Drug Master File (DMF) in China

Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application.

Before called CFDA, now the National Medical Products Administration (NMPA) had a pre-market approval policy that allowed APIs, excipients and packaging materials to be registered separately with pharmaceutical product application. The process usually took longer and was more expensive. The new system allows these manufacturers to file the DMF reducing the approval time and respective cost involved. Pharmaceutical manufacturers can refer to the DMF code while submitting the drug application making the process more efficient.

Who Can File a Drug Master File (DMF)?

The following category of companies indenting to export to Chinese drugs manufacturers can file the DMF :
– Active Pharmaceutical Ingredients manufacturers
– Excipient manufacturers
– Packaging Material manufacturers

What is the Process for Filing the DMF?

NMPA has established an electronic platform for APIs, excipients and pharmaceutical packaging DMFs submission and registration. 

Does DMF Application need a Local Representative?

Yes, in order to file the DMF in China with NMPA, a manufacturer will require a local legal representative. The DMF application need to be filed in Chinese Language; therefore, if foreign manufacturers have their DMF in English or other language, they need to get the document translated in Chinese as per NMPA guidelines and format.

 

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