China Drug Master File Overview
- Active Pharmaceutical Ingredients (APIs),
- Pharmaceutical excipients and packaging materials.
China DMF Filing Process
- To register for DMF filing you need to submit an application dossier to China’s Center for Drug Evaluation (CDE).
- They will review your application for documentation completeness and you will get an inactive filing number within 5-10 working days.
- The dossier will then be reviewed together with the dossier of the related finished dosage form (Drug-related Associated Review) to get the activated filing number.
Does China DMF comply with US FDA or EU EMA Requirements?
China DMF Summary
DMF Policy Update (August 2019)
On July 16, 2019, China NMPA published the new DMF requirements (Announcement No. 56 of NMPA, 2019), which was a major update to DMF filing for APIs, pharmaceutical excipients & packaging materials.
Key takeaways of the new requirements are below:
- Risk-based evaluation for excipients and packaging materials.
- Annual report being submitted every first quarter of the year.
- List of excipients no longer required.
- Previously approved APIs in China are exempted from drug-related associated review.
- Dossier requirements and workflow simplified.
- Find out more about the DMF policy update.
Is China DMF ECTD Ready?
- Pharmaceutical excipients,
- Packaging materials.
Announcement No. 146, 2017 (published by the former China Food and Drug Administration (CFDA))
Announcement No. 56, 2019 (issued by China National Medical Products Administration (NMPA))