The 15th Annual Conference of the Regulatory Science Society of Japan to be held Quality Assurance and Regulatory Science

Chairperson: Yuji Kashiwatani, Chairman, Pharmaceutical Affairs Committee, Pharmaceutical Manufacturers Association of Japan

Mr. Yasuhiro Araki, Director, Office of Clinical Trial Promotion, Research and Development Policy Division, Medical Affairs Bureau, Ministry of Health, Labour and Welfare, started the session with a lecture titled "Challenges in Composing Examination Reports in the AI Era". In his speech, Mr. Araki touched on the increasing number of applications in recent years and the challenges faced by the Pharmaceuticals and Medical Devices Agency (PMDA), where applications for approval are concentrated in specific disease areas and periods, and explained that studies are underway to improve the efficiency of review report preparation by utilizing AI. In the study, three types of generation AIs were used to evaluate the quality of generation, and the differences in performance between them were confirmed. In terms of future prospects, he mentioned the need to develop an environment for use in CTD Module 5, which is a non-public document, to formulate operational rules and secure budgets for AI utilization, with a view to supporting the creation of clinical clauses, which are in high demand.

Next, Mr. Koichi Masuyama, Faculty of Pharmaceutical Sciences, Tokyo University of Pharmacy and Life Sciences, gave a lecture titled "Education at our university regarding review reports and future ideals". In his lecture, he introduced the effective use of review reports in lectures to pharmacy students to deepen their understanding of pharmaceutical products. He then proposed that since the current Examination Report sometimes makes the issues and conclusions unclear, writing the conclusion of the "Examination Report (2)" at the beginning of the report would clarify the contents and make the Examination Report more easily understood by medical professionals. Reference was also made to the English version of the Examination Report, and it was suggested that promptly translating only the "Examination Report (2)" into English would be effective in promptly disseminating the key points of the Japanese examination overseas.

Chairperson: Tsuyoshi Yamamoto, Director, Monitoring and Guidance Office, Monitoring and Guidance and Narcotics Control Division, Ministry of Health, Labour and Welfare
　　　Chairman: Yuji Kashiwatani, Pharmaceutical Affairs Committee, Pharmaceutical Manufacturers Association of Japan

In Symposium 7, speakers from industry associations, PMDA, regional government agencies, and academia gave presentations on the GMP investigation system that goes beyond the recent revision of the Pharmaceutical Affairs Law, followed by a panel discussion.

First, Mr. Makoto Ono, Chairman of the Quality Committee of the Federation of Pharmaceutical Manufacturers' Associations of Japan (JFPMA), gave a presentation on the results of a survey conducted by JFPMA on manufacturers titled "The Use of Category Conformity Surveys in GMP Surveys". He indicated that many manufacturers do not use this system under the current system, and expressed his hope that the issues considered by each company will be resolved in the implementation of the revised Pharmaceutical Affairs Law.

Mr. Zenichi Yamamoto, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented the "Questionnaire 2025 on the Review Status of New Drugs and New Regenerative Medicine Products," which was designed to evaluate the current status of the review process for items approved in 2024 and to propose measures to increase efficiency and improve it, targeting 66 member companies of the PMAJ Pharmaceutical Affairs Committee. The results of the survey conducted in January 2025 were presented.

The median time from application to approval for regular review items was 11.0 months, and 8.4 months for priority review items. 44% of the items had an interview with the review team other than the initial interview, which was similar to the 46% in the previous survey. More than 90% of the items were submitted electronically, up from 81% in the previous survey. As for the level of satisfaction with the review, many positive comments such as "good communication" and "courteous and flexible response" were found, while "efficiency improvement" such as abolishing the delivery of technical consultation materials and eCTD lifecycle updates and reviewing CTD amendment requests for products reported by the subcommittees, and "earlier stage" such as bringing forward the timing of post-marketing surveillance discussions He also expressed his hope for further improvement through "discussions and actions at an earlier stage" such as bringing forward the timing of discussions on post-marketing surveillance.

Kyohei Shintaku, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented the results of a survey on the status of development projects as of 2025 among the member companies of the PMAJ Pharmaceutical Affairs Committee under the theme of "Current Status of Development Projects at Member Companies of the PMAJ.

The number of projects increased from the previous year, and the percentage of international clinical trials was high at over 80%. Skipping of Japanese P1 trials is on the rise due to notification, and safety assurance measures are also diversifying. In rare disease and pediatric development, domestic clinical trials were still emphasized, and the trend toward requiring submission of Japanese data at the time of application for approval continued. The new notice issued after the Study Group on the Regulation of Pharmaceutical Affairs to Enhance Drug Discovery and Ensure Stable Supply (commonly referred to as the "Study Group on the Regulation of Pharmaceutical Affairs") is of limited use, and future operation of the system and company responses are expected.

Mr. Kenshin Nakanishi, a member of the Pharmaceutical Affairs System Subcommittee of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented the results of a comparative study of European and U.S. change guidelines/guidance with a view to the February 10 notification revision (Japanese version of change procedure guidelines) under the theme of "Comparative study of European and U.S. change guidelines/guidance with a view to the February 10 notification revision (Japanese version of change procedure guidelines)". The presentation included the results of the comparative study of the European and U.S. change guidelines and questionnaire opinions on the Japanese version of the Guidelines.

It became clear that there are differences in classification and focus. In Europe, conditions and change categories for change contents are described, while in the U.S., the concept of change categories and examples for each category are presented. For the Japanese version of the guideline, it was considered important to present a concept that shows the basic idea of change procedures and criteria for judgment, and to design a system that allows flexible operation based on the background of the change, risks, and product characteristics, rather than mechanically referring to the change cases shown in the guideline for judgment.

