To align the technical standards for drug registration with international standards, the National Medical Products Administration has decided to adopt 13 ICH safety guidelines, including S1A: Need for Carcinogenicity Studies of Pharmaceuticals (see the attachment for further information).  

Items of the Announcement are as follows.

I. The sponsors shall conduct research in accordance with the ICH guidelines as soon as possible on the basis of the existing technical requirements. The 13 ICH safety guidelines shall be adopted for non-clinical studies starting from May 1, 2020, and the starting dates of non-clinical studies shall be determined in accordance with the relevant provisions of the Good Laboratory Practice (GLP).

II. The relevant safety guidelines are available on the official website of the Center for Drug Evaluation of the NMPA. The Center for Drug Evaluation of the NMPA is responsible for technical guidance in the implementation of the Announcement.

Attachment: 13 ICH safety guidelines to be adopted

National Medical Products Administration

November 5, 2019