Department of Innovative Drug Discovery and Development Division of Regulatory Science

To achieve rapid and safe clinical application of innovative drugs, medical devices, and regenerative medicine products, the Division of Regulatory Science promotes the regulatory science researches related to proper and prompt prediction, evaluation, and judgment of the quality, efficacy, and safety of products based on scientific evidences.” This leads to the development and standardization of the evaluation technology that embodies quality, efficacy, and safety, the clarification of judgment criteria, and the clarification of the scientific requirement for approval reviews.
In addition, this division aims to create innovative drugs by promoting non-clinical studies to connect the basic research results in Japan to clinical trials and also high-quality clinical studies that fully secure science and ethics, as well as research that aims to further activate clinical researches and trials in Japan.