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Greetings,
Established in April 2004, the Pharmaceuticals and Medical Devices Agency (PMDA)provides services focusing on the three key areas of "Relief for Adverse HealthĦĦEffects," "Reviews," and "Post-marketing Safety Measures."
PMDA is involved in various aspects of pharmaceuticals and medical devices, fromĦĦdevelopment to post-marketing use. Our services consist of providing relief to peopleĦĦsuffering from health damages caused by adverse drug reactions and infections fromĦĦbiological products, conducting reviews and related services on pharmaceuticals and medical devices in accordance with the Pharmaceutical Affairs Law, and implementing safety measures.
While issues such as "drug lag" and "device lag" have attracted more attention in recent years, social expectations for PMDA to protect the public health have also risen accordingly. To adequately respond to such issues, PMDA has been increasing the number of review and safety staff so as to resolve "drug lag" and "device lag" as well as to enhance the system for post-marketing safety measures.
In September 2008, PMDA developed its philosophy as a commitment of its staff to share a common goal in their daily work, aiming to pave the way to change to the global PMDA from Japan's PMDA. Keeping the philosophy in mind, we move forward with ceaseless reforms to become the leading regulatory agency in the world.
August 2009
Tatsuya Kondo, M.D., Ph. D.
Chief Executive
Pharmaceuticals and Medical Devices Agency
