In order to further guide and standardize sponsors to use real-world data to generate real-world evidence to support drug research and development, the Center for Drug Evaluation, NMPA organized the formulation of the Guiding Principles for Real-World Data Used to Generate Real-World Evidence (Trial) (see Annex). According to the requirements of the Notice of the Comprehensive Division of the National Medical Products Administration on Printing and Distributing the Procedures for Issuing Technical Guiding Principles of Drugs (YJZYG [2020] No.9), upon approval by the National Medical Products, it is hereby promulgated and shall come into force as of the date of promulgation.

It is hereby announced.

Center for Drug Evaluation, NMPA

April 13, 2021

Annex 1: Guiding Principles for Real-World Data Used to Generate Real-World Evidence (Trial).pdf

(Please click on the link to read the Annex: http://www.camdi.org/news/9883)