List of stringent regulatory authorities

Source: Wikipedia, the free encyclopedia.

A stringent regulatory authority (SRA) is a national drug regulation authority which is considered by the World Health Organization (WHO) to apply stringent standards for quality, safety, and efficacy in its process of regulatory review of drugs and vaccines for marketing authorization.[1]

The official WHO definition 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]

As of 2020, the national regulatory authorities of 35 countries are considered SRAs:[2]

Country Authority Criterion for consideration as SRA
Australia Therapeutic Goods Administration Mutual recognition agreement with ICH members
Austria Austrian Agency for Health and Food Safety (AGES) EC member
Belgium Federal Agency for Medicines and Health Products (FAMHP) EC member
Bulgaria Bulgarian Drug Agency EC member
Canada Health Canada ICH observer
Cyprus Ministry of Health — Pharmaceutical Services EC member
Czech Republic State Institute for Drug Control (SUKL) EC member
Denmark Danish Medicines Agency EC member
Estonia State Agency of Medicines (Ravimiamet) EC member
Finland Finnish Medicines Agency (Fimea) EC member
France National Agency for the Safety of Medicine and Health Products (ANSM) EC member
Germany Federal Institute for Drugs and Medical Devices EC member
Greece National Organization for Medicines EC member
Hungary National Institute of Pharmacy and Nutrition (OGYEI) EC member
Iceland Icelandic Medicines Agency EFTA member/mutual recognition agreement
Ireland Health Products Regulatory Authority EC member
Italy Italian Medicines Agency (AIFA) EC member
Japan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency ICH member
Latvia State Agency of Medicines EC member
Liechtenstein Office of Health / Department of Pharmaceuticals EFTA member/mutual recognition agreement
Lithuania State Medicines Control Agency (VVKT) EC member
Luxembourg Ministry of Health EC member
Malta Medicines Authority EC member
Netherlands Health and Youth Care Inspectorate (IGZ) EC member
Norway Norwegian Medicines Agency EFTA member/mutual recognition agreement
Poland Chief Pharmaceutical Inspectorate EC member
Portugal National Authority of Medicines and Health Products (Infarmed) EC member
Romania National Agency for Medicines and Medical Devices EC member
Slovakia State Institute for Drug Control (SIDC) EC member
Slovenia Agency for Medicinal Products and Medical Devices (JAZMP) EC member
Spain Spanish Agency of Medicines and Medical Devices (AEMPS) EC member
Sweden Medical Products Agency EC member
Switzerland Swiss Agency for Therapeutic Goods (Swissmedic) ICH observer/EFTA member
United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) EC member
United States of America Food and Drug Administration ICH member

References

  1. ^ 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.
  2. ^ a b No authors listed (2020-06-22). "WHO | List of Stringent Regulatory Authorities (SRAs)". World Health Organization. Retrieved 2020-12-15.