“Stringent Regulatory Authority or SRA” is a term that was developed by the WHO Secretariat and the Global Fund to Fight AIDS, Tuberculosis and Malaria. The purpose was to provide some guidance to organisations who procure medicines and to help them with their qualification, risk assessment and approval of their suppliers. “SRA” is now widely recognised and the term is used by the international regulatory and procurement community. WHO prequalification procedures and several other WHO guidance documents relating to the quality of medicines provide mechanisms to rely on SRAs.
ICH has undergone structural changes and has expanded its reach to include global organisations and associations. In view of these developments, the WHO Secretariat proposed an interim definition of an SRA. The interim definition of an SRA includes the same elements as the current definition, each qualified by the wording “as before 23 October 2015”, as follows:
“A regulatory authority which is:
- 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
- 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).”