China
National Medical Products Administration (NMPA) · Asia-Pacific
Executive summary
China is the world's second-largest pharmaceutical market and is regulated by the National Medical Products Administration (NMPA) under the State Council. Drug review is performed by the Center for Drug Evaluation (CDE). The 2017 reforms (Opinions on Deepening the Reform of the Review and Approval System) and the revised Drug Administration Law (DAL, December 2019) transformed China from a slow, isolated regulator into one of the world's most aspirational reform programmes — implementing ICH guidelines (China joined ICH in 2017, became a Management Committee member in 2018), the Marketing Authorisation Holder (MAH) system, priority review, conditional approval, and acceptance of foreign clinical data. Foreign clinical data is now broadly accepted (with ethnic-sensitivity bridging where required) under the 2018 Notice 52 reforms, enabling truly global development plans. The MAH system delinks marketing authorisation from manufacturing, allowing virtual companies and CMO-based supply. The Volume-Based Procurement (VBP) programme, the National Reimbursement Drug List (NRDL) annual negotiations, and the Diagnosis-Related Group (DRG/DIP) hospital payment reforms have fundamentally reshaped pricing dynamics, driving deep price reductions for off-patent products and demanding sharp value-based pricing for innovative therapies.
About the authority
NMPA was established in 2018 (formerly CFDA, formerly SFDA) and reports to the State Administration for Market Regulation (SAMR) under the State Council. The Center for Drug Evaluation (CDE) conducts technical evaluation; the Center for Food and Drug Inspection (CFDI) handles GMP/GCP/GLP inspections; the National Institutes for Food and Drug Control (NIFDC) operates the national drug standards laboratory. The Center for Drug Re-evaluation (CDR) handles pharmacovigilance.
International affiliations
Reliance & recognition
China does not operate a formal reliance pathway equivalent to ACCESS or COR-A, but the 2018 Notice 52 reforms enable foreign clinical data to be accepted as primary evidence in Class 1/5.1 NDAs, eliminating the historic requirement for fully redone Chinese trials. Foreign GMP inspections are accepted on a case-by-case basis but Chinese inspection of overseas sites is increasingly common for imported drugs. The 2024 expansion permits more imported drugs to use foreign-only data where ethnic sensitivity is addressed.