Contact us to learn how we can help you with DMF registration in China.
API, excipient, and drug packaging manufacturers that want to protect their intellectual property and manufacturing processes will want to do a China DMF. Manufacturers with EU CEP, US DMF, or Canadian DMF will already have a lot of the information required for a Chinese DMF. Once a DMF application is submitted and accepted by the CDE, a DMF number will be granted. It usually takes several months to get a DMF number, which will be classified as “inactive”. Once the final drug dossier is reviewed and approved, the DMF will become “active”. Normally for DMF activation, APIs take about 12 months, and excipients and drug packaging materials take less time. To submit a China DMF, you will need a local agent located in China. Annual DMF reports, including any changes, are due in the first quarter of the next year. PBM can act as your local agent for China DMFs.
The process to get a China DMF is as follows:
- Confirm that the API, excipient, or drug manufacturer has sent you the required documents (please see the list below)
- Do a gap analysis for missing documents
- Clarify outstanding issues or concerns
- Translate the DMF dossier into Chinese
- The Chinese CDE reviews the dossier to ensure all required documents are provided
- If the dossier is accepted, a DMF number will be issued (inactive DMF)
- After a technical review of the DMF dossier is completed with the drug application, and if the drug is approved, the DMF will now be “activated”
DMF requirements for APIs:
- Manufacturer
- General information of drug substances
- Manufacturing information
- Special nature evaluation
- Quality control
- Control substance
- Packaging materials and containers
- Stability data
- Packaging specification
- Patent situation
- Contact information
- Information on any third-party lab
- Commitment letter
- Other supportive information
DMF requirements for excipients and packaging materials:
- Manufacturer
- General information of excipient
- Manufacturing information
- Special nature evaluation
- Quality control
- COAs
- Stability data
- Safety and compatibility study
- Route of administration
- Strength/weight/size
- Packaging materials
- Packaging size
- Patent status
- Contact information
- Commitment letter
- Other supportive information
While there had not historically been any government fees for DMFs for APIs, excipients, and drug packaging materials, this changed in 2020. In March 2020, the NMPA announced that they were now charging API manufacturers an activation fee (including the administrative evaluation and review process) of about $50,000 to process a DMF and get approval for an API.
Currently, there are still no government fees for DMFs for excipients or drug packaging materials.
Contact us to learn how we can help you with DMF registration in China.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.