Drug Master File (DMF) in China

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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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According to the regulations under the jurisdiction of the China Food and Drugs Administration (CFDA), CFDA has cancelled the pharmaceutical excipients pre-market approval policy that applied for more than 10 years. It was replaced by the Drug Master Files (DMF) filing policy. That means, foreign manufacturers who export products to China do not need to apply for the Imported Pharmaceutical Excipients License (IDEL) any longer, but will need to take different action (see below). CFDA also changed the name to the National Medical Products Administration (NMPA).
Under the DMF filing regulation, pharmaceutical excipients manufacturers and/or Pharmaceutical Packaging Materials manufacturers need to submit the required information to NMPA to obtain the registration number for the "pharmaceutical excipients” and/or “pharmaceutical packaging materials” in order to sell their products to China's preparation drug manufacturers or export to China. The NMPA will review and assess the DMF dossier with the drug application dossier together. After the drug application passes NMPA approval, the pharmaceutical excipients and pharmaceutical packaging materials referred to will automatically pass the NMPA approval, and the status of those DMF registrations will be turned active. Then the registered pharmaceutical excipients and/or pharmaceutical packaging materials manufacturers need to submit annual product quality management reports to NMPA to keep their DMF registration numbers active. Any changes should be reported in the annual report. The NMPA requires that all foreign pharmaceutical companies must appoint a registered Chinese responsibility agent to handle the works. 
How do you make sure that all requirements are taken into account? How do you maintain an overview? How do you focus on ensuring product conformity while creating the corresponding documentation with maximum efficiency at the same time?


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