ICH Project
Interview with Chairperson Yokota

ICH was established in 1990 by six organizations of regulatory authorities and industry associations in Japan, the U.S., and Europe, As of July 2025, the Association has 23 members and 41 observers, making it a large organization with a total of 64 organizations.

The ICH project of the Pharmaceutical Manufacturers Association of Japan (PMAJ) participates in the ICH Association on behalf of the PMAJ and is responsible for the formulation of guidelines specific to pharmaceutical regulations. In doing so, the project contributes to strengthening drug discovery capabilities by reflecting Japan's strengths in international standards and by incorporating international standards into Japanese industry. The ICH project is also responsible for the exchange of opinions and coordination on crosscutting technical issues with the various committees of the Pharmaceutical Manufacturers' Association of Japan (PMAJ), and serves as a hub for collaboration within the PMAJ.

In order to carry on and develop the legacy of the founding of ICH, the ICH Project recognizes that one of the key issues is "securing human resources for ICH activities. Many veteran experts with a proven track record are approaching retirement, and a smooth generational change is an urgent issue. In light of this situation, in April of this year, we asked member companies of the Pharmaceutical Manufacturers Association of Japan (PMAJ) to cooperate in industry activities, including the dispatch of personnel, in order to broaden the pool of potential ICH experts.

Specifically, we are encouraging member companies to view the ICH project as a "training ground" for human resources who will be responsible for shaping international rules, and to invite prospective experts in their 30s and 40s to participate in the project. We will collaborate with other committees in order to systematically promote the development of experts and build a mechanism for them to play an active role in ICH. In addition, we also told them that we see ICH activities as an opportunity to develop global human resources and hope that they will proactively incorporate ICH activities as a career path in their human resource development plans.

However, since it takes time to develop ICH experts, we are considering selecting people who are active as expatriates to participate in ICH activities from overseas as an immediate measure. Japanese experts who are well versed in global development are a valuable asset to the entire pharmaceutical industry, and we will proactively create a stage for them to play an active role in cooperation with each committee.

We also place importance on the perspective of "Japan in Asia" when engaging in ICH activities, as the Pharmaceutical Manufacturers Association of Japan (PMAJ) is the only pharmaceutical organization that represents the Asian region among the industries participating in ICH. As the U.S. FDA under the second Trump administration is reducing resources for international cooperation, Japan, as one of the founding countries of ICH, would like to play a central role and exert its presence in cooperation with members in the Asian region. We will contribute not only to the development of the Japanese pharmaceutical industry, but also to the healthy growth of the Asian pharmaceutical industry.

At the ICH Madrid meeting in May 2025, we discussed sustainable ICH management and adopted four new topics. Four new topics were adopted at the ICH Madrid meeting in May 2025.

Considerations for RWE utilization with a focus on drug efficacy" is a new topic that the Pharmaceutical Manufacturers Association of Japan (PMAJ) has strongly supported since the discussion stage. We strongly hope that the development of these guidelines will promote the optimal use of RWE, especially in areas where it has been difficult to evaluate efficacy in the past, such as the pediatric field. Two experts from the Pharmaceutical Manufacturers Association of Japan (PMAJ) have been dispatched to the Expert Working Group.

Next is "Framework for Determining the Usefulness of Comparative Efficacy Studies in BS Development," which is the first time that the ICH has adopted a new topic specific to BS. The objective is to establish a general framework to streamline biosimilar development by applying Q5E on comparability assessment of biopharmaceuticals. Since the similarity evaluation of biosimilars and the comparability evaluation of biotech new drugs are two sides of the same coin, two experts from the Pharmaceutical Manufacturers Association of Japan (PMAJ) will be dispatched to the meeting to ensure that the discussions are fully prepared.

In addition, "Natural History Research and Registry Data to Facilitate Rare Disease Drug Development" is expected to serve as a guideline that provides basic principles for maximizing the use of natural history research and registry data in drug development in order to facilitate the development of drugs for rare diseases for which the number of patients is small and clinical development is difficult. In Japan, drug lag and drug loss, particularly for drugs for rare diseases, is an issue, and we hope that the guidelines will help improve patient access to drugs for rare diseases that are particularly difficult to develop clinically, such as ultraorphans, for which the number of patients is extremely limited worldwide.

Finally, the "Comparability Assessment of Advanced Medical Products (ATMPs) for Manufacturing Process Changes (Q3E Addendum)" is an addendum specifically for comparability assessment of ATMPs, as the number of cases that cannot be addressed by the ICH guidelines is increasing due to the diversification of modalities and the existing guidelines are The addendum will complement the existing guidelines and provide recommendations for cases where alternative approaches are needed. We expect that this will enable flexible comparability assessment of complex cell-derived ATMPs, which are difficult to characterize, by using a risk-based approach.