Top News The 19th JPMA Forum" was held.
The JPMA Forum is held once a year to deepen understanding of the pharmaceutical industry by bringing together representatives of various industries closely related to the industry and representatives of member companies for a frank exchange of opinions. The 19th JPMA Forum was held on November 7, 2019 at the Keidanren Kaikan Conference (Chiyoda-ku, Tokyo). This year, we asked Mr. Yasuhiro Fujiwara, who assumed the position of PMDA Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) in April 2019, to deliver a lecture.
Scene at the venue
Part I. Lectures
PMDA Chief Executive Yasuhiro Fujiwara's lecture on "PMDA's New Initiatives - Toward the Realization of the "4 Fs (Firsts)"" is as follows.
The Pharmaceuticals and Medical Devices Agency (PMDA), an independent administrative agency, is responsible for "health hazard remedies" based on the "Pharmaceuticals and Medical Devices Agency Act (PMDA Act)" and the "Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Products (Pharmaceuticals and Medical Devices Act) The PMDA was established in 2004, and at the time of its establishment, the pharmaceutical administration was facing various challenges, such as the "drug lag". However, by strengthening its organization and taking other actions, the PMDA has grown into an organization that is on par with regulatory authorities in Europe and the U.S., and has maintained one of the world's longest review periods for new drugs, enabling it to conduct highly predictable reviews.
Mr. Yasuhiro Fujiwara, PMDA Chief Executive
In FY2019, we have just started our operations based on the Fourth Medium-Term Plan, and it is necessary for us to take on various challenges to further improve the quality of our operations without stopping our progress to date. We will focus on the four "Fs" ("Patient First," "Access First," "Safety First," and "Asia First").
In order to realize the four "Fs," the PMDA must make the best decisions in each of its operations, taking into account the scientific evaluation of risks and benefits over time and the efficacy and safety of products while keeping the clinical field in mind, respond to innovative technologies based on the latest science, improve transparency and provide accurate information to the medical field, patients, and the public, and provide a high quality of service to the public. Various efforts are required to improve transparency and provide accurate information to the medical community, patients, and the public.
In particular, as specific efforts to respond to innovative technologies and products, we have implemented the "Pioneer Review Designation System," "Conditional Accelerated Approval System for Pharmaceuticals," and "Conditional and Time-Limited Approval System for Regenerative Medicine Products" for the early commercialization of new drugs and regenerative medicine products, and also established the Regulatory Science Center and established the "Scientific Committee" and "Scientific Committee" for the early commercialization of regenerative medicine products. In addition, the Pharmaceuticals Association of Japan (PAK) has established the Regulatory Science Center, which aims to improve its ability to respond to innovative technologies through the implementation of the "Scientific Committee" and "Horizon Scanning" programs.
The JPMA is an association of R&D-oriented pharmaceutical companies that aims to contribute to the improvement of human health in Japan and around the world through the development of innovative and highly useful pharmaceutical products and the sound growth of the pharmaceutical industry. Safety First," "Asia First," and "Patient First") are exactly the path that the JPMA should take.
Part II Round-table Discussion
Following the opening remarks by JPMA Chairman Yuzuru Nakayama, the meeting was addressed by Mr. Toshifumi Kojima, Parliamentary Secretary to the Minister of Health, Labour and Welfare, representing the Ministry of Health, Labour and Welfare; Mr. Hiroshi Hatori, Executive Director, representing the Japan Medical Association; Mr. Nobuo Yamamoto, Chairman, representing the Japan Pharmaceutical Association; and Mr. Shinsuke Amano, President, National Association of Cancer Patients' Organizations, representing patient groups. Mr. Shinsuke Amano, President of the National Federation of Cancer Patients' Associations, gave a speech.
Minister of Health, Labour and Welfare Mr. Toshifumi Kojima
Executive Director, Japan Medical Association Dr. Yutaka Hatori
Chairman, Japan Pharmaceutical Manufacturers Association
Mr. Nobuo Yamamoto
National Federation of Cancer Patients' Associations Mr. Shinsuke Amano, President
JPMA
Joji Nakayama, Chairman
The banquet was opened with a toast by Mr. Isao Teshirogi, Chairman of the Federation of Pharmaceutical Manufacturers' Associations of Japan, followed by words of hope and encouragement for the pharmaceutical industry from more Diet members than in previous years. The packed hall was filled to overflowing with the enthusiasm of the many participants, and the circle of conversation filled the hall. After the closing speech by JPMA Vice President Yasufumi Okada, the conversation continued, and the 19th JPMA Forum was successfully concluded with a great success.
Chairman, Japan Federation of Pharmaceutical Manufacturers' Associations Mr. Isao Teshirogi
JPMA
Yasushi Okada, Vice Chairman
Scene of the Roundtable Meeting
（The 19th Pharmaceutical Manufacturers Association Forum was a great success.)