China Drug Master File (DMF) – Do you still know what’s going on?

6 September, 2019

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?

Our experienced project managers working in China DMF projects have developed particular strategies to manage projects. Please do not hesitate to get in touch with our experts if you have questions regarding your role under the National Medical Products Administration Regulation. Our experts will accompany you on your challenging journey.

Dr. Xiaohua He Managing Director
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