The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.
"'Rational Medicine' is the idea that a patient-centric system should be created—a system under which optimal medical care from the patient's point of view, which is based on the latest scientific knowledge, is provided—from the perinatal to the final stages of life," says Kondo, who has served as PMDA's Chief Executive since 2008.
To move toward that ideal, Kondo says PMDA will focus its efforts in four key areas:
- Innovation through product approval reviews
- Further promotion of regulatory science
- Increased sophistication of safety measures through the use of real-world data
- Enhanced international partnerships
After its founding in 2004, PMDA struggled to keep up with other major regulators, and was consistently behind the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the time it took to review new drugs.
However, in recent years, PMDA has made significant strides toward reducing review times, and in 2014, following the introduction of its "Sakigake" designation system for accelerating access to innovative drugs, PMDA surpassed both FDA and EMA in median review times for new drugs.
"[PMDA] will strive to further shorten review times in 2017 through active use of the Sakigake designation system," Kondo says.
As part of its regulatory science efforts, Kondo says PMDA's Science Board will focus on three areas in 2017: better methods for assessing clinical studies for rare drugs, identifying areas of research that "bottleneck" drug development and looking into the use of artificial intelligence technologies in medicine.
Kondo also says PMDA is working to launch a dedicated Regulatory Science Center in 2018.
"This center will actively promote 'Rational Medicine' in collaboration with medical practitioners and academia, working on the basis of regulatory science. Its goal will include the formulation of guidelines to encourage the optimal use of novel medical products with innovative mechanisms of action," Kondo says.
Also in 2018, Kondo says PMDA hopes to make its database for real-world safety data fully operational. According to Kondo, once fully operational the Medical Information Database Network (MID-NET) will be made available to drugmakers and other third parties for use in postmarket surveillance activities.