For help registering your DMF in China, please contact us to discuss your needs in more detail.
China is now the second-largest drug market in the world. If API, excipient, drug packaging manufacturers do not want to relinquish their manufacturing trade secrets during drug registration in China, they can submit a Drug Master File (DMF).
The main regulatory bodies for China DMFs are the Chinese NMPA and the Center for Drug Evaluation (CDE). In 2019, the NMPA issued the Announcement on – Improving the Associated Review and Approval and Supervision of Drugs. Chinese DMFs generally follow the regulations from this announcement.
To register a Chinese DMF, a foreign company needs to submit a dossier via a Chinese local agent. Not all DMF information is made public. Only the product name, DMF number, local agent and manufacturer name, active or inactive status, etc. are available online. All Chinese DMFs which receive DMF numbers must submit an annual report within the first quarter of the next year. This annual report will include any changes made during the previous year to the DMF.
Both administrative and technical documentation must be complete for the CDE to designate a DMF number and approval. Please click here to learn what is required for a DMF dossier. Each API, excipient, and drug packaging product usually requires its own DMF. However, in some cases, similar APIs, excipients, and drug packaging materials can be filed in the same DMF. APIs, excipients, or drug packaging materials manufactured at different sites need separate DMFs. DMFs can be declined by the Chinese government for a variety of reasons, including manufacturers not willing to provide confidential information, expired licenses, inconsistencies among documents regarding the company address, abbreviations, etc.
Recently, additional regulations have been enforced with API DMFs. Now, in addition to the CDE, the China National Institute for Food and Drug Control (NIFDC) will test the sample products’ analytical procedures and specifications locally in China. Normally, the Chinese lab will require 3 separate sets of samples to be tested. Not all APIs will experience local testing in China, but high-risk APIs will. Some API manufacturers prefer to get their DMF activated in China before their DMF is activated during the final drug review, so they can sell their API earlier to other finished drug manufacturers too.
For help registering your DMF in China, please contact us to discuss your needs in more detail.
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.