To keep pace with the international technical standards for drug registration, the NMPA has decided to recommend the application of ICH Guideline E9 (R1): Estimands and Sensitivity Analysis in Clinical Trials. E9 (R1) will be applicable to clinical studies of drugs initiated after 12 months from the date of issuance of this Announcement on January 21, 2021. 

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