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China DMF filing for API,Pharmaceutical Excipients and Drug Packaging

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 API,Pharmaceutical Excipients and Packaging  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 API,Pharmaceutical Excipients and Packaging  pre-market approval policy that had implemented for more than ten years, Replaced by DMF (Drug Master Files) filing policy; The Foreign API,Pharmaceutical Excipients and Packaging  Manufacturers can export the products to china, no longer necessary to apply for Imported Pharmaceutical Product License in advance, it was really Expensive and time consuming ,usually need hundreds of thousands to million USD cost and need 2-8 years time;

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

After obtain the "The DMF filing acceptance notice " (that is,Pre-assignment DMF Numbers ), pharmaceutical 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 API,Pharmaceutical Excipients and Packaging  that only have Pre-assignment DMF Numbers for pupose of research ,or CFDA drug registration applications or change API,Pharmaceutical Excipients and Packaging  Supplementary application.

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

After the drug application pass CFDA approval, the API,Pharmaceutical Excipients and Packaging  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 Access (LOA) issued by the API,Pharmaceutical Excipients and Packaging  manufacturer, then CFDA can use the API,Pharmaceutical Excipients and Packaging  DMF data directly without the need for technical review again.

Pharmaceutical 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  
  • API: Imported Drug License (IDL)
  • Excipients:  Imported Pharmaceutical Excipient License (IPEL)
  • Packaging: Imported Drug Packaging License (IDPL)  
  • DMF Filing Number
    (DMF filing acceptance notice)
    Process time 
  • API: 3~8 years
  • Excipients: 2~5 years
  • Packaging: 1~3 years
  • Usually less than 1 year  
    Cost (USD)
  • API: $500K to $1 million 
  • Excipients: $100K to $500K 
  • Packaging:$50K to $100K 
  • Save more than 50%, Detail Inquire us for 
  • China DMF application inquiry form for API
  • China DMF application inquiry form for Pharmaceutical Excipient
  • China DMF application inquiry form for Pharmaceutical Packaging
  • Please download & fill this form then email us for inquiry

    Though China's new DMF registration process is very similar to the US Food and Drug Administration's (FDA) DMFs registration process, and the requirements for review of DMF application dossiers in China are more and more in accordance with ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), China CDE can accept applicant submitting a DMF dossiers using Electronic Common Technical Document (eCTD) too,

    But there are still a lots of differences and special local requirements of China DMF filing. You might waste much more time on supplement or recomposition of DMFs Application Dossier if you do not understand the special requirements of DMFs registration in China. Therefore, an experienced consulting agency is able to assist you to prepare the Application Dossier according to the requirements, and handle the registration procedure smoothly.

    The CFDA requires that all Pharmaceutical companies which located out of China must appoint a registered Chinese Responsibility Agent (CRA). Appointed CFDA CRA must be a legal entity and maintain a place of business in China. RJS MedTech. Inc. is eligible to be your CRA in China.

    We are engaged in the fields of pharmaceutical products CFDA registration consulting service more than 15 years, help many foreign pharmaceutical manufacturers enter Chinese market. we know how to guide the pharmaceutical manufacturer on preparation of CFDA DMF Application Dossier, and avoidance of failures and defects in registration procedure, Help foreign pharmaceutical manufacturer obtained DMF registration number successfully!


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