To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply ICH Guideline E11A: Pediatric Extrapolation (hereinafter referred to as the E11A Guidelines). The relevant issues are hereby announced as follows:

1. The E11A Guidelines will apply to all relevant studies starting from November 18, 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

November 18, 2024