{"entity":{"id":"regulatory-agencies","kind":"term","name":"Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)","aka":["CHMP","Committee for Medicinal Products for Human Use","MHRA","PMDA","NMPA","TGA","Health Canada","Swissmedic","ANVISA","regulator","regulators","regulatory agency","regulatory agencies","regulatory approval","marketing authorisation","marketing authorization","European Commission approval","EU approval","approved in the EU","approved in Japan","approved in China","approved in the UK","multiregional","multi-regional trial","China-only data","reliance pathway","Access Consortium","marketing authorisations","reliance pathways"],"tldr":"Every country or bloc has its own drug regulator: the EMA (with its CHMP committee) for the EU, the MHRA for the UK, the PMDA for Japan, the NMPA for China, the TGA for Australia. The same drug can be approved in one place years before another, or on different evidence.","summary":"The FDA and EMA usually agree but differ in timing and detail (the EMA is stricter on surrogate endpoints and single-arm data); the CHMP issues an opinion that the European Commission formalises about two months later. China's NMPA has approved dozens of domestic PD-1 antibodies and other drugs on China-only or conditional data that the FDA has rejected. Project Orbis (FDA-led) and the Access Consortium (UK, Canada, Australia, Singapore, Switzerland) share reviews to speed approvals; reliance pathways let smaller agencies adopt others' decisions. Regulatory fragmentation and the demand for multiregional trials are recognised bottlenecks for global access.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods"}],"tags":[],"related":["bla-nda","conditional-approval","hta"],"cancers":[],"sections":["drug-discovery"],"technologies":["project-orbis"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Regulation & policy"},"route":"/terms/regulatory-agencies/","neighbours":{"term":[{"id":"bla-nda","kind":"term","name":"BLA / NDA / MAA (marketing applications) and PDUFA dates","route":"/terms/bla-nda/"},{"id":"china-drug-administration-law","kind":"term","name":"China Drug Administration Law (2019) and expedited pathways","route":"/terms/china-drug-administration-law/"},{"id":"complete-response-letter","kind":"term","name":"Complete response letter (CRL)","route":"/terms/complete-response-letter/"},{"id":"conditional-approval","kind":"term","name":"Conditional marketing authorisation (EU)","route":"/terms/conditional-approval/"},{"id":"ethics-review","kind":"term","name":"Ethics review (IRB, research ethics committee)","route":"/terms/ethics-review/"},{"id":"fda-ldt-rule","kind":"term","name":"FDA laboratory-developed test (LDT) rule","route":"/terms/fda-ldt-rule/"},{"id":"fdca","kind":"term","name":"Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments","route":"/terms/fdca/"},{"id":"hta","kind":"term","name":"Health technology assessment (HTA), reimbursement and QALYs","route":"/terms/hta/"},{"id":"ilap","kind":"term","name":"ILAP (Innovative Licensing and Access Pathway)","route":"/terms/ilap/"},{"id":"india-new-drugs-rules-2019","kind":"term","name":"India New Drugs and Clinical Trials Rules 2019","route":"/terms/india-new-drugs-rules-2019/"},{"id":"ivdr","kind":"term","name":"IVDR (EU In Vitro Diagnostic Regulation 2017/746)","route":"/terms/ivdr/"},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/"},{"id":"medicines-medical-devices-act-2021","kind":"term","name":"Medicines and Medical Devices Act 2021","route":"/terms/medicines-medical-devices-act-2021/"},{"id":"odac","kind":"term","name":"ODAC (Oncologic Drugs Advisory Committee)","route":"/terms/odac/"},{"id":"project-orbis","kind":"term","name":"Project Orbis","route":"/terms/project-orbis/"},{"id":"eu-regulation-726-2004","kind":"term","name":"Regulation (EC) No 726/2004: the EU centralised procedure","route":"/terms/eu-regulation-726-2004/"},{"id":"sakigake","kind":"term","name":"Sakigake designation (Japan)","route":"/terms/sakigake/"},{"id":"trial-lifecycle","kind":"term","name":"Trial lifecycle: from protocol to label","route":"/terms/trial-lifecycle/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"person":[{"id":"emer-cooke","kind":"person","name":"Emer Cooke","route":"/people/emer-cooke/"}],"idea":[{"id":"idea-moon-unproven-clinic-registry","kind":"idea","name":"A public registry of unproven cancer clinics and reported outcomes","route":"/ideas/idea-moon-unproven-clinic-registry/"},{"id":"idea-tr1-exposure-response-before-dose-selection","kind":"idea","name":"Exposure-response modelling with a pre-set target exposure before any dose is chosen","route":"/ideas/idea-tr1-exposure-response-before-dose-selection/"},{"id":"idea-reg-single-global-dossier","kind":"idea","name":"One structured global dossier: submit the cancer drug file once, to a shared cloud","route":"/ideas/idea-reg-single-global-dossier/"}]}}