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Breaking News! The Center for Drug Evaluation of the National Medical Products Administration has issued the Notice on the Publication of the “Technical Guidance Principles for Clinical Safety Evaluation of New Drugs” (No. 59 of 2023).


Clinical safety evaluation of new drugs is an essential foundation for assessing the benefit-risk profile of these drugs. To provide scientific methodologies and technical guidance for clinical safety evaluation of new drugs, the Center for Drug Evaluation has developed the “Technical Guidance Principles for Clinical Safety Evaluation of New Drugs” (see attachment).
In accordance with the "Notice of the Comprehensive Division of the National Medical Products Administration on Issuing the Procedures for Publishing Pharmaceutical Technical Guidance Principles" (NMPA Comprehensive Drug Administration [2020] No. 9), and following review and approval by the National Medical Products Administration, this document is hereby released and shall take effect from the date of its publication.
Hereby notified.
Attachment: Technical Guidance Principles for Clinical Safety Evaluation of New Drugs
 

Center for Drug Evaluation, National Medical Products Administration

December 1, 2023

Related attachments

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     1 Technical Guidance Principles for Clinical Safety Evaluation of New Drugs.pdf

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