ICH Project ICH S12 Guideline Workshops
February 23, 2024
Based on the discussions in the ICH S12 Expert Working Group, the ICH S12 Guideline reached Step 4 on March 14, 2023, and the ICH S12 Guideline "Nonclinical Biodistribution Considerations for Gene Therapy Products" was issued in Japan as a notice on October 23, 2023, reaching Step Step 5 of the guideline has been reached.
We have recently held ICH S12 Guideline Workshops for the purpose of promoting understanding of this guideline.
The program and other details of the briefing can be found on the PMDA Website.