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China DMF filing for Pharmaceutical Excipients

China DMF filing for Pharmaceutical Excipients

According to the new CFDA regulations, ^Announcement of the CFDA on Adjusting Matters Concerning the Review and Approval of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146, 2017)  ̄, promulgated on Nov. 23, 2017; Since Jan. 1,2018, CFDA won't accept pharmaceutical excipient registration application alone, the approval of pharmaceutical excipients will be switched from the former system of separate approvals to a process whereby excipients are reviewed/approved as part of a drug product application.

That mean CFDA has cancelled the pharmaceutical excipients pre-market approval policy that had implemented for more than ten years, Replaced by DMF (Drug Master Files) filing policy; The Foreign Pharmaceutical Excipients Manufacturers can export the products to china, no longer necessary to apply for IDEL (Imported Pharmaceutical Excipients License) in advance, it was really Expensive and time consuming ,usually need hundreds of thousands USD cost and 3-5 years time ;

According to the new DMF filing regulation; Relevant pharmaceutical excipients manufacturers only need submit pharmaceutical excipients filing dossies (ie, DMFs-Drug Master Files) to CFDA After passing the administrative review of CFDA, they can obtain a "The pharmaceutical excipients filing acceptance notice " (that is,Pre-assignment of DMF Numbers );

After obtain the "The pharmaceutical excipients filing acceptance notice " (that is,Pre-assignment DMF Numbers ), pharmaceutical excipient manufacturers can sell their products to China's preparation drug manufacturer and export to China;

China's preparation drug manufacturer can choose to use the pharmaceutical excipients that only have Pre-assignment DMF Numbers for pupose of research ,or CFDA drug registration applications or change pharmaceutical excipients Supplementary application.

When the first China's preparation drug manufacturer that use this pharmaceutical excipients, submit the drug registration applications or change pharmaceutical excipients Supplementary application to CFDA. Then CFDA will Technical Review /Assessment the pharmaceutical excipients DMF dossier with the drug application dossier together, (also called binding review)

After the drug application pass CFDA approval, the pharmaceutical excipients will automatically pass the CFDA approval, obtain the official DMF registration number;

The Subsequent preparation drug manufacturer who apply for drug CFDA registration, will only need to obtain the letter of authorization(LOA) issued by the pharmaceutical excipients manufacturer, then CFDA can use the pharmaceutical excipients DMF data directly without the need for technical review again.

Pharmaceutical excipient manufacturers, after obtaining the DMF registration number, need submit annual product quality management reports to CFDA to keep their DMF registration numbers active;

ITEMS Pre-market Approval System DMF filing system
Implement Date  Before Jan. 1,2018   After Jan. 1,2018  
Cost  $100K to $500k  Inquire us for 
Process time  2-5 years   Usually less than 1 year  
Certificate  IDEL
(Imported Pharmaceutical Excipient License)  
DMF Filing Number
Pharmaceutical excipients filing acceptance notice  

Please download & fill the below inquiry form then email us:
  • China DMF application inquiry form for Pharmaceutical Excipient
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