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NMPA Announcement on Adopting ICH Guideline E9 (R1)

CCFDIE| Updated: 2021-01-25

To keep pace with the international technical standards for drug registration, the NMPA has decided to adopt the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guideline E9 (R1): Addendum on Estimands and Sensitivity Analysis in Clinical Trials. E9 (R1) shall be applicable to the drug clinical studies starting 12 months upon the issuance of this Announcement.

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.