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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.
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.
Shares Sakigake designation (Japan), Japan conditional early approval and time-limited approval, ILAP (Innovative Licensing and Access Pathway), BLA / NDA / MAA (marketing applications) and PDUFA dates.
Shares Japan conditional early approval and time-limited approval, Conditional marketing authorisation (EU), Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments, BLA / NDA / MAA (marketing applications) and PDUFA dates.
Shares ODAC (Oncologic Drugs Advisory Committee), Japan conditional early approval and time-limited approval, Conditional marketing authorisation (EU), Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments.
Shares Complete response letter (CRL), Japan conditional early approval and time-limited approval, Conditional marketing authorisation (EU), Trial lifecycle: from protocol to label.
Shares Conditional marketing authorisation (EU), ILAP (Innovative Licensing and Access Pathway), Regulation (EC) No 726/2004: the EU centralised procedure, Health technology assessment (HTA), reimbursement and QALYs.
Shares Sakigake designation (Japan), China Drug Administration Law (2019) and expedited pathways, ILAP (Innovative Licensing and Access Pathway), BLA / NDA / MAA (marketing applications) and PDUFA dates.
Shares Project Orbis, India New Drugs and Clinical Trials Rules 2019, China Drug Administration Law (2019) and expedited pathways.
Shares ODAC (Oncologic Drugs Advisory Committee), Conditional marketing authorisation (EU), Regulation (EC) No 726/2004: the EU centralised procedure.