Topics Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee for 2021" was held
The "FY2021 Joint Assembly of Drug Evaluation Committee and Regulatory Affairs Committee" was held on April 19, 2021 at Muromachi Mitsui Hall & Conference (Chuo-ku, Tokyo). In FY2020, the Spring Assembly was postponed to November 2020 due to the spread of the novel coronavirus, but in FY2021, the Assembly was held at the same time as usual. However, in light of the situation in which the new coronavirus infection has not yet been contained, approximately 50 executives of the JPMA, Drug Evaluation Committee, and Regulatory Affairs Committee participated at the venue as in the previous meeting, while approximately 550 members of the other committees participated online. The meeting was a real sense of the dawn of the new normal.
The venue
The Assembly was opened with an opening address by Yuji Kashitani, Chairperson of the JPMA Regulatory Affairs Committee. The special lectures were given by Mr. Fumio Yamamoto, Deputy Director General, Minister's Secretariat of the Ministry of Health, Labour and Welfare (MHLW) and four others, and one from the Ministry of Education, Culture, Sports, Science and Technology (MEXT), for a total of five lecturers. This was a valuable opportunity to obtain comprehensive information on the latest pharmaceutical administration, including the current status and challenges of the pharmaceutical industry, including the development of a vaccine for new-type coronavirus infection.
Contents of Lectures
Mr. Yamamoto gave a lecture titled "Recent Trends in Pharmaceutical Administration," which covered a wide range of topics from the concept of the "Pharmaceutical Industry Vision 2021," which the MHLW is aiming to formulate in the summer of 2021, to the latest initiatives of the MHLW. He also touched on recent scandals at pharmaceutical companies and strongly urged companies to take the opportunity of the revision of the Pharmaceutical Affairs Law to check their internal systems and establish a governance structure.
Next, Yasunori Yoshida, Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, gave a presentation entitled "Improvement of Evaluation and Management Work and Clinical Trials and Expectations of Companies," covering the first and second year of the revision of the Pharmaceutical Affairs Law, efforts related to approval review (topics related to real world data (RWD) and recent generic equivalent (GE) drugs), and the new strain of the new strain of the drug. ), new coronavirus infection (discussion during emergency response), and other topics.
Junya Kasamatsu, Director of the Research and Development Promotion Division of the Ministry's Medical Affairs Bureau, gave a presentation titled "Development of R&D Promotion and Expectations for Companies," introducing each project of the Pharmaceutical Project as an effort to realize a society where everyone can be active and healthy for a long time, looking ahead to the year 2040. He also spoke about the Ministry of Health, Labour and Welfare's initiatives for innovative drug development and the Clinical Innovation Network (CIN).
Mr. Noriatsu Kono, Director of the Medical Device Review and Management Division, Pharmaceuticals and Consumer Health Bureau of the Ministry, gave a presentation entitled "Development of Medical Devices and Expectations for Companies," introducing the recent approval results of programmed medical devices, DASH for SaMD (Package Strategy to Promote Practical Application of Programmed Medical Devices), the establishment of consultation system for early realization and The presentation also included an explanation of the establishment of a consultation system for early realization and the reinforcement of the system. He also spoke about the efficient operation of Type I use of the Law Concerning the Conservation of Biological Diversity through Regulations on the Use of Living Modified Organisms (Cartagena Law) and future improvement measures under consideration.
In the last part of the lecture, Mr. Hiroki Nehashi, Assistant Director, Life Science Division, Research Promotion Bureau, MEXT, gave a presentation titled "Health and Medical Field Research and Development Initiatives by MEXT," introducing the Biobank Utilization Program to Promote Genome Medicine (B-Cure), which includes Tohoku University Tohoku Medical Megabank Organization, which is also conducting joint research with JPMA. He spoke about the MEXT's life science projects, including the Biobank-Centered Approach to Genome Medicine (B-Cure) program, which includes Tohoku University Tohoku Medical Megabank Organization, which is conducting joint research with the Pharmaceutical Cooperative Association. He also indicated that a policy on how to promote research and development of pharmaceuticals and medical devices through industry-academia collaboration is to be compiled by the summer of 2021.
Finally, Chairperson Hironobu Hiyoshi of the JPMA Drug Evaluation Committee concluded the Joint Assembly of the Drug Evaluation Committee and Regulatory Affairs Committee with his closing remarks.
( Kozue Shimizume and Yoshio Nakayama, Regulatory Affairs Committee)