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 E8 (R1): General Considerations for Clinical Studies and E14: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs (hereinafter referred to as E8 (R1) and E14). The relevant items are hereby announced as follows:

　　1. The Guidelines E8 (R1) and E14 shall be adopted to the drug clinical trials initiated from July 31, 2023. From the date of implementation of Guideline E8 (R1), the Guideline E8 shall be revoked.

　　2. 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

　　August 1, 2022