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On December 7, CDE issued the "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-coronavirus Chemical Drugs (Trial)" and "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-coronavirus Pneumonia Drugs (Trial)" The "Technical Guidelines for Non-clinical Research on Novel Coronavirus Neutralizing Antibody Drugs (Trial)" will come into effect on the date of issuance
.
The original text is as follows: In view of the occurrence and development of the domestic and international new crown epidemic and the needs of clinical treatment, anti-new crown virus chemical drugs, treatment of new crown virus pneumonia inflammation drugs and new crown virus neutralizing antibody drugs have become the focus of anti-epidemic drug development and review
.
In order to guide drug research and development, the Center for Drug Evaluation has organized and formulated the "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-New Coronavirus Chemical Drugs (Trial)" and "Technical Guidelines for Non-clinical Pharmacodynamic Research and Evaluation of Anti-Coronavirus Pneumonia Inflammatory Drugs" (Trial) "Technical Guidelines for Non-clinical Research of Novel Coronavirus Neutralizing Antibody Drugs (Trial)" (see Annex 1-3)
.
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
.
Attachment: 1.
Technical guidelines for non-clinical pharmacodynamic research and evaluation of anti-coronavirus chemical drugs (trial implementation) 2.
Technical guidelines for non-clinical pharmacodynamic research and evaluation of anti-coronavirus pneumonia inflammatory drugs (trial implementation) 3.
Novel coronavirus Technical guidelines for non-clinical research on neutralizing antibody drugs (for trial implementation)
