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Registration Process of DMF Filling System

Source:
2019/12/24 09:29
[Abstract]:
An brief illustration for those who may need

I.Brief introduction:

According to the new NMPA regulations, “Announcement of the NMPA 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, NMPA 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.

 

It means NMPA has cancelled the API, Pharmaceutical Excipients and Packaging pre-market approval policy that had implemented for more than 10 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, which is really Expensive and time consuming ,usually need hundreds of thousands to million USD cost and need 2-8 years’ time;

 

II. Registration Process:

1.     Submit API, Pharmaceutical Excipients and Packaging filing dossiers (ie, DMFs-Drug Master Files) to NMPA;

 

2.     After passing the administrative review of CFDA, they can obtain a "The DMF filing acceptance notice " (that is, Pre-assignment of DMF Numbers);

 

3.     Then such Pharmaceutical products can be legal imported to china for Domestic Finished dosage form (FDF) Pharmaceutical manufacturers study use purpose;

 

4.     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 purpose of research, or NMPA drug registration applications or change API, Pharmaceutical Excipients and Packaging Supplementary application.

 

5.     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 NMPA. NMPA will Technical Review /Assessment the API, Pharmaceutical Excipients and Packaging DMF dossier with the drug application dossier together, (also called binding review)

 

6.     After the drug application pass NMPA approval, the API, Pharmaceutical Excipients and Packaging will automatically pass the NMPA technical Complete Assessment, can be imported to china for all purpose without any limit;
 

Attention:
The Subsequent preparation drug manufacturer who apply for drug NMPA registration, will only need to obtain the letter of Access (LOA) issued by the API, Pharmaceutical Excipients and Packaging manufacturer, then NMPA 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 NMPA to keep their DMF registration numbers active;

 

III. Comparison between old and new system

 

Item Pre-market Approval System DMF Filling System
Implement Date Before Jan. 1,2018 After Jan. 1,2018
Certificate

· 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

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