On 16 July 2019, the China NMPA issued the Announcement on Further Improving the Binding Review, Approval and Supervision of Drugs (Announcement No. 56, 2019).
This included updates to requirements for the filing and binding review of APIs, excipients, and pharmaceutical packaging materials.
With this new announcement, Announcement No. 146, 2017 will be invalidated.
What changes are being made to China DMF
According to Announcement No. 56, 2019, China continues to implement the “individual filing, binding review” way for APIs, excipients and pharmaceutical packaging materials, and the new adjustments include the following:
1. “If the APIs/excipients/pharmaceutical packaging materials is not able to be registered on the platform for special reasons, the information of APIs/excipients/pharmaceutical packaging materials is also allowed to submit together with the finished drug application dossier”.
Compared to the previous description in Announcement No. 146, 2017 “only the APIs, excipients and packaging materials for self-use or designed for specific finished drug holders, may submit the information together with the drug application dossier instead of the separated filing”, the filing of APIs/excipients/pharmaceutical packaging materials is no longer mandatory, which means the joint submission with the finished drug is generally acceptable.
2. The following conditions will apply to the DMF platform. to A filing number will be produced and an “Active” status granted;
- APIs with the approval licenses and expiry date no earlier than November 27, 2017;
- APIs completed for review, including the API transfer application reviewed by the provincial bureau in accordance with the NMPA No. 38 Notice, 2013;
- Excipients and pharmaceutical packaging materials that have completed for review;
- Excipients that have obtained approval licenses;
- Pharmaceutical packaging materials with approval licenses and expiry date no earlier than August 10, 2016.
3. Add the case in which a separated review application is applicable: the APIs used for generics in which the same drugs are already approved on the market. For these APIs, it’s possible to bypass the binding review with finished drugs. A single application can be submitted for review and approval instead. After that, the status of the APIs will also be changed to “Active”;
4. Update the filing data requirements for excipients and pharmaceutical packaging materials;
5. A list of excipients is issued, including the names of certain flavors, essences, pigments, inorganic salts, pH regulators, and benzene free ink for printing which can waive the filing work to China NMPA ;
6. Clarify the time of annual report submission for APIs/excipients/packaging materials companies in Q1 of each year, and the basic content is given (the template of the annual report is still not available).
The new announcement came into effect on 15 August 2019.