National Medical Products Administration / Center for Drug Evaluation

The National Medical Products Administration (formerly CFDA) and its Center for Drug Evaluation regulate medicines in China. Reforms beginning in 2015 cleared a backlog of applications, accepted overseas clinical data, introduced breakthrough, conditional and priority review pathways, and brought China into ICH in 2017, cutting approval times and enabling domestic companies to develop PD-1 antibodies, antibody-drug conjugates, bispecifics and CAR-T at pace. The CDE publishes technical guidelines including those on single-arm trials and oncology endpoints, and its decisions on domestic PD-1s, ivonescimab and Chinese ADCs are followed closely by global companies licensing Chinese assets. Reimbursement is decided separately through the National Reimbursement Drug List negotiations.