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CDE publicly solicits ICH E14, Q&A and Q3C (R8) guidelines for implementation suggestions

 Last Update: 2021-11-14
 Source: Internet
 Author: User

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On November 2, the CDE official website issued an announcement stating that in order to do a good job in the implementation of the ICH guidelines, the center drafted the ICH "E14 and Questions and Answers: Non-antiarrhythmic drugs cause QT/QTc interval prolongation and potential arrhythmic effects.
Clinical evaluation and question and answer documents" and "Q3C (R8): Impurities: Residual Solvents" guideline transformation and implementation suggestions are now open for comments
.
Please send relevant opinions via email to: gkzhqyj@cde.
org.
cn E14 and Q&A and Q3C (R8) guidelines on the ICH website before December 2, 2021
.
(Https://
.
Attachment: ICH E14, Q&A and Q3C (R8) Guiding Principles Transformation and Implementation Suggestions

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