Top Qs
Timeline
Chat
Perspective
List of stringent regulatory authorities
Agencies that strongly protect health and safety in medicine From Wikipedia, the free encyclopedia
Remove ads
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
Summarize
Perspective
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]
Remove ads
Replacement by the WHO-Listed Authority (WLA) framework
Summarize
Perspective
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]
Remove ads
References
Wikiwand - on
Seamless Wikipedia browsing. On steroids.
Remove ads