Top News The 19th Pharmaceutical Association of Japan Forum
The Pharmaceutical Manufacturers Association of Japan (PMAJ) Forum is held annually to deepen understanding of the pharmaceutical industry by bringing together representatives of various industries closely related to the industry and representatives of member companies to engage in a frank exchange of opinions. The 19th Pharmaceutical Cooperative Forum was held on November 7, 2019 at the Keidanren Kaikan Conference Hall (Chiyoda-ku, Tokyo). This year, we asked Mr. Yasuhiro Fujiwara, who assumed the position of President of the Pharmaceuticals and Medical Devices Agency (PMDA) in April 2019, to deliver a lecture.
Scene at the venue
Part I: Lecture
The following is a summary of the speech given by Yasuhiro Fujiwara, President of PMDA, on "PMDA's New Initiatives - Toward the Realization of the "4 Fs (Firsts)"".
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 MHLW has grown into an organization that is on par with regulatory authorities in Europe and the United States, and has been able to maintain the world's top level of review times for new drugs and achieve highly predictable reviews.
Mr. Yasuhiro Fujiwara, President, PMDA
In FY2019, we have just started our operations based on the Fourth Medium-Term Plan, and it is necessary for us to take on further challenges to improve the quality of our operations without stopping the progress we have made to date, and we are committed to the four "Fs" ("Patient First," "Access First," "Safety First," and "Asia First"). 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 Early Approval System for Pharmaceuticals," and "Approval System for Regenerative Medicine Products with Conditions and Deadlines" for the early commercialization of new drugs and regenerative medicine products, and also established the Regulatory Science Center. 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 Pharmaceutical Manufacturers Association of Japan (PMDA) 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. The PMDA's new four Fs ("Patient First," "Access First," "Safety First," and "Asia First") are exactly the path that the Pharmaceutical Manufacturers Association of Japan (PMAJ) should take.
Part II: Roundtable Discussion
Following the opening remarks by Mr. Yuzuru Nakayama, Chairman of the Pharmaceutical Manufacturers Association of Japan (PMAJ), the round-table discussion was addressed by Mr. Toshifumi Kojima, Parliamentary Secretary of the Minister of Health, Labor and Welfare, representing the Ministry of Health, Labor and Welfare, Mr. Hiroshi Hatori, Executive Director, representing the Japan Medical Association, Mr. Nobuo Yamamoto, President, representing the Japan Pharmaceutical Association, and Mr. Shinsuke Amano, President, National Association of Cancer Patient Organizations, representing patient groups. Guest of honor addresses were given by Mr. Shinsuke Amano, President of the National Federation of Cancer Patients' Associations.
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
Pharmaceutical Manufacturers Association of Japan
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 Yasushi Okada, Vice President of the Pharmaceutical Manufacturers Association of Japan (PAPJ), the participants continued to exchange pleasantries, and the 19th PAPJ Forum came to a successful conclusion.
Chairman, Japan Federation of Pharmaceutical Manufacturers' Associations Isao Teshirogi
Pharmaceutical Manufacturers Association of Japan
Yasushi Okada, Vice Chairman
Scene of the Roundtable Discussion
（The 19th Pharmaceutical Manufacturers Association Forum was a great success.)