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On December 7, CDE issued the "Technical Guidelines for the Application of Biomarkers in the Clinical Research and Development of Anti-tumor Drugs", which will be implemented from the date of issuance
.
The original text is as follows: Announcement from the Center for Drug Evaluation of the State Food and Drug Administration on the issuance of the "Technical Guidelines for the Application of Biomarkers in the Clinical Development of Anticancer Drugs" (No.
53 of 2021) to guide the clinical use of anticancer drugs for the rational use of biomarkers R&D provides technical specifications that can be referred to.
Under the deployment of the National Medical Products Administration, the Center for Drug Evaluation has organized and formulated the "Technical Guidelines for the Application of Biomarkers in the Clinical Research and Development of Anti-tumor Drugs" (see appendix)
.
In accordance with the requirements of the "Notice of the General Department of the State Drug Administration on Issuing the Procedures for Issuing the 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
.
Hereby inform
.
Attachment: Technical guidelines for the application of biomarkers in the clinical research and development of anti-tumor drugs
