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. www.artixio.com

1. DMF Registration in China
www.dmfregistration.com/

2. Who Can File a Drug Master File (DMF)?
The following category of companies indenting to export to Chinese
drugs manufacturers can file the DMF
• Active Pharmaceutical Ingredients manufacturers
• Excipient manufacturers
• Packaging Material manufacturers

3. What is the Process for Filing the DMF?

4. Documents Required for DMF Registration in
China
1.Company Basic Information such as name, registration details etc.
2. 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.
3. Current approval and marketing situation in China and overseas with relevant supporting
documents, summary of production, sales and usage
4. Include National Standard and Pharmacopeia Record information (Domestically and
Overseas)
5. Manufacturing information such as production process and process control, material
control, key procedures, verification, validation and evaluation
6. Documents related to quality control, quality standard, analytical method validation and
related documents
7. Documents related to patch testing and reports, stability analysis
8. Provide safety and comparability analysis study reports