The 14th Annual Conference of the Regulatory Science Society of Japan Regulatory Science to Open the Future of Medicine

The 14th Annual Meeting of the Regulatory Science Society of Japan was held at Hitotsubashi Auditorium, Hitotsubashi University (Chiyoda-ku, Tokyo) on September 13-14, 2024, under the theme of "Regulatory Science to Open the Future of Medicine.

Introduction

The Regulatory Science Society of Japan (RS Society) was established in August 2010 with the founding principle of bringing together people in the medical field, universities, research institutions, industry, and regulatory authorities on an equal footing to openly discuss research results and ideas related to regulatory science for pharmaceuticals and medical devices, and to promote the academic progress and dissemination of such science. The society was established in August 2010. The Pharmaceutical Manufacturers Association of Japan (PMAJ) also actively participates in the annual symposium by planning and proposing symposiums, supporting the operation of the symposiums, and making poster presentations in order to discuss systems related to pharmaceutical affairs and their operation with academia and the regulatory authorities such as the Ministry of Health, Labor and Welfare (MHLW) and the Pharmaceutical Affairs Agency. We actively participate in these symposiums by planning and proposing symposiums, assisting in their operation, and presenting posters.

In 2024, the symposium was held over two days from September 13-14, with active discussions in each section under the theme of "Regulatory Science to Open the Future of Medicine.

The conference consisted of a plenary lecture, three special lectures, one symposium planned by the President, 12 symposia, and general presentations (15 oral presentations and 29 posters).

Symposium 4

Future issues to be addressed in response to the discussions at the "Study Group on Regulatory Framework for Strengthening Drug Discovery and Ensuring Stable Supply of Drugs

Next, Mr. Shinichiro Takeuchi of the Regulatory Affairs and Development Strategy Department of Aculis Pharma, Inc. gave his opinion on the study group from the standpoint of a start-up company introducing an overseas product in Japan as "Implementation and Issues Following the Study Group on Regulatory Affairs: Issues and Expectations for Measures (Venture Perspective)". The opinions of the panel were expressed from the standpoint of a start-up company introducing an overseas product in Japan. He argued that when a start-up company introduces an overseas product, it is necessary to explain to investors the probability of its sales forecast, development strategy and costs, and post-marketing activities, etc. Therefore, it is important to clearly state these in the notice, etc. He also stated that it is important to avoid lag loss in the future, and that it is important to avoid the occurrence of lag loss. He expressed his view that in the future, it will be necessary to consider both the prevention of lag loss and the handling of items that have already become lag loss, and that issues such as increasing revenue, post-marketing burdens, and mitigating safe supply risks will become challenges.

Next, Mr. Takeshi Yanagimoto of Boston Consulting Group Japan gave a presentation entitled "Future Vision of Pharmaceutical Regulatory Reform: Considerations from the "Study Group on the Drug Regulatory System for Strengthening Drug Discovery Capability and Ensuring Stable Supply" and explained that the study group was successful because of the expert study group, the declaration to strengthen drug discovery capability in the government's Framework Policy for He introduced that the reason for the success of the study group was that it attracted attention from society due to the issues of stable supply and lag loss. He also expressed his view that new drugs of new modalities may cause further lag loss in the future, and that it is necessary to address this issue as soon as possible.

During the panel discussion, there was an opinion that it is necessary to verify whether the notifications issued in response to the study group are being properly implemented by both the companies and the government. It was also commented that it is necessary to consider how to optimize the system in the future, taking into account Japan's international standing. He concluded by saying that the continuation of what was discussed at this meeting is being continued by the Pharmaceuticals and Medical Devices System Subcommittee, which is considering revisions to the Pharmaceutical Affairs Law, and that it is important to keep a future-oriented perspective and discuss the issue when necessary.

Symposium 10

Achieving the Global Standard's Risk-Based Approach to the Procedural System for Changing Approval Matters Relating to Quality

Next, Mr. Yoshio Nakayama, a member of the Pharmaceutical Affairs Committee of the Pharmaceutical Affairs Association of Japan, presented the results of the "Survey on Approval and Change Procedures Conducted by the Pharmaceutical Affairs Committee of the Pharmaceutical Affairs Association of Japan", explaining the actual use of Established Conditions stipulated in the ICH Q12 Guidelines in the US and Europe, the "Risk-Based Change" and "Risk-Based Change". The results of a questionnaire survey on the actual use of the Established Conditions stipulated in the ICH Q12 Guideline in Europe and the U.S., the attitudes of JCIA member companies toward "risk-based changes," and the perception of the unique Japanese system from the perspective of Western companies (parent companies of foreign companies, partners of domestic companies, etc.) were presented. He also stated the need to realize an optimal system that can provide a stable and continuous supply of high-quality pharmaceutical products.

Next, Mr. Masahiro Takasuga of the Pharmaceutical Research and Manufacturers of America (PhRMA) introduced the differences in approval items, change management, and change categories in Japan, the U.S., and Europe as "PhRMA's Idea of Approval Item Description and Change Management Related to Quality. The Guideline on Matters to be Described in Marketing Authorization Applications (February 10, 2005, Pharmaceutical and Food Safety Agency Issue No. 0210001) is considered a challenge because it includes items that are not EC items, four categories of changes are considered necessary: prior authorization, notifiable medium risk, notifiable low risk, and no report required. The presentation also stated that a tabular format for approval items would be better and easier to understand internationally, and that harmonization with ICH Q12 would be a good idea.

