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Notice on Public Solicitation of ICH Guiding Principles "S12: Research on Biodistribution of Gene Therapy Products"

 Last Update: 2021-08-08
 Source: Internet
 Author: User

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The ICH guiding principle "S12: Research on the Biodistribution of Gene Therapy Products" is now in the third stage for comments
.

In accordance with the requirements of the relevant ICH regulations, the members of the ICH regulatory body need to collect opinions from the region on the draft guidelines for stage 2b and feed back to ICH

See the attachment for the original text and translation of the S12 draft.

If you have any comments from all walks of life, please give feedback to our center via email before October 15, 2021

Contact: Ye Xuan

Email: yex@cde.

annex:

ICH work office

July 13, 2021

Attachment 1: [English] ICH_S12_Step2_DraftGuideline.

[English] ICH_S12_Step2_DraftGuideline.

[Chinese] Non-clinical biodistribution considerations of S12 gene therapy products (Step3).
pdf

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