The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on three key service areas: relief services for persons suffering from adverse health effects, product reviews, and safety measures. The PMDA provides these three services in an integrated manner, which is referred to as the "safety triangle" system. Through this system, the risks of medical products including drugs and medical devices are continually managed not only in the pre-approval 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. To this end, in order to build a wide-ranging network of cooperation with those at the forefront of scientific advancement, in April 2015 the PMDA began to enter into comprehensive partnership agreements with medical and research institutions conducting high-quality clinical research.
To facilitate the practical use of innovative drugs and medical devices, the PMDA offers the Pharmaceutical Affairs Consultations on R&D Strategy to academic institutions and venture companies that possess promising seed-stage resources, providing them with advice on matters from the initial stage of product development through to clinical trials. The PMDA, in collaboration with the Japan Agency for Medical Research and Development established in April 2015, will make every effort to support the practical application of innovative drugs and medical devices. In response to the launch of the SAKIGAKE Designation System, the PMDA will further strengthen the collaboration with the Ministry of Health, Labour and Welfare in order to promote the practical application of innovative drugs and medical devices ahead of the rest of the world.
In addition, the PMDA is striving to create electronic medical information databases for the development of new approaches to safety measures, while accumulating electronic clinical study data submitted for new drug applications to build a system for Advanced Review and Consultation with Electronic Data in which the Agency itself analyzes data using advanced techniques. These activities are intended to enhance the quality of the Agency's product review and safety monitoring.
The PMDA's initiatives presented above have been highly regarded around the world. Further, in April 2016, the PMDA launched its Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, to further contribute to the advancement of effective medical product regulation throughout the Asian regulatory community by offering training programs.
Through each of the above activities, the PMDA will continue to endeavor proactively to safeguard and promote the nation's health and safety, while strengthening its partnerships with counterparts in the U.S., Europe, Asia, and other countries and regions. By striving to carry out its duties while incorporating a global perspective, PMDA can contribute to advancing the health and well-being of people around the world.
Tatsuya Kondo, MD, PhD
Pharmaceuticals and Medical Devices Agency