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The ICH Secretariat is pleased to announce the release of E11A Pediatric Extrapolation Training Module 1 - Case Example: Development of a hypothetical TNF-alpha inhibitor "Drug X" for the treatment of polyarticular juvenile idiopathic arthritis (pJIA).
The ICH M14 Guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines” has reached Step 4 of the ICH Process on 4 September 2025 and has now entered the implementation phase.
The ICH Q3E draft “Guideline for Extractables and Leachables” and supporting document has reached Step 2b of the ICH Process on 1 August 2025 and entered the Step 3 public consultation period.
The ICH Secretariat is pleased to announce that the updated ICH E2B(R3) Q&As, the Implementation Guide, and Appendix I (G) for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) have reached Step 4 of the ICH Process.
In follow up to the publication of the ICH E20 draft Guideline “Adaptive Designs for Clinical Trials” in June 2025, the EWG has also prepared a Step 2 informational presentation.
The ICH Secretariat is pleased to announce the release of Training Modules 1 to 7 on ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development”.
In follow up to the publication of the ICH M4Q(R2) draft revised Guideline in May 2025, the EWG has also prepared a Step 2 informational presentation.
The ICH E20 draft Guideline on “Adaptive Design for Clinical Trials” has reached Step 2b of the ICH Process on 25 June 2025 and entered the Step 3 public consultation period.