ICH announces new topics, draft guidelines for consultation

The International Council for Harmonisation (ICH) on Wednesday announced it will develop four new guidelines addressing real-world evidence, comparative efficacy studies, rare disease drug development, and manufacturing process changes for advanced therapies. The group also endorsed several guidelines for public consultation and adopted a new concept paper on assessing mutagenic impurities in drugs.

Among the documents that were endorsed for public consultation are guidelines relating to the participation of pregnant and breastfeeding individuals in clinical trials and a long-awaited guideline on stability testing. These updates were announced following the ICH Assembly meeting in Madrid last week.

Julia Djonova, head of advanced therapy medical products at Swissmedic, said the E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials will fill a much-needed void in understanding how drugs work in this population at DIA Europe 2025. (RELATED: DIA Europe: ICH updates on pregnant, breastfeeding individuals in clinical trials, patient engagement, Regulatory Focus 19 March 2025)

ICH also touted its Q1 guideline on stability testing of drug substances, which was released for comment after reaching Step 2a/b in April just before the Madrid meeting, as well as its final E6(R3) guideline on good clinical practice, which was adopted in January. (RELATED: ICH releases overhauled stability guideline for consultation, Regulatory Focus 17 April 2025; ICH adopts E6(R3) guideline on good clinical practices, Regulatory Focus 14 January 2025).

ICH also released the multidisciplinary M4Q(R2) draft guideline concerning the quality section of the Common Technical Document (CTD) for consultation. ICH explained that this revision updates the structure and content of CTD Modules 2 and 3 to enhance support for the registration and lifecycle management of all pharmaceutical products. This includes complex modalities such as biologics, gene therapies, vaccines, and combination products.

Another achievement was the ICH release of its Step 2a/b M11 guidance, which establishes a harmonized template for clinical trial protocols known as the Clinical Electronic Structured Harmonized Protocol (CESHARP). This template was endorsed by the ICH Assembly in March 2025 and is designed to support electronic data exchange.

In other areas, the ICH Management Committee (MC) briefed the Assembly on a just-released   M7 concept paper on assessing and controlling DNA reactive or mutagenic impurities in pharmaceuticals to mitigate carcinogenic risk. The paper proposes an Addendum to the ICH M7 guideline on assessing and controlling DNA reactive or mutagenic impurities to address the safety assessment and quality risk management for N-nitrosamine impurities. The addendum on N-nitrosamines will be included as part of the ICH M7 guideline and upon finalization will be published as ICH M7(R3).

ICH has welcomed Paraguay’s National Directorate of Health Surveillance (DINAVISA), the Kuwait Ministry of Health, El Salvador’s Superintendence of Health Regulation (SRS) as observers, bringing the group’s total membership to 23 members and 41 observers.

ICH also announced that in early 2025, it will launch a MedDRA Learning Management System (LMS) offering user training in MedDRA, available in 24 languages.

The next ICH Assembly meeting will be held on 18 November 2025 in Singapore.

Announcement