• The Drug Administration Law of the People’s Republic of China (2019 Revision),
• The Provisions for Drug Registration (2020 SAMR Decree No. 27).

DMF Filing Workflow Steps

1. After preparing a DMF dossier for product filing in China, the applicant could submit the application on CDE’s platform.
2. CDE will check the dossier is complete and accept the application if it identifies no areas for concern.
3. Once accepted, CDE issues an inactive filing number with the status “I” (inactive).
4. According to the requirements of Drug-related Associated review, the manufacturer of the finished dosage form must also submit a drug registration for review.
5. For a high-risk API, pharmaceutical excipient or packaging material, National Medical Products Administration (NMPA) will conduct a for-cause on-site inspection in the process of:

• Research,
• Development,
• Manufacture,
• Distribution,
• Use of the product.

The product will be reviewed based on the DMF dossier, the result of site inspection, and sample testing.