To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines S1B (R1): Testing For Carcinogenicity of Pharmaceuticals and E14/S7B Q&A: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential (hereinafter referred to as S1B (R1) and E14/S7B Q&A). The relevant items are hereby announced as follows:

　　1. Applicants can carry out research based on the current S1 guidelines and refer to the recommendations of S1B (R1) guidelines; The relevant research initiated from March 22, 2023 shall be subject to the S1B (R1) guidelines. Meanwhile, the S1A, S1B, and S1C (R2) guidelines still prevail. The start time of research shall be determined in accordance with the relevant provisions of the Good Laboratory Practice for Non-Clinical Studies (GLP).

　　2. The E14/S7B Q&A shall be adopted to the drug clinical trials initiated from July 31, 2023.

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

　　National Medical Products Administration

　　March 20, 2023