ICH Project ICH S5/S11 Briefing Session
September 02, 2021
Based on the discussions in ICH S5 (R3) and S11 Expert Working Group (EWG), ICH S5 (R3) and ICH S11 Guidelines have reached Step 5, ICH S5 (R3): "Guidelines for the Evaluation of Reproductive and Developmental Toxicity of Pharmaceutical Products", ICH S11: " ICH S11: "Guidelines for non-clinical safety studies for pediatric drug development" was issued as a notice.
Guideline Workshops were held to promote understanding of these guidelines.
The program and other details of the briefing can be found on the PMDA Website.