ICH Project ICH S5 and S11 Information Meeting
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 and ICH S5 (R3): "Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals" and ICH S11: "Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals 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.