The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on three key service areas: relief services for adverse health effects, product reviews, and safety measures. The PMDA provides these three services in an integrated manner, which is the "safety triangle" system. Through this system, the risks of medical products are continually managed not only in the preapproval stage, but also in the post-marketing stage. Accordingly, the PMDA is committed to fulfilling its responsibilities and contributing to improvement of public health and safety, in line with its philosophy, which was developed by all its employees.
The PMDA's services are always based on scientific decision- making, which is what regulatory science is about. Regulatory science plays an important role in adapting the achievements of technology to social and human needs in the most optimal way, by making precise prediction, evaluation and judgment based on evidence. The ultimate goal of regulatory science is to benefit society and humankind through better use of technology, while considering the ethical aspects of science. As a leading advocate for regulatory science, the PMDA places emphasis on its advancement. Our activities toward that end include the expansion of the partner network of the Collaborative Graduate School Program and the promotion of regulatory science research. Moreover, the PMDA started to strengthen its organizational structure to handle state-of-the-art technology products more appropriately by encouraging the exchange of personnel between the PMDA and universities or research institutions through the Initiative to Promote Clinical Application of Innovative Drugs, Medical Devices, and Cellular and Tissue-based Products, as well as establishing its Science Board.
The PMDA has also been committed to facilitating the development of innovative products by providing the Pharmaceutical Affairs Consultation on R&D Strategy and by improving safety measures through initiatives such as the collection of electronic medical information and the development of databases. Since international regulatory harmonization is essential for regulators today, the PMDA has been actively promoting international activities in line with the PMDA International Strategic Plan.
Under such circumstances, the Japan Revitalization Strategy published in June 2013, clearly requires that the PMDA strengthen its organizational structure to promote practical application of innovative products ahead of the rest of the world. The PMDA is required to meet societal demands, while responding appropriately to changes in relevant laws such as the implementation of the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (the revised Pharmaceutical Affairs Act) and the Act on Securing of Safety of Regenerative Medicine (both promulgated in November 2013). For this reason, the PMDA strives to speed up and improve its product review process, to ensure product safety, and to focus on the globalization of its operations, thereby fulfilling its role as one of the world's leading regulatory agencies responsible for product reviews and safety measures. To this end, the Agency will make consistent progress by implementing its services, education, and research in a coordinated approach. As described above, the PMDA will endeavor to proactively contribute to improvement of the nation's health and safety, while strengthening partnership with its counterparts in the U.S., Europe, Asia, and other countries and carrying out its responsibilities from global points of view, thus helping improve global public health.
Tatsuya Kondo, MD, PhD
Pharmaceuticals and Medical Devices Agency