The results of this comparative study of European and U.S. change guidelines are expected to serve as a cornerstone in the study of change procedure guidelines based on the international consistency of Japan's pharmaceutical affairs system and contribute to the stable supply of high-quality pharmaceutical products in line with global standards.

Chika Takamura, a member of the Pharmaceutical Affairs Subcommittee of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and other members of the Pharmaceutical Affairs Subcommittee on the theme of "Issues from the standpoint of manufacturers and distributors regarding the Master File (MF) system," conducted a survey of member companies of the Pharmaceutical Affairs Subcommittee to clarify issues related to the MF system from the viewpoint of manufacturers and distributors, as it has been about 20 years since the introduction of the system. The survey was conducted on member companies of the Pharmaceutical Affairs System Subcommittee to clarify the challenges of the Master File (MF) system from the viewpoint of manufacturers and distributors.

The survey revealed that many manufacturers and distributors felt that the MF system was complicated to operate, especially that it was difficult to see the progress of the review and that they were held accountable while the details of the review were not disclosed. Inadequate change management and information communication were also pointed out, highlighting the reality of the impact on actual operations.

Many specific requests for improvement of the MF system were raised, such as simplification of descriptions, introduction of independent review by MF registrants, clarification of change communication, simplification of submitted materials, and coordination with overseas systems. In the free-response section, opinions were also expressed regarding the need for flexibility in practice and information disclosure.

The survey once again demonstrated the need for discussion on the revision of the MF system.

Ms. Sayaka Ichihara, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented the results of a questionnaire survey conducted to ascertain the actual status of application lag for new drugs approved in FY2022-2023, under the theme of "Questionnaire on the Survey on the Current Status of Application Lag in Japan.

For drugs containing new active ingredients, "simultaneous application" accounted for the highest percentage at 51.8%, with participation in global joint clinical trials and the establishment of internal systems to enable simultaneous application cited as the main reasons. For pediatric drugs, "simultaneous application" and "prior application in Japan" were also on the increase, suggesting that the improvement of the Japanese system based on the discussion at the study group has contributed to the increase. Japan's participation in the Phase III global clinical trials is effective in shortening the application lag, and future strengthening of international collaboration is expected.

Takuko Okamoto, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented the results of a questionnaire survey conducted from October 2023 to September 2024 (October 2022 to September 2024 for pioneering comprehensive evaluation consultation and advance evaluation consultation) on the theme "Questionnaire regarding the current status of face-to-face advice provided by the Pharmaceuticals and Medical Devices Agency and companies' perceptions of the current status of such advice". The results of the questionnaire survey on face-to-face advice were presented.

The questionnaire survey showed that 350 face-to-face advising sessions were conducted during the survey period, and the level of satisfaction on the part of companies remained high. On the other hand, about 30% of companies pointed out problems, and many asked for flexible views and alternative proposals. Preliminary interviews were considered effective in enhancing consultation materials and mutual understanding, and careful communication with the PMDA was considered important. It was also suggested that clear presentation of benefits, such as early approval, is required for the use of pre-evaluation consultation.

Under the theme of "The Current Status and Issues of Education Methods for Regulatory Affairs Personnel," Yukihiro Tarui, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Affairs Association of Japan, and others presented the results of a questionnaire survey of member companies of the Regulatory Affairs Committee on the current status and issues of education and training methods for regulatory affairs personnel, as well as the results of discussions based on the results of the questionnaire survey. The results of the survey and discussions based on the results were also presented.

The results of the questionnaire survey on the abilities required of regulatory affairs personnel and the methods used to educate them, the challenges they face in education, and the use of industry activities were discussed. The survey also revealed that practical education centered on on-the-job training is considered important, and that the lack of time and personnel to provide education is an issue. In response to these issues, we proposed the need to create a mechanism for information sharing, improve operational efficiency, and actively utilize industry activities. In particular, we suggested that it would be useful to focus on the development of young employees and to create opportunities for the industry to learn and improve their skills, as sharing knowledge and experience throughout the industry is considered important. The committee also expressed the view that it would be useful to create opportunities for the industry to acquire and improve competencies.

Makoto Fujikawa, a member of the Pharmaceutical Affairs Subcommittee of the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others presented a questionnaire report based on the review agreed to by the Pharmaceuticals and Medical Devices Subcommittee of the GMP Conformity Assessment System (focusing on the Standard Verification Certificate) - Consideration from the perspective of manufacturers and distributors. The results of the questionnaire survey conducted from March to May 2025 among member companies of the Pharmaceutical Affairs Subcommittee were presented.

The results of the survey showed that the GMP survey system agreed to by the Health Sciences Council (Pharmaceuticals and Medical Devices System Subcommittee) is expected to result in a slight increase in the number of manufacturers and distributors obtaining a Standard Verification Certificate for their manufacturing facilities, and that it is necessary to operate a system that provides benefits to both manufacturers and distributors. The results of the survey also revealed the need to promote the acquisition of the Certificate of Confirmation of Standards or to improve it. In addition, the committee also indicated that the scope of application of the Standard Verification Certificate (pre-approval survey, etc.) needs to be expanded in order to streamline and improve the efficiency of GMP surveys, and that, from a long-term perspective, it is necessary to revise the law to "make all GMP surveys, including pre-approval surveys, risk-based surveys at each manufacturing site (in principle, on-site surveys)" which will lead to strengthening GMP management at manufacturing sites and resolving issues related to stable supply. The panelists indicated that it is necessary to continue discussing the revision of the law and the design of the system to "all GMP surveys, including pre-approval surveys, on a risk-based, site-by-site basis (in principle, on-site surveys)," which will lead to strengthening GMP management at manufacturing sites and solving issues of stable supply.