Greetings

 

The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on three key areas: relief services for adverse health effects, product reviews, and post-marketing safety measures. These three encompass the entire life cycle of drugs and medical devices from development through to the postmarketing period. This so-called "safety triangle" system, which contributes to public health, is unique to Japan. Under this system, PMDA is committed to fulfilling its responsibilities in line with its philosophy, which was developed by all its employees.

To facilitate regulatory activities based 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, PMDA needs to have extensive links with academia, medical professionals, and industry. As part of such efforts, PMDA is working to expand the partner network of the Joint Graduate School Program.

In fiscal 2012, PMDA established the Science Board that helps the Agency to handle the scientific and regulatory aspects of state-of-the-art technology products more appropriately through close collaboration with academic professionals engaged in cutting-edge research. The Science Board consists of external experts who are serving on the front line of medical, pharmaceutical, and dental sciences and engineering. The Board, in cooperation with the Office of Review Innovation, has started to discuss the improvement of the review system so that the skills of the reviewers at PMDA can be continuously enhanced.

The advance of globalization in the pharmaceutical and medical device industries has led to increased efforts by the Agency to bring about international regulatory harmonization. PMDA has been actively promoting international activities in line with the PMDA International Strategic Plan.

PMDA is committed to advancing "life innovation," a government policy, by launching the Pharmaceutical Affairs Consultation on R&D Strategy as its new consultation service to support the development of innovative drugs and medical devices originating from Japan, and by reinforcing safety measures through such initiatives as the collection of electronic medical information and database development.

PMDA will continue to work hard as the organization responsible for dealing with relief services for adverse health effects, product reviews, and post-marketing safety measures, while fulfilling its role as one of the world's leading regulatory agencies.

August 2012

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