The "ICH Madrid Meeting" Will Be Held

A meeting of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was held in Madrid, Spain, from May 10 to 14, 2025.In addition to the Assembly, which was attended by all ICH members and observers, a Management Committee meeting was held to discuss items to be submitted to the Assembly. During the same period, experts from various fields also gathered in Madrid, and working groups on 11 topics responsible for developing ICH guidelines held meetings.As a result of lively discussions in each working group, progress was made on drafting guidelines for the respective topics; in particular, draft technical documents for two topics reached Step 2, a major milestone within the ICH.

Group photo of the Assembly

ICH meetings are generally held in person, and 400 committee members and experts from around the world gathered in Madrid, the host city.This meeting was attended by six industry and government organizations*1 from Japan, the U.S., and the EU (the founding members), two Standing Members*2, 15 member organizations*3,

two
  • Standing
    Observers*4
    , and 23 observers.A total of 27 representatives from the JPMA—including officials from the Assembly and the Management Committee, as well as experts from working groups—traveled to Madrid, the host city.
  • *1　
    U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Japan Pharmaceutical Manufacturers Association (JPMA)
  • *2　
    • Health Canada (HC), Swissmedic (SM)
  • *3　
    Brazilian Health Regulatory Agency (ANVISA), Argentina National Superintendence of Medicines, Food and Medical Technology（ANMAT), Mexican Federal Commission for Protection against Sanitary Risks (COFEPRIS), Egyptian Drug Agency (EDA), Health Sciences Authority of Singapore (HAS), Jordan Food and Drug Administration (JFDA), Korea Food and Drug Safety Administration (MFDS), UK Medical Products Regulatory Agency (MHRA), National Medical Products Administration (NMPA) of China, Saudi Food and Drug Administration (SFDA), Taiwan Food and Drug Administration (TFDA), Turkish Agency for Medicines and Medical Devices (TITCK), Biotechnology Innovation Organization (BIO), Global Self-Care Federation (GSCF), International Generic and Biosimilar Medicines Association (IGBA)

*4　

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), World Health Organization (WHO)

The following are notable points based on the ICH Management Committee and ICH Assembly meetings held at the ICH Madrid Meeting.

1. Admission of New Observers

As ICH Observers, three organizations—Dirección Nacional de Vigilancia Sanitaria of Paraguayan (DINAVISA), Kuwait's Ministry of Health (MOH), and Superintendencia de Regulación Sanitaria of El Salvador (SRS)—submitted applications. All were approved at the Assembly and granted membership in ICH. No applications for promotion from ICH Observer to ICH Member status were received this time.

As a result, the number of members stands at 23 organizations (no change), and the number of observers at 41 organizations (an increase of 3), bringing the total number of organizations within ICH to 64 (see the reference materials at the end).

2．Trends in ICH Technical Topics

At the ICH Madrid Meeting, working groups on 11 topics convened in conjunction with the Assembly. While each group typically holds regular web conferences, they took this opportunity to engage in intensive discussions during four- or five-day in-person meetings to advance progress on guideline development. Working Groups That Held Meetings Revision of "Good Clinical Practice" General Considerations on Patient Preference Trials Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products Revision of the Specifications Guidelines Points to Note Regarding the ICH International Medical Dictionary (MedDRA)Revision of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality M7 Sub-groupAssessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Bioequivalence for Immediate-Release Solid Oral Dosage Forms
E6(R3) EWG
E22 EWG
Q3E EWG
Q6(R1) EWG
M1PtC WG
M4Q(R2) EWG
M11 EWG Clinical electronic Structured Harmonised Protocol (CeSHarP)
M13 EWG
M14 General Principles on Planning, Designing, Analysing, and Reporting of Non-interventional Studies That Utilise Real-World Data for Safety Assessment of Medicines

M15 EWG

General Principles for Model-Informed Drug Development

During this session, the draft technical documents for M4Q(R2) and E21 were approved by the Assembly, marking the achievement of Step 2—a major milestone for ICH.In addition, progress on all active topics was discussed at this Assembly, and topics that had reached major milestones since the ICH Montreal meeting in November 2024 were identified. The topics that have reached milestones are summarized below. Topics that have reached Step 4
  • E6 (R3) EWG Revision of "Good Clinical Practice": Principles and Annex 1 (January 2025)
*

Reaching Step 4 means that the draft guideline has been finally agreed upon and adopted by regulatory representatives at the ICH Assembly, and the English version of the guideline has been finalized. Moving forward, regulatory authorities in each region and country will begin the implementation process.
Topics that have reached Step 2 Stability Testing of Drug Substances and Drug Products (April 2025)
M11 EWG Clinical electronic Structured Harmonised Protocol:Technical Specification (March 2025)
M13B EWG Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver (March 2025)
Q1
M4Q(R2)
  • Revision of the “CTD—Guidance on the Preparation of Quality-Related Documents” (May 2025 ICH Assembly)
    E21
    Inclusion of pregnant and breastfeeding individuals in clinical trials (ICH Assembly, May 2025)
*

Reaching Step 2 means that a draft guideline based on technical documents has been approved by regulatory representatives at the ICH Assembly, and that the process will now move to Step 3, where regulatory authorities in each region and country will conduct public comment periods and finalize the guideline based on the results.

    • 3. Adoption of New ICH Topics

    • New topics to be addressed by ICH are selected from proposals submitted annually by ICH members. The ICH Management Committee evaluates these proposals based on their urgency, importance, and feasibility to determine whether to adopt them, and a final decision is made at the ICH Assembly. At this Assembly, the following four topics were adopted as new topics. The specific start dates for these activities will be determined at a later date.
    • Considerations Regarding the Use of Real-World Evidence (RWE) Focused on the Efficacy of Medicinal Products
A Framework for Assessing the Utility of Efficacy Comparison Studies in Biosimilar Development

Natural History Studies and Registry Data to Promote the Development of Orphan Drugs Comparability Assessment Associated with Changes to the Manufacturing Process of Advanced Therapy Medicinal Products (ATMPs) (Q5E Addendum)

Furthermore, following the advancement of M4Q(R2) to Step 2 at this Madrid meeting, activities will also commence on the topic “Structured Product Quality Submissions (SPQS),” which had previously been adopted as a new topic.
    • 4. MedDRA

    • The ICH develops and continuously maintains MedDRA.At the previous ICH meeting, the expansion of the MedDRA Steering Committee was approved, and a call for new members was issued for this meeting. Based on nominations from various organizations, an election was held at this meeting, and the following two regulatory authorities and one industry association were approved by the ICH Management Committee (for a three-year term).
China National Medical Products Administration (NMPA)

Saudi Food and Drug Authority (SFDA)

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)



Next ICH Meeting

Scheduled to be held in Singapore from November 15 to 19, 2025.

The ICH actively discloses information regarding its activities, including the outcomes of ICH meetings, and makes this information publicly available to foster a deeper understanding not only among stakeholders but also among the general public. The outcomes of the recent ICH Madrid meeting, as well as concept papers and work plans for each topic, are available on the ICH website ( https://www.ich.org/ ).

[Reference Material: List of ICH Members and Observers (as of November 2024)]
Table 1: Members (23 Organizations)

Table 2: Observers (41 organizations)

(Mariko Kato, Director, International Regulatory Coordination Department)

    Back to Announcements from the 2025 ICH Project
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