The Pharmaceuticals and Medical Devices Agency (PMDA) plays three key roles—relief services for persons injured by adverse reactions to drugs and regenerative medical products, product reviews, and safety measures. PMDA is engaged in ensuring the quality, efficacy, and safety of medical products—drugs, vaccines, biologics, medical devices, and regenerative medical products, from development to post-market stages, in order to provide citizens and healthcare professionals with rapid access to safer, more effective medical products, and to ensure their safe use.
PMDA is responsible for evaluating, from various perspectives, the latest scientific findings regarding the quality, efficacy, and safety of medical products to assess the advantages and disadvantages of individual products, and for providing medical products to the public in the most optimal way so that people can benefit from them with a sense of security. PMDA staff is committed to performing their duties, keeping in mind that many patients are now waiting for novel therapies, but even so, giving the public access to novel therapies in the best way requires a certain period of time. PMDA is a science-based organization and must deal with emerging and future innovative technologies in a timely manner, while giving top priority to the safety of people.
To this end, PMDA carries out operations promptly and carefully from the scientific point of view by promoting regulatory science, a scientific discipline that enables sound, evidence-based review and evaluation. Further, through enhanced transparency, PMDA strives to accurately communicate its decisions with evidence to all people in Japan, including healthcare professionals and patients.
Relief systems for persons injured by adverse reactions to drugs and regenerative medical products are highly regarded internationally and is the source of Japanese pride, our precious asset. PMDA will carry on with offering support to people who have suffered injuries related to drugs and regenerative medical products.
Today, PMDA is recognized as a regulatory authority standing shoulder-to-shoulder with its counterparts in Europe and the United States. We look forward to playing an active role in discussions on international harmonization of regulations, and will contribute to raising standards at Asian and other regulatory authorities.
PMDA will strive to enhance the quality of operations based on regulatory science and, without being bound by precedents, will proactively address new challenges with a scientific approach, to contribute to the advancement of the public health and safety of all people in Japan.
Yasuhiro FUJIWARA, MD, PhD
Pharmaceuticals and Medical Devices Agency
Toward the realization of “4Fs (Firsts)”