ICH Madrid Meeting" was held.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) held its meeting in Madrid, Spain, from May 10-14, 2025. The meeting included a Assembly attended by all ICH members and observers, as well as a Management Committee meeting to discuss the agenda for the Assembly. During the same period, experts from various fields also gathered in Madrid, where the 11 topic working groups responsible for developing the ICH Guidelines held meetings. As a result of active discussions in the working groups, progress was made on the development of guidelines for each topic, with two draft technical documents in particular reaching Step 2, a major milestone in the ICH process.

General view of the Assembly

The ICH meeting was held in principle as a face-to-face meeting, and 400 committee members and experts from all over the world gathered in Madrid. The meeting was attended by 6 ^{Industry-Government*1} organizations, 2 Standing ^Members*2, 15 ^Members*3, 2 Standing ^Observers*4, and 23 Observers from Japan, the U.S., and the EU, all of which are founding members. Twenty-seven JPMA members, including those from the Assembly and Management Committee and experts from the Working Groups, traveled to Madrid, where the meeting was held.

1

U.S. Food and Drug Administration (FDA), European Commission/European Medicines Agency (EC/EMA), Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Manufacturers 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 and Associations (IFPMA), World Health Organization (WHO)

The following are special notes based on the ICH Management Committee and ICH Assembly at the ICH Madrid Meeting. 1.

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, there were 23 members (no increase or decrease) and 41 observers (3 increase), bringing the total number of ICH organizations to 64 (see the reference material at the end of this report).

2．Trends in ICH Technical Topics

At the ICH Madrid meeting, 11 Topic Working Groups met in conjunction with the Assembly. The groups, which normally hold regular web meetings, took the opportunity to hold intensive discussions during four or five days of face-to-face meetings to make progress in the development of the guidelines.

Working groups that met

E6(R3) EWG	Revision of "Good Clinical Practice"
E22 EWG	General Considerations for Patient Preference Trials
Q3E EWG	Evaluation and Control of Extractables and Leachables of Pharmaceutical and Biological Products
Q6(R1) EWG	Revision of the Specifications Guidelines
M1PtC WG	Notes on ICH International Drug Terminology (MedDRA)
M4Q(R2) EWG	Revision of the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality
M7 Sub-group	Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
M11 EWG	Clinical electronic Structured Harmonised Protocol (CeSHarP)
M13 EWG	Bioequivalence for Immediate-Release Solid Oral Dosage Forms
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 Assembly, the draft technical documents for M4Q(R2) and E21 were approved by the Assembly, reaching the important ICH milestone of Step 2. The Assembly also discussed the progress of all active topics and identified topics that have reached major milestones since the November 2024 ICH Montreal meeting. Below is a summary of topics that have reached milestones.

Topics that have reached Step 4

E6 (R3) EWG

Revision of "Good Clinical Practice": Principles and Annex 1 (January 2025)

Step 4 has been reached.

Reaching Step 4 means that the draft guidelines have been finally agreed upon and adopted by the regulatory representatives at the ICH Assembly, and the English version of the guidelines has been finalized. The implementation process will now be initiated by the regulatory authorities in each region and country.

Topics that have reached Step 2

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	Stability Testing of Drug Substances and Drug Products (April 2025)
M4Q(R2)	Revision of "CTD - Guideline for Quality Documentation" (ICH Assembly, May 2025)
E21	Inclusion of pregnant and breastfeeding individuals in clinical trials (ICH Assembly, May 2025)

M4Q(R2)

Reaching Step 2 means that the draft guideline based on the technical document has been approved by the regulatory representatives at the ICH Assembly and will move to Step 3 where the guideline will be finalized based on the results of public comment by the regulatory authorities in each region and country.

3. adoption of new ICH topics

Each year, the ICH Management Committee selects new topics from among the proposals submitted by ICH members, examines their urgency, importance, feasibility, etc., and decides on their adoption at the ICH Assembly. The following four new topics were adopted at this Assembly. The specific timing of the start of activities will be discussed in the future.

Considerations for the use of Real World Evidence (RWE) focusing on the efficacy of pharmaceutical products
Framework for determining the usefulness of comparative efficacy studies in biosimilar development
Natural History Studies and Registry Data to Facilitate Rare Disease Drug Development
Comparability Assessment for Advanced Medical Products (ATMPs) with Manufacturing Process Changes (Q5E Addendum)

With M4Q(R2) reaching Step 2 at the Madrid meeting, the topic "Structured Product Quality Submissions (SPQS)," which was previously adopted as a new topic, will now also be activated. SPQS", which was adopted as a new topic in the past, will also be activated in the future.

4. MedDRA

ICH has developed and continues to maintain MedDRA. At the last ICH meeting, it was approved to expand the membership of the MedDRA Steering Committee and a call was made for new members. After elections were held at this meeting based on candidacies from various organizations, the following two regulatory authorities and one trade association were approved by the ICH Management Committee (three-year terms).

National Medicines Regulatory Administration of China (NMPA)
Saudi Food and Drug Administration (SFDA)
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Next ICH Meeting

The next ICH meeting will be held in Singapore from November 15 to 19, 2025.

ICH actively discloses information on ICH activities, including the outcomes of ICH meetings, for the better understanding of not only the stakeholders but also the general public. The outcomes of the ICH Madrid meeting, concept papers on each topic, and the work plan are available on the ICH website ( https://www.ich.org/ ).