On May 15, 2026, China’s National Medical Products Administration (NMPA) officially announced the final Measures for the Implementation of Drug Trial Data Protection1 (“Measures”), effective May 15, 2026. These Measures provide important details supporting the recently announced Implementing Regulations of the Drug Administration Law (“Regulations” – also effective May 15, 2026), which formally introduced a statutory market exclusivity of up to 7 years for qualifying orphan drugs, up to 2 years for pediatric drugs, and up to 6 years data exclusivity for “new chemical entity drugs and other drugs”. Key Highlights Under the finalized Measures, the NMPA2 grants a maximum regulatory data protection (“RDP”) period of up to 6 years…
