China DMF
filing for API,Pharmaceutical Excipients and Drug Packaging Materials
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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
Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and
Pharmaceutical Packaging Materials 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 Active Pharmaceutical
Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging
Materials 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 API,Pharmaceutical
Excipients and Packaging
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 ), Such Pharmaceutical products can be legal imported to china for Such
Pharmaceutical products can be imported to china for Domestic Finished dosage
form (FDF) Pharmaceutical manufacturers study use purpose ；
China's Domestic Finished dosage form (FDF) Pharmaceutical manufacturers 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 technical Complete Assessment,
can be imported to china for all purpose without any limit;
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;
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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