The Pharmaceuticals and Medical Devices Agency (PMDA) focuses on three key service areas: relief services for persons injured by adverse health effects of medical products, product reviews, and safety measures. Through comprehensive management of the lifecycles of drug and medical device products from the earliest stages of development to the post-marketing stage, the PMDA contributes to the improvement of the public health and safety of all people in Japan.
The PMDA has always executed all of its operations with a firm rooting in the concept of “regulatory science,” and has advanced a variety of innovations. As a result, the PMDA has succeeded in shortening its review period for new products, one of the most ambitious objectives set forth in its Third Mid-term Plan*; the new product reviews conducted by the PMDA are now among the fastest in the world. In the future, the PMDA will make every effort to improve public health in Japan by focusing not only on speed, but also on continuously improving the quality and rationality of its operations through further advancement of regulatory science and innovative measures such as strengthening international partnerships.
The PMDA has noted growing expectations regarding its activities in recent years from both Japanese and overseas stakeholders, who demand the development of and access to innovative drug and medical device products. As one of the world’s leading regulatory agencies, the PMDA will steadfastly explore new ideas and tackle the most difficult issues in order to continue to ensure the swiftest possible delivery of safe and effective drugs and medical devices to all people in Japan.
Tatsuya Kondo, MD, PhD
Pharmaceuticals and Medical Devices Agency
*Mid-term Plan: As the PMDA is classified as an agency managed by medium-term objectives, the Mid-term Plans to which the PMDA must adhere are created to reflect medium-term objectives decided by the Minister of Health, Labour and Welfare, and must obtain Ministerial approval to gain effect. The period of implementation of the Third Mid-term Plan extends from April 2014 until March 2019.