ICH Project ICH S12 Guideline Briefing Session

Feb 23, 2024

Based on the review by the ICH S12 Expert Working Group, the ICH S12 Guideline reached Step 4 on March 14, 2023, and the ICH S12 Guideline "Concept of Non-clinical Biodistribution of Gene Therapy Products" was issued in Japan as a notice on October 23, 2023, and reached Step Step 5 of the guideline has been reached.
We have recently held an ICH S12 guideline briefing session for the purpose of promoting understanding of this guideline.

The program and other details of the briefing can be found on the PMDA Website.

PMDA Website

The End

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