To keep pace with the international technical standards for drug registration, the NMPA has decided to adopt two guidelines of ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), including S5 (R3): Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals and S11: Nonclinical Safety Testing in Support of Development of Pediatric Pharmaceuticals (hereinafter referred to as S5 (R3) and S11).

Guidelines S5 (R3) and S11 shall be applicable to the non-clinical studies starting upon issuance of this Announcement. The designation of the starting date of nonclinical study shall be in accordance with the relevant provisions specified in the Good Laboratory Practice.

The relevant technical guidelines may be accessed on the website of the Center for Drug Evaluation of NMPA. The CDE of NMPA shall be responsible for effective technical guidance in relation to the implementation of this Announcement.

It is hereby announced.