Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)
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.