CDE issues the 'Technical Guidelines for Pharmacological Changes Research of Listed Traditional Chinese Medicines (Trial)'
2021-07-09 00:00
In accordance with the "State Council's Opinions on Reforming the Drug and Medical Device Review and Approval System" (Guo Fa [2015] No. 44) and the "Regulations on Drug Registration Management" (Order No. 27 of the State Administration for Market Regulation) and other relevant regulations, in order to further implement the relevant requirements of drug review and approval reform and to deeply advance the public disclosure of review information, under the deployment of the National Medical Products Administration, the Center for Drug Evaluation (CDE) has researched and formulated the "Work Standards for Public Disclosure of Technical Review Reports of the CDE (Trial Implementation)" (see Appendix), which has been reviewed and approved by the National Medical Products Administration and is hereby released for implementation from June 1, 2021.
This is hereby announced.
Center for Drug Evaluation (CDE), National Medical Products Administration
February 23, 2021
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