Topics The 12th Annual Meeting of the Regulatory Science Society of Japan" was held

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The 12th Annual Conference of the Regulatory Science Society of Japan was held on September 9 and 10, 2022, at the Academic Center of the National Institute of Informatics (Chiyoda-ku, Tokyo) under the theme of "Current and Future Human Resource Development for Regulatory Science".

Introduction

The Regulatory Science Society of Japan was established in August 2010 with the founding principle of bringing together on an equal footing those involved in the medical field, universities and research institutions, industry, and regulatory authorities 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 organization was established in August 2010. Twelve years have passed since its establishment, and the concept of regulatory science is becoming widely accepted.

The 2022 Annual Meeting was held over two days on September 9 and 10 in a face-to-face format for the first time in two years under the theme of "Current Status and Future of Human Resource Development for Regulatory Science," with lively discussions in the sections of Presidential Address, Special Address, Symposium (13 presentations), and General Abstracts (12 oral presentations and 27 posters). The conference was the first face-to-face meeting on this theme in two years.

Special Lecture 3: The Evolution of the Drug Discovery Ecosystem and Regulatory Science in the Post-Coronary Era

In Special Lecture 3, Mr. Kazuhiko Mori, Executive Director of JPMA, gave a lecture on "The Evolution of the Drug Discovery Ecosystem and Regulatory Science in the Post-Coronavirus Era.

Faced with an extremely large number of challenges due to the pandemic of novel coronavirus infection (COVID-19) that began in 2020, regulatory science has also had to make the most appropriate scientific decisions within the limited time, resources, and information in all processes from drug development to use. demonstrated that it has been faced with new challenges.

In order to make this possible, the entire process from the drug discovery stage at the early stage of development to the post-marketing drug development stage must be viewed as an ecosystem and evolve with the involvement of various stakeholders. The Ministry of Health, Labour and Welfare, Ministry of Health, Labour and Welfare

Symposium 8: Challenges in the Description of Approval Documents for Ethical Drugs

Mr. Takashi Yasukawa, Drug Administration Officer, Medical Care Division, Health Insurance Bureau, Ministry of Health, Labour and Welfare, and Mr. Yuji Kashitani, Chairperson of the JPMA Regulatory Affairs Committee, gave a lecture on the theme of "Issues in the Description of Approval Documents for Ethical Drugs".

Mr. Masatsugu Kobayashi, Chairperson of the JPMA Regulatory Affairs Committee's Regulatory System Subcommittee, spoke on "Issues Related to Description in Approval Forms and Change Management," pointing out that it is time to steer the approval form system in light of changes in the environment surrounding pharmaceutical companies, resolution of issues related to description in approval forms and change management for Quality & Technology Committee and future, and that there are various options for the direction in which the system should be steered, and that an example of such a direction is the global common Establishment of the "Establishment of the World's Leadership in Pharmaceutical Quality and Quality" (EGG). For example, he stressed the need for industry-academia-government discussions on the overall pharmaceutical affairs system, including the GMP system, taking into consideration such issues as the inclusion of the globally common Establishment Condition*1 in the approval form and harmonization of the system regarding CMC with Europe and the U.S.

Also, Dr. Yoshio Nakayama presented the results of a questionnaire survey on the volume of items to be approved in Japan, Europe, and the U.S., the categories of procedural changes in each region when dealing with the same changes in Japan, the U.S., and Europe, the review period, and the implementation status of GMP conformity surveys. He also raised the issue of reconsidering the Japanese pharmaceutical affairs system in light of the current globalized pharmaceutical supply chain.

Next, Dr. Ryoko Naruse, Professor of Pharmaceutical Quality Assurance and Evaluation, Faculty of Pharmaceutical Sciences, University of Toyama, presented an international comparison of GMP inspection methods and perspectives on GMP surveys in Japan based on "Research contributing to qualitative improvement of inspection methods for pharmaceutical quality control based on international consistency". As issues related to approval certificates, he mentioned skills and human resource development of those who audit manufacturers, and fostering a quality-related quality culture at the management level.

Finally, Ms. Yukie Sano of the Pharmaceuticals and Medical Devices Agency (PMDA) introduced cases of inappropriate consultations with the authorities concerning the inclusion of approval forms under the title "Current status and issues of compliance with approval forms in Japan," and requested that companies, including management, promote understanding of the position of approval forms and confirm a communication system for change management in commissioning. The panelists requested that the company's management understand the position of the approval form and confirm the communication system for change management in outsourcing.

In the panel discussion that followed, it was confirmed that the panel would continue to discuss the role of the approval letter in order to achieve the common goal of "providing a stable supply of high-quality pharmaceutical products for patients.

Symposium 10: Regulatory Approval System in an Emergency Situation -Regarding the Practical Application of Domestically Produced Vaccines and Therapeutics

The theme of the panel discussion was "Regulatory Approval System in Emergency Situations - Regarding the Practical Application of Domestically Produced Vaccines and Therapeutics," chaired by Mr. Hiroshi Kasanuki, President of Medical Excellence JAPAN and Mr. Makoto Nagaoka of BeiGene Japan. The theme of the session was "The Drug Approval System in Emergency Situations - Regarding the Commercialization of Domestic Vaccines and Therapeutics.

