Since January 1, 2018, CFDA has not been accepting Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials registration application independently. The Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials are now reviewed/approved as part of a drug product application.
Who Can File a Drug Master File (DMF)?
The following category of companies intending to export to Chinese drugs manufacturers can file the DMF
- Active Pharmaceutical Ingredients manufacturers
- Excipient manufacturers
- Packaging Material manufacturers
Why File a DMF?
Several countries mandate submission of DMF. Obtaining a DMF number helps in simplifying dossier review for finished products easier for health agency since they can review the DMF number for the API, excipient or packaging material that is already approved. Obtaining a DMF number also helps manufacturers to protect their intellectual property from licensing partners who use their proprietary APIs, excipients or packaging material for manufacturing finished products.
What is the Process for Filing the DMF?
- Register with CDE Platform
- Fill the DMF Application Form
- Obtain Registration Number
- Mail CD Version dossier to CDE
- CDE Review and Approval
- DMF Information is posted publicly by CDE
What are the Documents Required for DMF Registration in China?
1.Company Basic Information such as name, registration details etc.
- Basic information of pharmaceutical package materials such as package name, composition and ingredients (all ingredients) with information on physical and chemical properties, basic characteristics of the package, protective and functional features.
- Current approval and marketing situation in China and overseas with relevant supporting documents, summary of production, sales and usage
- Include National Standard and Pharmacopeia Record information (Domestically and Overseas)
- Manufacturing information such as production process and process control, material control, key procedures, verification, validation and evaluation
- Documents related to quality control, quality standard, analytical method validation and related documents
- Documents related to patch testing and reports, stability analysis
- Provide safety and comparability analysis study reports
Artixio is an integrated compliance, commercial, creative and communication company that offers generic drugs, APIs, excipient manufacturers with Drug Master File (DMF) registration services in China. Using our regional teams, we provide legal representation, license holding, NMPA interactions and negotiation services in China.
For more details, write to us at firstname.lastname@example.org