[PMDA]“Rational Medicine” Initiative posted

—serving the best overall interests of the patient through an all-inclusive approach to medicine that is thoroughly based on the latest science and most advanced technology in all relevant areas—

February, 2017

In seeking to make a holistic approach to medicine—an approach that takes the whole spectrum of considerations to account in order to serve the best overall interests of the patient, not just the specialist’s view in a defined area of expertise—the norm, PMDA is pursuing two more specific aims. The first is to provide better insight into the risk/benefit balance of drugs, medical devices, and regenerative medical products by furthering regulatory science. The second is to create a medical environment where the care provided is strictly evidence-based. To achieve these ends, in 2017 PMDA will continue its initiatives in the following four areas. As a result I hope to bring forward the date when the public can begin to enjoy the benefits of the “Rational Medicine” approach. Under this approach the patient will receive optimal medical treatment, including in cases where that treatment is based on innovative new technologies and has only just become available:

  1. Innovation through product approval reviews of enhanced rigor and rationality
  2. Further promotion of regulatory science
  3. Increased sophistication of safety measures through the use of real-world data
  4. Enhanced international partnerships

Link to the “Rational Medicine” Initiative




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