Greetings

Since its establishment in April 2004, the Pharmaceuticals and Medical Devices Agency (PMDA) has focused on the three key areas of relief services for adverse health effects, product reviews, and post-marketing safety measures, encompassing the entire life cycle of drugs and medical devices from development through to the post-marketing period. This so-called “safety triangle” system, which contributes to public health, is unique to Japan. Under such a system, PMDA is committed to fulfill its duties in line with its Philosophy.

To facilitate regulatory activities focused on scientific decision making, PMDA, as its leading advocate, places emphasis on the promotion of regulatory science. The goal of regulatory science is to apply academic science to clinical practice in a useful manner, thereby contributing to society. To this end, it is necessary for PMDA to broaden its links and personnel exchanges with academia, healthcare organizations, and industry. As part of such efforts, PMDA is working to expand the partner network of the Joint Graduate School Program.

In the midst of the globalization of the pharmaceutical and medical device industries, international regulatory harmonization is essential to the achievement of PMDA’s mission. Therefore, PMDA established the Office of International Programs to bolster its international activities in line with the PMDA International Strategic Plan developed in 2009.

In order to achieve realization of innovative drugs and medical devices originating from Japan, PMDA started the Pharmaceutical Affairs Consultation on R&D Strategy in fiscal 2011 as a new initiative intended to promote the commercial application of promising “seed” research and technologies.

PMDA will continue to work hard to serve as the Japanese regulatory agency that deals with relief services for adverse health effects, product reviews, and post-marketing safety measures, while acting as one of the world’s leading regulatory agencies.

September 2011
 
Tatsuya Kondo, M.D., Ph.D.
Chief Executive
Pharmaceuticals and Medical Devices Agency (PMDA)