As China’s drug market grows exponentially, more foreign API, excipient and drug packaging material companies look to sell their products in China.
In August 2016, to simplify the drug review procedure, the former CFDA announced that the review and approval of APIs, excipients and pharmaceutical packaging materials will not be reviewed individually and will not be approved with a separate registration license. The excipients and pharmaceutical packaging materials will only be reviewed and evaluated jointly with the corresponding drug registration.
However, in 2018, the NMPA changed its tune and stated that a DMF is highly recommended for APIs, excipients and packaging materials, separate from the drug registration.
In July 2019, the NMPA announced further regulations on DMFs for APIs, excipients and packaging materials:
- The manufacturers of APIs, excipients and packaging materials shall file separate DMFs with the required technical dossiers;
- Overseas manufacturers shall authorize their domestic subsidiary or a China agent to file the DMF; both the manufacturer and agent are responsible for the authenticity and integrity of the filed dossiers;
- The manufacturer shall issue a Letter of Authorization to the applicant for the DMF;
- An annual report for APIs, excipients and packaging materials shall be submitted in the first quarter of every calendar year. Any changes of information shall be reported in the annual report and shall be notified to the drug manufacturer immediately when it happens.
Given the increased demand for DMFs, obtaining the registration number has slowed down. This slowdown has also been hindered by more CDE retirements over the last year or so.