ICH Madrid Meeting" was held in Madrid, Spain.

The meeting of the International Conference on Harmonization of Pharmaceutical Regulations (ICH) was held in Madrid, Spain, from May 10-14, 2025. The meeting included a General Assembly attended by all ICH members and observers, as well as a Management Committee meeting to discuss the agenda for the General 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 in the development of guidelines for each topic, with two draft technical documents in particular reaching Step 2, a major milestone in the ICH process.

Overall picture of the General Meeting

The ICH meeting was held in Madrid, where 400 committee members and experts gathered from all over the world. The meeting was attended by 400 committee members and experts from around the world.¹ 2 permanent member organizations² 15 member organizations³ 3, 2 permanent observer organizations⁴ and 23 observer organizations. Twenty-seven members of the Pharmaceutical Manufacturers Association of Japan (PMAJ), including those from the General Assembly, the Management Committee, and experts from the Working Groups, traveled to Madrid, the venue of the conference.

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 National Health Supervisory Agency (ANVISA), Argentine National Agency for Medicines, Food and Medical Technology (ANMAT), Mexican Federal Commission for Sanitary Risk Control (COFEPRIS), Egyptian Authority (EDA), Health Sciences Authority of Singapore (HAS), Jordan Food and Drug Administration (JFDA), Korea Food and Drug Safety Agency (MFDS), United Kingdom (MFDS), UK Medicines and Healthcare products Regulatory Agency (MHRA), China National Medicines Regulatory Administration (NMPA), Saudi Food and Drug Administration (SFDA), Taiwan Food and Drug Administration (TFDA), Turkey's Pharmaceuticals and Medical Devices Agency (TITCK), Biotechnology Innovation Institute (BIO), Global Self Care Federation (GSCF) Federation (GSCF), International Generic and Biosimilar Pharmaceuticals 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 General Assembly at the ICH Madrid Meeting.

1. membership of new observers

Three new applications for ICH observer membership were received from the National Sanitary Surveillance Directorate of the Paraguayan Ministry of Public Health and Social Welfare (DINAVISA), the Kuwaiti Ministry of Health (MOH), and the Sanitary Regulatory and Supervisory Agency of El Salvador (SRS), and all were approved by the General Assembly for membership in the ICH. There were no applications from ICH observers to be promoted to ICH members.

As a result, there were 23 member organizations (no increase or decrease) and 41 observer organizations (3 increase), bringing the overall ICH organizational structure to 64 organizations (see reference material at the end of this report).

2. Trends in ICH Technical Topics

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

Working Groups with Meetings

E6(R3) EWG	Revision of "Standards for the Conduct of Clinical Trials of Pharmaceuticals
E22 EWG	General Considerations for Patient Preference Studies
Q3E EWG	Guidelines for Extractables and Eluates of Pharmaceuticals
Q6(R1) EWG	Revision of "Establishment of Specifications and Test Methods for Pharmaceutical Products
M1PtC WG	Notes on ICH International Drug Terminology (MedDRA)
M4Q(R2) EWG	Revision of "Common Technical Documents - Guidelines for the Preparation of Quality Documents
M7 Sub-group	Evaluation and Control of DNA Reactive (Mutagenic) Impurities in Drugs to Reduce Potential Carcinogenic Risk -Nitrosamine Impurity Management
M11 EWG	Electronically Structured and Harmonized Clinical Trial Protocols
M13 EWG	Bioequivalence Studies of Immediate Release Oral Solid Dosage Forms
M14 EWG	General Principles for the Planning, Design and Analysis of Pharmacoepidemiological Studies Using Real World Data in the Safety Assessment of Pharmaceuticals
M15 EWG	General Principles for Model-Informed Drug Development

During this meeting, the draft technical documents for M4Q(R2) and E21 were approved by the General Assembly, reaching Step 2, an important milestone for ICH. The Plenary also discussed the progress of all active topics and identified topics that have reached major milestones since the November 2024 ICH Montreal meeting. The following is a summary of topics that have reached milestones.

Topics reached in Step 4

E6(R3)

Revision of the "Standard for the Conduct of Clinical Trials for Pharmaceuticals": Principles and Annex 1 (January 2025)

Next ICH meeting

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

Topics reached in Step 2

M11	Electronically structured and harmonized clinical trial protocols: technical specifications (March 2025)
M13B	Bioequivalence studies of immediate-release oral solid dosage forms: additional content biowaiver (Mar 2025)
Q1	Stability studies of drug substance and formulation (April 2025)
M4Q(R2)	Revision of "CTD - Guideline for Quality Documentation" (ICH Assembly, May 2025)
E21	Inclusion of pregnant and lactating women in clinical trials (ICH General Assembly, May 2025)

Next ICH meeting

Reaching Step 2 means that the draft guideline based on the technical document has been approved by the regulatory delegates at the ICH Assembly and will now move to Step 3 where the guideline will be finalized based on the results of the public comment by the regional and national regulatory authorities.

3. Adoption of new ICH topics

The ICH Management Committee reviews the urgency, importance, feasibility, etc. of new topics proposed by ICH members each year and decides on the adoption or rejection of new topics at the ICH General Assembly. The following four topics were adopted as new topics at the ICH General Assembly this year. 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 of Advanced Medical Therapeutics (ATMP) Manufacturing Process Changes (Q5E Addendum)

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

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. Based on the candidacies of the organizations, elections were held at this meeting and the following two regulatory authorities and one trade association were approved by the ICH Trustees (for three-year terms).

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

Next ICH Meeting

The meeting will be held in Singapore from November 15-19, 2025.

ICH proactively discloses information on its activities, including the outcomes of ICH meetings, for the better understanding of the public as well as interested parties. The outcomes of the ICH Madrid meeting, concept papers on each topic, work plans, etc. are available on the ICH website (( Available
from https://www.ich.org/)

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[Reference: 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 ICH Project

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