Next, Ms. Yasuyo Ozaki, Chairperson of the Quality Subcommittee of the Technical Committee of the European Federation of Pharmaceutical Industries and Associations (EFPIA Japan), gave a presentation on "Change Management in Japan from the Perspective of a Foreign Company in Europe (EFPIA)," including the differences between Variation in the EU, examples of Variation in the EU, GMP surveys in Japan and Europe, and risk-based change systems, The presentation was about the risk-based change system. The difference is that in Japan, the change category is set at the time of approval, whereas in the EU, the change category is determined at the time of change, and in the EU, the GMP investigation covers the manufacturing site, whereas in Japan, the investigation covers the product. The EFPIA's opinion was that companies with knowledge and experience should conduct the risk assessment of the change and implement the change.

Next, Mr. Yoshiki Ozawa of the Development Department, Research & Development Division, Sawai Pharmaceutical Co., Ltd. spoke from the standpoint of a generic drug company, explaining the desirability of obtaining prior agreement on changes after reducing gaps by strengthening communication with regulatory authorities through risk visualization as "a risk-based change management system and the direction to be taken. He also stated that risk visualization leads to a better understanding of the product and prompt and appropriate change management. While it is desirable in terms of management and operation that the change procedure system be unified globally, especially for brand-name drugs, it was suggested that there could be more than one approach to the same goal of risk-based change management, such as different operations for generic drugs and other drugs not targeted at overseas markets. The opinion was expressed that there could be more than one approach to the same goal of risk-based change management.

Next, Ms. Sonoko Yamauchi, a member of the Pharmaceutical Affairs Committee, Pharmaceutical Affairs System Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), presented "What is the PMAJ's idea of a risk-based change procedure system for approval items? The other is a system in which the procedural category corresponding to the impact on quality and the risk of change is selected at the time of drafting a change proposal, using examples in the guidelines as an indicator. After the explanation of the Japanese risk-based approach and the Western risk-based approach, a presentation was made on the Pros and Cons of each system. He mentioned that there are differences between globally developed products that require international harmonization and products intended for the domestic market, and proposed a "two-tiered" system that allows each product to choose the pharmaceutical affairs system it requires, as well as examples of descriptions in the manufacturing method section as considered by the Pharmaceutical Manufacturers Association of Japan (PMAJ).

Finally, Mr. Kazunori Takagi, Director of the Generic Drugs Review Department, PMDA, gave a presentation on the issues currently under consideration, including moderate changes, the annual reporting system, risk assessment and change management, one change in the product switching timing setting, and guidelines on items to be included in manufacturing and marketing approval applications (February 10, 2005, Pharmaceutical and Food Safety Bureau, No. 0210001). A presentation was made. He mentioned the recognition of the issues in setting the categories of changes based on actual production results and knowledge and the guidelines for description in the application form, and stated that it is better to have a pharmaceutical system that is in harmony with foreign systems rather than to introduce foreign systems.

General presentations <Posters

Poster presentations were made by the Pharmaceutical Affairs Committee of the Pharmaceutical Manufacturers Association of Japan on the following three topics

P-1 Emiko Seki (Japan Pharmaceutical Manufacturers Association, Japan)

Current status of development projects at member companies of the Pharmaceutical Affairs Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) - Considerations from the status of global development implementation

P-4 Yoshikazu Yamamoto (Japan Pharmaceutical Manufacturers Association, Pharmaceutical Affairs Committee, Regulatory Affairs Subcommittee)

Questionnaire on the Status of Review of New Drugs 2024

P-21 Makoto Fujikawa (Japan Pharmaceutical Manufacturers Association, Pharmaceutical Affairs Committee, Pharmaceutical Affairs System Subcommittee)

Expansion of the Standard Verification Certificate System and Further Streamlining of the GMP Conformity Assessment System - Consideration from the Standpoint of Manufacturers and Distributors

Closing Remarks

The "Study Group on the Ideal Pharmaceutical Regulation System to Enhance Drug Discovery and Ensure Stable Supply" held in FY2023 discussed the resolution of the drug lag/drug loss problem, promotion of pediatric drug development, the ideal pharmaceutical affairs review process for drug manufacturing methods, and the ideal use of real-world data in the pharmaceutical affairs system. From 2024, the Pharmaceuticals and Medical Devices System Subcommittee has been discussing and examining the next revision of the system.

At the 2024 Annual Meeting, a symposium was held to discuss the contents of the study by the "Study Group on the Regulatory System for Pharmaceutical Affairs," and numerous active discussions were held from various perspectives. It is expected that the promotion of regulatory science and further cooperation between industry, academia, and government will be further promoted through these activities, and it is hoped that regulatory science will further develop and the activities of the society will become more and more active.

(Yutaka Takeuchi, Masayuki Tagami, Kozue Shimizume, and Akinobu Nakanishi, Pharmaceutical Affairs Committee)

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