Announcement of the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Guiding Principles of Real World Data Used to Generate Real World Evidence (Trial)
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In order to further guide and standardize sponsors to use real-world data to generate real-world evidence to support drug development, the Center for Drug Evaluation has formulated the "Guiding Principles for Real-World Data for Real-World Evidence (Trial)" (see attachment). In accordance with the requirements of the "Notice of the Comprehensive Department of the State Drug Administration on Printing and Distributing the Procedures for the Publication of Technical Guidelines for Drugs" (Yao Jian Zong Yao Guan [2020] No. 9), it is hereby issued with the approval of the State Drug Administration, as of the date of issuance From implementation.
announce.
Drug Evaluation Center of the State Drug Administration
April 13, 2021
Attachment 1: "Guiding Principles of Real-World Data Used to Generate Real-World Evidence (Trial)".pdf 
