The Assembly of the International Council for Harmonisation (ICH) met in-person on 13 & 14 May 2025, in Madrid, Spain in parallel of meetings of 11 Working Groups, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee.
The ICH continues to expand and welcomed with great pleasure DINAVISA, Paraguay; MOH, Kuwait; and SRS, El Salvador as new ICH Observers, bringing ICH to a total of 23 Members and 41 Observers.
Mr. Daisuke Koga, MHLW/PMDA, Japan, was also announced as the new ICH MC Vice-Chair, being elected to serve until the end of the next ICH meeting in November 2025 following the mid-term departure of the previous Vice-Chair, Mr. Naoyuki Yasuda, MHLW/PDMA, Japan.
New Areas of ICH Harmonisation
The Assembly adopted four new topics for harmonisation at the Madrid meeting, with the starting timeframe to be determined in a subsequent step:
- “Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines” – a new ICH Efficacy Guideline that proposes a systematic approach to using RWE in regulatory decision making;
- “Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs” – a new ICH Multidisciplinary Guideline to address factors to consider in determining the utility of comparative efficacy studies (CES) in biosimilar development programs;
- “Natural History Studies and Registry Data to Advance Rare Disease Drug Development” – a new ICH Efficacy Guideline aims to provide high-level, harmonised principles for designing and conducting natural history studies and registries in rare diseases;
- “Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process (Annex to ICH Q5E)” – A new Annex to the ICH Multidisciplinary Guideline ICH Q5E is proposed to address the unique development and regulatory challenges of ATMPs, such as gene and cell therapies.
Progress on ICH Guideline Development and Important Revisions
In addition to receiving reports on progress made at ICH Working Group meetings in Madrid, the Assembly also noted significant milestones reached by several Working Groups since the last ICH meeting, which included eagerly awaited important updates to some older ICH Guidelines, as well as new ICH Guidelines:
Final Guideline adopted at Step 4
The ICH E6(R3) Revised Guideline on “Good Clinical Practice” was adopted by the ICH Assembly (at Step 4 of the ICH process) in January 2025 prior the Madrid meeting, providing a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities. The guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. The Guideline is comprised of principles and annexes that provide specific details for different types of clinical trials.
Draft Guidelines endorsed at Step 2 a/b
- The ICH M4Q(R2) draft Guideline “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality” was endorsed by the ICH Assembly (at Step 2a/b of the ICH process) at the Madrid meeting in May 2025. This multidisciplinary revision updates the structure and content of CTD Modules 2 and 3 to better support the registration and lifecycle management of all pharmaceutical products, including complex modalities such as biologics, gene therapies, vaccines, and combination products;
- The ICH E21 draft Guideline “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” was endorsed by the ICH Assembly (at Step 2a/b of the ICH Process) at the Madrid meeting in May 2025. The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding individuals in clinical trials and to facilitate the generation of robust clinical data that support evidence-based decision making on the safe and effective use of medicinal products by these individuals and their healthcare providers;
- The ICH Q1 draft Guideline on “Stability Testing of Drug Substances and Drug Products” was endorsed by the ICH Assembly (at Step 2a/b of the ICH Process) prior to the Madrid meeting in April 2025 – for more information see the ICH Website;
- The ICH M13B draft Guideline on “Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver” was endorsed by the ICH Assembly (at Step 2a/b of the ICH process) prior to the Madrid meeting in March 2025 – for more information see the ICH Website;
- The ICH M11 “Clinical Electronic Structured Harmonised Protocol (CESHARP)” updated version of the Technical Specification document was endorsed by the ICH Assembly (at Step 2a/b of the ICH process) prior to the Madrid meeting in March 2025 – for more information see the ICH Website;
In addition, the Assembly was updated on the MC approval of the M7 Sub-group Concept Paper for the addendum on “Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”. The Addendum will include general principles and approaches for establishing acceptable intake limits for nitrosamines, as well as a framework for applying quality principles provided in the ICH M7 Guideline and its Q&A for their assessment and control.
MedDRA
During the ICH MC meeting, two additional Regulatory Members and one Standing Observer were appointed to the MedDRA Steering Committee (SC) by the ICH MC based on the SC recommendation:
- Regulatory Members: NMPA, China and SFDA, Saudi Arabia
- Standing Observer: IFPMA
The global adoption of MedDRA has reached over 9,000 subscribing organisations across 141 countries. Early 2025 saw the key launch of the MedDRA Learning Management System (LMS), offering users structured, on-demand video courses tailored to varying levels of expertise, in addition to face-to-face and Live Webinar Trainings. MedDRA is now accessible in 24 languages, with Icelandic being the latest addition in October 2024. Collaboration with international organisations is ongoing, with continued efforts to maintain and develop mappings between MedDRA and other terminologies. These activities support greater interoperability, facilitate the analysis of MedDRA-coded data, and ultimately contribute to enhancing patient safety and promoting public health.