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Notice on Public Solicitation of ICH E14 and Q&A and Q3C (R8) Guiding Principles Implementation Suggestions

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

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In order to do a good job in the implementation of the ICH guidelines, our center has drafted the ICH "E14 and Q&A: Non-antiarrhythmic drugs-induced QT/QTc interval prolongation and potential arrhythmogenic effects of clinical evaluation and Q&A documents" and "Q3C (R8) ): Impurities: Residual Solvents" Guiding Principles Transformation and Implementation Suggestions are now open for comments
.

Please send relevant opinions to our center by e-mail before December 2, 2021: gkzhqyj@cde.
org.
cn

E14 and Q&A and Q3C (R8) guidelines can be found on the ICH website
.

(Https://

Attachment: ICH E14 and Q&A and Q3C (R8) Guiding Principles Transformation and Implementation Suggestions

Drug Evaluation Center of the State Drug Administration

November 2 2021

Relevant attachments: 1ICH E14 and Q&A and Q3C (R8) Guiding Principles Implementation Suggestions.

1ICH E14 and Q&A and Q3C (R8) guidelines implementation recommendations.
docx

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