ICH Project ICH S12 Guideline Workshops
Feb. 23, 2024
Based on the study by the ICH S12 Expert Working Group, the ICH S12 Guideline reached Step 4 on March 14, 2023, and in Japan, the ICH S12 Guideline "Concept of Non-clinical Biodistribution of Gene Therapy Products" was issued as a notification on October 23, 2023. In Japan, the ICH S12 Guideline, "Approach to Nonclinical Biodistribution of Gene Therapy Products," was issued as a notice on October 23, 2023, reaching Step 5.
In order to promote understanding of this guideline, ICH S12 Guideline Workshops were held this time.
The program and details of the briefing can be found on the PMDA Website.