Pharmaceutical Regulations in China

In China, Pharmaceuticals are regulated by The National Medical Products Administration (NMPA) is the Chinese agency for regulating drugs and medical devices (formerly known as the China Food and Drug Administration or CFDA).

Document Number Document Title Issued by Description Available Languages Download
- NMPA: List of the First Batch of Rare Diseases NMPA The NMPA has issued its first list of rare diseases at the national level in May 11, 2018 that outlined the rare diseases in China. English Complimentary
Order No.28 Administrative Measures for Drug Registration NMPA The Measures applies to the applications for drug clinical trial, drug production or import, and conducting drug approval, relevant testing for drug registration, or regulation thereof, within the territory of the People's Republic of China. English For Sale
Order No.04 Administrative Measures for Drug Importation NMPA These Measures shall apply to the registration of importation, customs declaration, port inspection and importation of pharmaceuticals. English For Sale
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