China DMF Inactive Number by CDE. Complete but not approved.

China DMF Active Number by CDE. Activated/Approved.

 

For Drug master filing (DMF) in China, there is a new guideline released by China’s NMPA (Formerly CFDA) in 2019 for the scope of active pharmaceutical ingredients (APIs), excipients and packaging materials. Similar to the systems of US DMF, Canadian DMF and EU CEP, the new guideline helps protect manufacturers from disclosing confidential information to their distributors and specifies a more direct route to communicating with China health authorities, e.g., Center for drug evaluation (CDE).

Applicants who already have US DMF, Canadian DMF and EU CEP will benefit from overlapping data, although they’re differences in local data requirements.

The new DMF filing system in China helps protect the supplier from disclosing unnecessary confidential data to the drug applicant which enables a direct path to exchange communication with China’s health authority namely Centre for drug evaluation (CDE).

What are inactive and active DMF numbers in China?

The applicant prepares China DMF dossier and file application to CDE for completeness review for allocation of DMF filing number with a status of “I” for “Inactive”.

Upon drug product registration, for example ANDA or new drug application; CDE will refer to the inactive DMF filing number and review the DMF dossier together with the drug dossier and then activate the DMF filing number shown as “A” for active. The “I” and “A” status will officially display on CDE database.

Steps to File DMF in China

The 7 steps for DMF filing process to obtain inactive and active DMF filing number is displayed in the flow graph above and correspondingly explained below:

The general steps for DMF filing include obtaining inactive and active filing number described below:
Step 1: Check material completeness to identify if the materials are generally complete.
Step 2: Conduct a more detailed data-gap analysis, providing guidance on supplementing missing data according to China CDE requirements.
Step 3: Prepare a DMF dossier in Chinese and file to CDE.
Step 4: CDE reviews dossier for completeness and feedback in 1 to 2 weeks.
Step 5: CDE issues the Inactive filing number in around 3-6 months counting from step 2 data gap analysis.
Step 6: CDE performs technical review. The queuing time at CDE may differ depending on the actual situation. It was slightly longer due to Covid-19 but now recovered back to normal processing times.
Step 7: CDE usually takes from start to finish 6-12 months for the technical review and will activate the DMF filing number If the finished product has already been approved.

Checklist for DMF filing in China

Costs & Timelines for DMF in China

China DMF Compared with US DMF, EU ASMF & CEP

 

Authorised Agent in China

Accestra Consulting has successfully helped overseas manufacturers to file drug master files (DMF) in China. We can be your trusted appointed agent by issuing us a letter of authorisation (LoA).

• Find out more about China Drug Master file (DMF) Regulations and standards

We would be more than happy to arrange a teleconference call you share an overview of the China DMF process, requirements, costs and timelines. Email us to arrange a date and time to call (Info@accestra.com).

China Drug Master File (DMF) for APIs, packaging Materials, and pharmaceutical excipients are regulated by China NMPA formerly CFDA. The related DMF regulations and standards clarify the drug master file structure, process, requirements, timelines, and costings in the regulations listed below.

Contact Accestra Consulting Group for English translations or questions on China’s Drug Master File (DMF) requirements.

General Laws

Drug Administration Law (2019 No. 31)

The regulatory basis for the development, manufacture, business operation, practical use, supervision, and administration of drug products, substances, excipients, and packaging materials.

• https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html (Chinese)

Provisions for Drug Registration (2020 No. 27)

The regulatory basis for DMF approval pathways in Section 3 of Chapter 3.

• https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/fgwj/bmgzh/20200330180501220.html (Chinese).

DMF Standards

Announcement for Adjusting Evaluation and approval for APIs, Excipients and Packaging Materials (2017 No. 146)

Basic requirements for the binding review and approval of a drug and its related APIs, excipients, and packaging materials.

• https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20171130163301730.html (Chinese).

Announcement on Issues Concerning the Further Improvement of Drug-related Associated Review & Approval and Supervision (2019 No. 56)

Detailed requirements for DMF filing, incl. scope of DMF, dossier requirements, filing process and timeline under the framework of binding review and approval.

• https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20190716174501955.html (Chinese).

Provisions for Administration of Drug-related Associated Review & Approval for APIs, Excipients and Packaging Materials (2020 Draft for Comments)

Comprehensive administrative practices of DMF filing, incl. API independent review & approval, DMF holder responsibilities & obligations, changes to approved DMFs, and product supervision by the authorities.

• http://www.cde.org.cn/news.do?method=largeInfo&id=5561f130fad55ba4 (Chinese).