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CDE publicly solicits opinions on M7 (R2) related ICH guidelines

 Last Update: 2021-12-24
 Source: Internet
 Author: User

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On December 21, CDE issued an announcement stating that the ICH guideline "M7 (R2): Assessment and Control of Active DNA (Mutogenic) Impurities in Drugs to Limit Potential Carcinogenic Risks" is now in the third stage for comments

See the attachment for the original text and Chinese translation of M7 (R2).

If you have any comments from all walks of life, please send feedback to our center via e-mail before February 15, 2022

Contact: Ma Lei, Zhou Zhixing

Email: mal@cde.

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