1: Basic Program for Science and Technology (approved by the Cabinet on August 19, 2011)https://www8.cao.go.jp/cstp/kihonkeikaku/4honbun.pdf 2: Regulatory science as a bridge between science and society. Clin Pharmacol Ther 90, 29 (2011).10.1038/clpt.2011.89 PubMed 4 In the fourth Science, Technology, and Innovation Basic Plan1, the regulatory science (RS) in association with the promotion of life innovation, is defined as “the science to make precise prediction, evaluation and judgment based on evidence and adapt the achievements of technology to social and human needs in the most optimal way so that the achievements will help people and the society.” In addition, an academic paper2 published by the PMDA in 2011 defined RS as described below. We consider that this is the science to appropriately deliver science and technology-based outcomes (products, new methods and technologies, knowledge, information, etc.) to society. contribute to the effective execution of PMDA's three key operations (Approval Reviews, Post-marketing Safety Japan's pharmaceutical regulations, promote international harmonization, and enable PMDA to play an active role globally. PMDA established RS center in April 2018 to further promote RS for improving the quality of Approval Reviews, Post-consistent support for innovative drugs, medical devices and regenerative medicine products in Japan, from consultation during development to regulatory review and post-marketing safety measures. In addition, PMDA rearranged its organization in July 2023 to strengthen the PMDA's own RS research system. Currently, the RS Center has 4 divisions: Office of Regulatory Science Coordination, Office of Regulatory Science Research, Office of Research Administration, and Office of Medical Informatics and Science (Figure 1). Each office of the RS Center works in cooperation with relevant divisions of PMDA such as review and safety divisions and external organizations to promote RS and utilize the results for the operations of each division, thereby improving the quality of PMDA's operations. Regulatory Science as the science aimed at the optimal introduction into society of new products of science, such as discovered substances and new scientific tools and technologies as well as knowledge and information. We believe that PMDA's proactive promotion of regulatory science research on drugs, medical devices, and regenerative medical products—along with the broad dissemination of our points of view as a Japanese regulatory agency—will Measures, and Relief Services for Adverse Health Effects). Furthermore, it will also enhance public trust in PMDA and marketing Safety Measures. PMDA will actively disseminate scientific evidence and issue guidelines, etc. to provide 2. Introduction 2.1 What is Regulatory Science? 2.2 RS Center
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