaporeHealth Sciences Authority (HSA)26 October 2023 and 13 May 2024SlovakiaState Institute for Drug Control (SUKL)13 May 2024SloveniaAgency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)13 May 2024SpainSpanish Agency of Medicines and Medical Devices (AEMPS)13 May 2024SwedenThe Swedish Medical Products Agency (SMPA)13 May 2024SwitzerlandSwissmedic26 October 2023United Kingdom of Great Britain and Northern IrelandMedicines & Healthcare products Regulatory Agency (MHRA)21 July 2025United States of America Food and Drug Administration (USFDA)13 May 2024
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