list of stringent regulatory authorities list of stringent regulatory authorities 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. 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). 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. 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. as of 2022, the national regulatory authorities of 36 countries are considered sras: 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