ICH Project

Basic Policy

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an organization that promotes the harmonization of technical requirements for Pharmaceuticals for Human Use (TQR), which is a process by which regulatory authorities and pharmaceutical industry representatives work together to develop guidelines to ensure that effective, safe, high quality pharmaceutical products reach patients around the world in a timely and continuous manner. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (JPMA) is an international council that promotes international harmonization of technical requirements for pharmaceuticals for human use by drawing up guidelines in collaboration with JPMA regulatory authorities and representatives of the pharmaceutical industry to ensure the prompt and continuous delivery of effective, safe, and high-quality pharmaceutical products to patients worldwide.

ICH was established in 1990 by six organizations from various pharmaceutical regulatory authorities and industry associations in Japan, the U.S., and Europe. With the globalization of drug development and the pharmaceutical market, the ICH Association was established in 2015 with Swiss legal personality. Since then, ICH has continued to expand as an international regulatory harmonization platform by opening its doors to regulators from around the world and international industry associations outside of the new drug industry. The face-to-face meetings include the Assembly, which consists of all ICH members and observers, the Management Committee, which consists of some ICH members and is in charge of the actual management of ICH, and the Working Groups, where experts discuss each guideline. In March, the Management Committee and some of the Working Groups will hold an interim meeting for face-to-face discussions. Outside of the face-to-face meetings, the Management Committee and working groups hold remote meetings on a regular basis to resolve issues related to ICH management and to make progress on the guidelines.

As a founding member of the ICH Association, JPMA is a member of the Assembly and the Management Committee, which administers and manages the ICH, and participates in all working groups. He also participates as Co-Chair of the Finance Committee, which is under the Management Committee, from the Steering Committee of MedDRA, which is under the jurisdiction of ICH. Through these activities, the ICH Steering Committee contributes to the overall operation of the ICH Association, reflects the opinions of Japanese industry in international regulatory harmonization, and enhances the presence of the Japanese pharmaceutical industry in ICH activities. Although China and Brazil are increasing their presence in the ICH Management Committee, the ICH does not allow industry associations from those regions to join the ICH. The ICH project is a joint effort of the Pharmaceutical Manufacturers Association of Japan (PMAJ) and the Japanese Pharmaceutical Manufacturers Association.

Priority Issues

The ICH Project is a cross-functional organization within the JPMA that is responsible for all ICH-related activities of the JPMA. The ICH Project is a cross-functional committee within the Pharmaceutical Manufacturers' Association of Japan (JPMA), which is responsible for all ICH-related activities within the JPMA. The project collaborates with the Japanese regulatory authorities (MHLW/PMDA), domestic industry (Japan Generic Pharmaceutical Association, Japan OTC Drug Association, Japan Biosimilars Council), and other national and regional regulatory authorities and industry, and is responsible for the development and implementation of new ICH standards in quality, safety, efficacy, and multidisciplinary areas (Q, S, E). The main focus of activities will be to promote international regulatory harmonization by developing new guidelines and revising existing guidelines in the areas of quality (Q), safety (S), efficacy (E), and multidisciplinary (M).

The ICH face-to-face meetings in 2026 will be held in Rio de Janeiro (May 30-June 3) and Prague (November 14-18). Although the ICH regulations have been amended since COVID-19 to allow online participation on an exceptional basis, the ICH Project will inform committee members and experts of the ICH meetings as soon as they are scheduled, in view of the importance of the face-to-face meetings. However, in view of the importance of the face-to-face meetings, the ICH project will inform the committee members and experts as soon as the ICH meeting schedule is fixed, and will make efforts to coordinate on-site travel plans, etc. as soon as possible. In addition, the ICH Project will promote efficient ICH activities by deepening communication among experts and implementing working groups within the ICH Project and strengthening cooperation with related committees.

Priority Tasks to be addressed

In FY2026, we will particularly focus on the following three main activities

1. Proactive strategy discussion and guideline development

Work closely with the Drug Evaluation Committee and other relevant committees within the JPMA to collect and compile opinions on the guidelines under consideration in a timely and appropriate manner, with the aim of creating harmonized guidelines that will contribute to drug development in Japan. The committee will also actively work on new technical topics and strategic discussions, especially in cooperation with domestic regulatory authorities and other industry associations, to promote them.

When considering new topics for the ICH, JPMA member companies will be invited to propose useful topic ideas and provide input for the adoption of new topics. In the mid-term, in order to establish elemental technologies for drug evaluation tools that can replace animal testing in non-clinical fields where Japan has a comparative advantage, we will promote related strategic discussions in cooperation with the Drug Evaluation Committee and the R & D Committee. In the long term, the committee also aims to establish "Japan-originated ICH standards" that will contribute to Japan's growth strategy, and to link this to policy recommendations in cooperation with the Pharmaceutical Industrial Policy Committee. Furthermore, as the need to consider the "voice of the patient" in various decision-making processes comes under close scrutiny, ICH has also started to discuss topics related to "Patient-Focused Drug Development (PFDD)". In addition to contributing to the progress of E22 (General Guidelines for Patient Preference Studies), the first of these, ICH will continue to develop the Global PCPI Workshop for the provision of Patient Centric Product Information (PCPI), which was conducted in 2025.

2. Consistent implementation of the guidelines in Japan and the ICH region

As Co-Leads of the Training Subcommittee, lead the activities of the Subcommittee and promote the dissemination of new guidelines in Japan as well as ICH guidelines to other countries and regions. In order to properly implement the ICH Guidelines in Japan, dissemination activities through relevant committees are necessary, and the Sub-Committee will collaborate with the Patient Cooperation Committee as appropriate to collect opinions from various stakeholders, including patients, at an early stage. Furthermore, the activities of the ICH Management Committee, which verifies the implementation status of the ICH guidelines, will also be supported to understand the implementation status of the guidelines in each region and to promote guideline implementation. To disseminate the guidelines in the Asian region, we will cooperate with the APAC Project and the International Affairs Committee to increase contacts outside of regular ICH events, such as bilateral symposiums with the target countries. In addition, we will work to understand trends in international standards bodies regarding specifications for digitization-related guidelines and strengthen our system for responding to trends related to international harmonization of regulations.

3. Enhancement of the presence of the Japanese pharmaceutical industry in the world and Asia

While keeping in mind the linkage with the international activities of the JPMA as a whole, we will improve the presence of the Japanese pharmaceutical industry by driving international harmonization in cooperation with national and regional organizations, taking advantage of the opportunities provided by the ICH face-to-face meetings. To expand the foundation of ICH activities, we will work with related committees to recruit young people who can become candidates for the next generation of experts. In order to expand the foundation of ICH activities, we will actively promote young people who can be candidates for the next generation of experts in the activities of each committee in cooperation with related committees. In addition, proactively select expert candidates for new topics in cooperation with the Chairperson and Director of each committee.

Collaboration with other committees, etc.

Continue to strengthen the coordination function across committees by area of expertise and promote topics across committees with the cooperation of relevant committees within JPMA. Depending on the topic, we will also collaborate with related organizations and stakeholders outside the JPMA, utilizing the coordination function assigned to the ICH Project and the network within the ICH Project to take necessary actions on the following matters

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