ICH announces new topics, adopts harmonized template for clinical trial protocols
The International Council for Harmonisation (ICH) announced plans to develop two new guidelines on 26 November. One will focus on the use of real-world evidence (RWE) to inform regulatory decision-making, and the other will establish a framework for assessing the utility of comparative efficacy studies in biosimilar development programs. The updates were announced following the ICH Assembly held in Singapore, 18-19 November.ICH also announced the adoption of a template for clinical trial protocols and a guideline outlining definitions and standards for post-approval safety data. Additionally, the group will soon release a guideline on patient preference studies.
The ICH Management Committee approved a concept paper for a new ICH guideline E23 on Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines and a new ICH guideline M18 on a Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs.
Among the documents endorsed for public consultation is the ICH E22 guideline on General Considerations for Patient Preference Studies, which is scheduled for release in December. The draft guideline outlines general considerations about the use, design, conduct, analysis, and submission of patient preference studies aimed at informing drug development.
The group also announced the release of the ICH Q3E draft Guideline for Extractables and Leachables, which is currently undergoing a public consultation period. This draft guideline outlines a framework for assessing and controlling leachable impurities in drug products (RELATED: ICH releases Q3E guideline on controlling extractables and leachables in drugs, Regulatory Focus, 7 August 2025).
ICH also announced that its E20 draft guideline on Adaptive Design for Clinical Trials is now in the public consultation phase. The draft provides guidance on confirmatory trials that use an adaptive design to evaluate treatments for a specific medical condition within the framework of its overall development program (RELATED: ICH releases E20 guideline to assist sponsors in designing adaptive clinical trials, Regulatory Focus, 27 June 2025).
Among the documents that were adopted is the release of its M11 guidance, which establishes a harmonized template for clinical trial protocols known as the Clinical Electronic Structured Harmonized Protocol (CeSHarP). The template and technical specification were endorsed by the ICH Assembly in March 2025 and is designed to facilitate electronic data exchange.
The ICH E2D(R1) guideline on Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports was adopted in September 2025 and is currently being implemented by regulators. It provides harmonized recommendations for post-market data and individual case safety reports (ICSRs) across ICH regions. It was released for public consultation in February 2024 (RELATED: ICH consults on revised post-approval safety guideline that accounts for digital platforms, Regulatory Focus, 16 February 2024).
The ICH M14 guideline, General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies that Utilise Real-World Data for Safety Assessment of Medicines, has been adopted and is now being implemented. This guideline aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies that use real-world data (RWD) to evaluate the safety of marketed drugs and vaccines. Additionally, it provides high-level best practices for conducting these studies (RELATED: ICH adopts M14 guideline on observational studies, Regulatory Focus, 15 September 2025).
ICH has announced the addition of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) and South Africa’s Health Products Regulatory Authority (SAHPRA) as new members. The group also announced that the Dominican Republic’s DIGEMAPS and the Philippines FDA have joined as observers, bringing the group’s total membership to 25 members and 41 observers.
The next ICH Assembly meeting will be held on 2 June 2026 in Rio de Janeiro.
ICH announcement
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