First, Ms. Noriko Morikubo of Pfizer R&D gave a presentation on actual cases of special approval under the theme of "Development of Cominaty.

Ms. Kashitani, Chairperson of the JPMA Regulatory Affairs Committee, gave a presentation on the importance of close collaboration between the government and companies in utilizing the special approval and emergency approval systems, a proposal for participation in international joint review using the cloud as a means of resolving the lag in approval timing with overseas countries, and expectations for the review process acceleration system under the theme of "For Utilizing the Emergency Approval System (from the company side). Expectations for the Accelerated Examination Process System were also presented.

Next, Professor Katsunori Kai of Waseda University Graduate School of Law made a presentation on "Significance of the 2022 Amendment to the Pharmaceutical Affairs Law for R&D of Domestically Produced Vaccines, etc. - From the Perspective of Regulatory Science and Medical Law" from the perspective of a lawyer on issues in developing an urgent approval system. A presentation was made on issues in the development of the system.

Finally, Yasunori Yoshida, Director of the Drug Evaluation and Control Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, gave a presentation on "Japan's response to the new type of corona and the emergency approval system," introducing the discussions on the administrative side leading up to the establishment of the emergency approval system. A panel discussion with the four speakers followed, during which opinions on the emergency approval system were exchanged from both the corporate and administrative sides, and a lively discussion was held on issues related to the system.

General Abstracts＜Poster

Poster presentations were made by the JPMA Regulatory Affairs Committee on the following four topics

The JPMA Regulatory Affairs Committee presented the results of a survey of 66 member companies regarding projects under development or pending applications as of the end of March 2022. The number of development projects has been gradually increasing since the 2011 survey, with global development accounting for more than 80% of drug development in Japan, and the use of diversified development strategies such as international clinical trials and overseas studies has remained unchanged over the past several years. In terms of development areas, the recent trend is that a large percentage of anti-cancer drugs are being developed in Japan. He also reported on the status of utilization of real world data (RWD), ICH-E17 in global clinical trials, and the status of the Japanese P1 study.

Of the 135 new drugs approved between January and December 2021, the results of a survey of 104 drugs approved by 66 member companies of the JPMA Regulatory Affairs Committee were reported. The median time from application to approval was 11.3 months for regular review items and 8.0 months for non-regular review items. In addition to the status of mandatory submission of electronic data for applications, the level of satisfaction with the review field, and requests for improvement of the review process, the status of special exception approvals for seven items was reported. It was indicated that further use of electronic application data in the review process is expected, and that timely sharing and "visualization" of the progress of review and investigation will lead to further efficiency gains for the regulatory authorities and applicants.

The results of a questionnaire survey conducted in November 2021 among member companies of the Regulatory Affairs System Subcommittee of the JPMA Pharmaceutical Affairs Committee regarding the Standard Confirmation Certificate System, which was introduced when the revised Pharmaceutical Affairs Act came into effect in August 2021, were presented. The survey revealed that there are issues in the operation of the system from the standpoint of manufacturers and distributors, that they do not see the advantages of using the system, and that there are many requests for streamlining the operation of GMP conformity surveys, etc. for pre-approval and export pharmaceutical products. The study also indicated the need to resolve issues in the operation of the Standard Verification Certificate System, to verify the contribution of the introduction of this system to the efficiency of GMP conformity investigations, and to further streamline the GMP investigation system as a whole.

He introduced the results of a questionnaire survey conducted from August to September 2021 among the member companies of the Regulatory Affairs Committee of the JPMA regarding the past five years of regulatory procedures for changes in specifications and test methods for ethical drugs. The "Deletion of items listed in specifications and test methods and changes in specifications" were deleted from the changes that were excluded from the "scope of minor changes in approval items" in Article 47 of the Enforcement Regulations of the Pharmaceutical Affairs Agency Law. While there are cases in which an application for partial change is required when test characteristics cannot be confirmed after the change, examples of cases that can be handled with a Minor Change Notification through a simplified consultation were presented. It was suggested that if the cases that can be handled by Minor Change Notification could be generalized and presented in notifications, etc., it would lead to more efficient regulatory procedures and examinations, which in turn would contribute to timely change management and stable supply of products. This presentation received the 12th Best Poster Award.

Concluding Remarks

Although the 7th wave of COVID-19 was threatening the holding of this year's Annual Meeting, the poster presentations were divided into two days to prevent infection, and the meeting was held face-to-face for the first time in two years.

The symposium was a lively exchange of opinions among industry, academia, and government, as is the nature of an academic conference, with active comments from the floor. In addition, with the main theme of human resource development for regulatory science, symposiums were held in a wide range of fields, including the construction of a medical information ecosystem, utilization of RWD, programmed medical devices, and projects to promote the practical application of innovative drugs, medical devices, and regenerative medical products, etc., and many discussions from various perspectives were exchanged. The symposiums are expected to promote regulatory science and further collaboration between industry, academia, and government. I hope that the Society's activities will further promote the development of regulatory science.

( Kozue Shimizu, Makoto Fujikawa, Masato Komuro, Yutaka Takeuchi, Regulatory Affairs Committee)

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