CHINA DMF Consultant

CFDA – China Food and Drug Administration now known as NMPA- National Medical Product Administration is the responsible body for DMF- Drug Master File Registration in China. Since Jan 2018 China has been accepting DMF for Active Pharma Ingredient (API), Excipients, and Packing Material as part of Drug application Procedure only.

This change in system has shorten the approval time and cost involved in DMF approval. Now Pharmaceutical manufacture can use LOAs and refer to DMF while making their Drug Application.

CDE- Center for Drug Evaluation of NMPA is responsible for evaluation of DMF submission in CHINA.

1. Active Pharma Ingredient (API / Bulk Drug) Manufacturer
2. Excipient Manufacturer
3. Packaging material Manufacturer (like HDPE/PP Bottles, Vials, Ampoules, foils, Caps, CRC Caps etc.)

1. Appoint Local Agent for CHINA DMF or one should have a  subsidiary company
2. File Application form with CDE
3. Receive Registration Number
4. Draft the DMF as per CDE Requirement
5. Translate to Chinese Language
6. Send the complete application to CDE
7. CDE will review the Application
8. After Approval the DMF Number will be published on their website

If there is no local office or a subsidiary company in China for the applicant then CHINA agent acts as a local representative and point of contact for all communication. They are responsible for filing the DMF with CDE. Manufacturer and China Agent are equally responsible for the authenticity and integrity of the DMF.

On an Average CHINA DMF can be completed in a matter of 1- 4 months depending upon the technical information available with the manufacturer. For a more accurate timeline and to Plan your submission talk to FDApals now.

Currently there is no fees to be paid to CDE for DMF Registration for Excipient and Packaging Material.

Generally Single DMF is enough for 1 product unless the product is manufactured in a different site or the API has a different route of synthesis and manufacturing process.

API/excipient having difference in crystalline form or particle size, density, viscosity is generally allowed to be filled in single DMF.

Clerical mistake or inconsistent product or company name, address with the license and application form and the dossier.

Manufacturing license of the applicant has expired or is having near term expiry

DMF Application grossly lacking technical information like manufacturing process, critical process parameters, process flow chart etc. CDE might also raise supplementary information request if they find the data provided is inadequate.