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]
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]
As of 2022, the national regulatory authorities of 36 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 | |
| Croatia | Agency for Medicinal Products and Medical Devices of Croatia (HALMED) | EC member | |
| 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 Products (Swissmedic) | ICH observer/EFTA member | |
| United Kingdom | Medicines and Healthcare products Regulatory Agency (MHRA) | EC member (as before 23 October 2015) | |
| United States of America | Food and Drug Administration | ICH member |