List of stringent regulatory authorities
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.[1]
WHO definition
[edit]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).[1]
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.[2] 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.[1]
Replacement by the WHO-Listed Authority (WLA) framework
[edit]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.[3]
Under the transition plan, regulatory authorities previously considered SRAs were granted “transitional WLA” (tWLA) status until March 2027 while undergoing formal evaluation.[4]
The table below lists all currently designated WLAs as of July 2025, including the country, regulatory authority, and the date of first listing.[5]
| Country | Authority | Date of first listing |
|---|---|---|
| Austria | Austrian Federal Office for Safety in Health Care (BASG) | 13 May 2024 |
| Belgium | Federal Agency for Medicines and Health Products (FAMHP) | 13 May 2024 |
| Bulgaria | Bulgarian Drug Agency (BDA) | 13 May 2024 |
| Canada | Health Canada | 21 July 2025 |
| Croatia | Agency for Medicinal Products and Medical Devices of Croatia (HALMED) | 13 May 2024 |
| Cyprus | Pharmaceutical Services, Ministry of Health (PHS-MoH) | 13 May 2024 |
| Czech | State Institute for Drug Control (SUKL) | 13 May 2024 |
| Denmark | Danish Medicines Agency (DKMA) | 13 May 2024 |
| Estonia | State Agency of Medicines (SAM) | 13 May 2024 |
| Finland | Finnish Medicines Agency (FIMEA) | 13 May 2024 |
| France | The French National Agency for Medicines and Health Products Safety (ANSM) | 13 May 2024 |
| Germany | Federal Institute for Drugs and Medical Devices (BfARM) / PaulEhrlich Institut - Federal Institute for Vaccines and Biomedicines (PEI) | 13 May 2024 |
| Greece | National Organization for Medicines (EOF) | 13 May 2024 |
| Hungary | National Center for Public Health and Pharmacy (NNGYK) | 13 May 2024 |
| Iceland | Icelandic Medicines Agency (IMA) | 13 May 2024 |
| Ireland | Health Products Regulatory Authority (HPRA) | 13 May 2024 |
| Italy | Italian Medicines Agency (AIFA) | 13 May 2024 |
| Japan | Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) | 21 July 2025 |
| Latvia | State Agency of Medicines of Latvia (ZVA) | 13 May 2024 |
| Liechtenstein | Office of Health/ Medicinal Products Control Agency (LLV) | 13 May 2024 |
| Lithuania | State Medicines Control Agency (VVKT) | 13 May 2024 |
| Luxembourg | Ministry of Health (MoH) | 13 May 2024 |
| Malta | Malta Medicines Authority (MMA) | 13 May 2024 |
| Netherlands | Medicines Evaluation Board (CBG-MEB) | 13 May 2024 |
| Norway | Norwegian Medical Products Agency (NOMA) | 13 May 2024 |
| Poland | Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) | 13 May 2024 |
| Portugal | National Authority of Medicines and Health Products, IP (INFARMED) | 13 May 2024 |
| Republic of Korea | Ministry of Food and Drug Safety (MFDS) | 26 October 2023 and 21 July 2025 |
| Romania | National Agency for Medicines and Medical Devices of Romania (NAMMDR) | 13 May 2024 |
| Singapore | Health Sciences Authority (HSA) | 26 October 2023 and 13 May 2024 |
| Slovakia | State Institute for Drug Control (SUKL) | 13 May 2024 |
| Slovenia | Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) | 13 May 2024 |
| Spain | Spanish Agency of Medicines and Medical Devices (AEMPS) | 13 May 2024 |
| Sweden | The Swedish Medical Products Agency (SMPA) | 13 May 2024 |
| Switzerland | Swissmedic | 26 October 2023 |
| United Kingdom of Great Britain and Northern Ireland | Medicines & Healthcare products Regulatory Agency (MHRA) | 21 July 2025 |
| United States of America | Food and Drug Administration (USFDA) | 13 May 2024 |
References
[edit]- ^ a b c World Health Organization & WHO Expert Committee on Specifications for Pharmaceutical Preparations (2018). Fifty-second report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (PDF). Geneva, Switzerland: World Health Organization. p. 355–6. ISBN 978-92-4-121019-5. OCLC 1039407367.
- ^ No authors listed. "WHO | List of Stringent Regulatory Authorities (SRAs)". World Health Organization. Retrieved 2022-08-30.
{{cite web}}: CS1 maint: url-status (link) - ^ World Health Organization. "WHO-Listed Authorities". World Health Organization. Retrieved 2025-11-23.
{{cite web}}: CS1 maint: url-status (link) - ^ World Health Organization. "WHO Listed Authorities: Questions and Answers". World Health Organization. Retrieved 2025-11-23.
{{cite web}}: CS1 maint: url-status (link) - ^ World Health Organization. "List of WHO‑Listed Authorities (WLA)" (PDF). World Health Organization. Retrieved 2025-11-23.
{{cite web}}: CS1 maint: url-status (link)