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API export China new way - Apply DMFs (Drug Master Files) CNDA filing ,Save 80% Cost & Time of IDL !


Before 2018, APIs (active pharmaceutical ingredients) is same as preparations drugs, APIs are required to obtain IDL (import drug license) issued by China Food and Drug Administration(CFDA) before they can be imported into China. China CFDA IDL applications generally need three procedures.
Phase 1. Application for clinical trial permit(CTP);
Phase 2. Implementation of clinical trials;
Phase 3. Application for IDL;

The whole process usually takes about 5-8 years and the cost usually more than 1 million dollars, Even the generic API still need 3-5 years time for the IDL application, That is a very expensive and time-consuming process, blocking more than 95% of the pharmaceutical companies export their APIs to China. especially APIs from developing countries, such as India's API

On Nov. 23, 2017, China Food and Drug Administration(CFDA) issued a new 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)  ̄, Since Jan. 1,2018, China National Drug Administration(CNDA)won't accept pharmaceutical excipient registration application alone, the approval of API  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 CNDA has cancelled the API  pre-market approval policy that had implemented for more than ten years, Replaced by DMF (Drug Master Files) filing policy; The Foreign API  Manufacturers can export the products to china, no longer necessary to apply for Imported Pharmaceutical Product License in advance;

According to the new DMF filing regulation; Relevant APIs pharmaceutical manufacturers only need submit APIs  filing dossies (ie, DMFs-Drug Master Files) to CDE (Centre for Drug Evaluation of the China Food and Drug Administration) After passing the administrative review of CDE, 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 APIs to China's preparation drug manufacturer and export to China;

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

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

After the drug application pass CNDA approval, the API  will automatically pass the CNDA approval, obtain the official DMF registration number;

The Subsequent preparation drug manufacturer who apply for drug CNDA registration, will only need to obtain the Letter of Access (LOA) issued by the APIs  manufacturer, then CNDA can use the APIs  DMF data directly without the need for technical evaluation again.

Pharmaceutical manufacturers, after obtaining the DMF registration number, need submit annual product quality management reports to CNDA 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  
Certificate 
  • API: Imported Drug License (IDL)
  • DMF Filing Number
    (DMF filing acceptance notice)
    Process time 
  • API: 3~8 years
  • Usually less than 1 year  
    Cost (USD)
  • API: $500K to $1 million 
  • Save more than 50%, Detail Inquire us for 
  • China DMF application inquiry form for API
  • Please download & fill this form then email us for inquiry

    Though China's new API  DMF registration process is very similar to the US Food and Drug Administration's (FDA) DMFs registration process, and the requirements for review of API  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 API DMF dossiers using Electronic Common Technical Document (eCTD) too,

    But there are still a lots of differences and special local requirements of China API  DMF filing. You might waste much more time on supplement or recomposition of API  DMFs Application Dossier if you do not understand the special requirements of API 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 CNDA requires that all Pharmaceutical companies which located out of China must appoint a registered Chinese Responsibility Agent (CRA). Appointed CNDA 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 CNDA DMF Application Dossier, and avoidance of failures and defects in registration procedure, Help foreign pharmaceutical manufacturer obtained API DMF registration number successfully!

     
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