The ICH Secretariat is pleased to announce the publication of the following training module, now available in the ICH Training Library: Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline - Module 1: Introduction and Foundational Concepts.
The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase at Step 5 of the ICH Process.
PAR update (January 2016)
In follow up to the publication of the ICH Q3E draft “Guideline for Extractables and Leachables” in August 2025, the Q3E EWG has also prepared a Step 2 informational presentation.
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).
HavrixEnd of procedure: 30/06/2025Date of publication: 25/09/2025
Pheniramine maleate, naphazoline hydrochlorideEnd of procedure: 11/08/2025Date of publication: 25/09/2025
2025, Q1-Q2 - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
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 04 September 2025 and has now entered the implementation phase at Step 5 of the ICH Process
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