The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on three key areas: relief services for adverse health effects, product reviews, and safety measures. These three encompass the entire life cycle of drugs and medical devices from development through the post-marketing period. This so-called “safety triangle” system, which contributes to public health, is unique to Japan. Under this system, the PMDA is committed to fulfilling its responsibilities 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 estimation, 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 Joint Graduate School Program and the pursuit of regulatory science research. In fiscal 2012, PMDA started to strengthen its organizational structure to handle state-of-the-art technology products more appropriately through closer links with academic and healthcare professionals who are engaged in cutting-edge scientific research. Such efforts include the personnel exchange program between the PMDA and universities and research institutions under the initiative to facilitate development of innovative drugs, medical devices, and cellular and tissue-based products, and the establishment of the Science Board consisting of external experts who are serving on the front lines of medical, pharmaceutical, and dental sciences.
The PMDA has been committed to facilitating the development of innovative products by providing 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. International regulatory harmonization is becoming essential to fulfill our mission, as globalization advances in the pharmaceutical and medical device industries. Therefore, the PMDA has been actively promoting international activities in line with the PMDA International Strategic Plan.
The Japan Revitalization Strategy and the Healthcare and Medical Strategy, which were released by the Japanese Government in June 2013, clearly illustrate the goal of developing and expanding the healthcare and aging-care industries, thereby leading to the extension of the nation’s healthy life expectancy. To attain this goal, the development of innovative drugs, medical devices, and cellular and tissue-based products, as well as their introduction to the market after the completion of prompt regulatory reviews, are necessary. Therefore, as one of the major action plans stated in the national strategies, the PMDA must further speed up and improve its product review process by reinforcing its structure, while ensuring quality and safety measures for products at the post-marketing stage.
The PMDA will sincerely respond to societal demands as the organization responsible for dealing with relief services for adverse health effects, product reviews, and safety measures, while fulfilling its role as one of the world's leading regulatory agencies, thus increasing its presence globally and gaining further trust from Japanese citizens and the rest of the world.
Tatsuya Kondo, MD, PhD
Pharmaceuticals and Medical Devices Agency