ICH Project Briefing on ICH S5 and S11
Sep 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 and ICH S5 (R3): "Guidelines for the Evaluation of Reproductive and Developmental Toxicity of Pharmaceutical Products" and ICH S11: "Guidelines for Nonclinical Safety Studies for Pediatric Drug Development ICH S11: "Guidelines for non-clinical safety studies for pediatric drug development" was issued as a notice.
The purpose of the meeting was to promote understanding of these guidelines.
The program and other details of the briefing can be found on the PMDA Website.
The End