On July 16, 2019, China NMPA issued the Announcement on Further Improving the Binding Review, Approval and Supervision of Drugs (Announcement No. 56, 2019), updating the requirements for the filing and binding review of APIs, excipients and pharmaceutical packaging materials. The content of the announcement is similar to the previous draft version for public opinions issued by NMPA in April 2019. With this new announcement, the Announcement No. 146, 2017 will be invalidated.
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. It is mentioned that “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”. Comparing 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. It clarifies the following conditions will be directly transferred to the DMF platform to give the filing number, and the “Active” status will be granted;
- APIs with the approval licenses and the expiration date is no earlier than November 27, 2017;
- APIs have 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 the expiration date is no earlier than August 10, 2016.
3. Add the case in which a separated review application is applicable: the APIs used for generics which the same drugs are already approved on the market. Which means, for these APIs, it’s workable to not wait for the binding review with finished drugs, but to submit a single application to be reviewed and approved. 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 is Q1 of each year, and the basic content is given (the template of annual report is still not available).
The new announcement will be implemented since August 15, 2019.