To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline M12: Drug Interaction Studies and its Q&A document (hereinafter referred to as the M12 Guidelines and its Q&A document). The relevant issues are hereby announced as follows:

1. The M12 Guidelines and its Q&A document will apply to all relevant studies starting from October 29, 2024 (based on the time point of the trial record).

2. The relevant technical guidelines may be accessed on the website of the Center for Drug Evaluation of NMPA. The Center for Drug Evaluation of NMPA shall be responsible for relevant technical guidance during the implementation of this Announcement.

It is hereby announced.

National Medical Products Administration

October 29, 2024