2019年10月12日(土) 10:30 〜 12:10 第1会場 (メインホール)

Chairs: ‌Junko SATO (Pharmaceuticals and Medical Devices Agency, Japan), Shigeto YAMAWAKI (Center for Brain, Mind and KANSEI Sciences Research, Hiroshima University, Japan), Discussant: ‌Tetsuo NAKABAYASHI (Pharmaceuticals and Medical Devices Agency, Japan)

Primary role of regulatory agency is to protect public health through scientific evaluation of drug and biologic products and also medical devices. To ensure the efficacy and safety of medical products based on substantial evidence, regulatory science has grown out of the need to integrate knowledge among basic research, clinical research and clinical medicine. Based on such enormous efforts and experiences on scientific evaluation, regulatory agencies can generate state-of-the-art strategies in the area of regulatory science to accelerate drug development process by making it more adequate and efficient. With greater knowledge about the direction favored by regulatory agencies, researchers and companies can design technologies. Regarding psychiatric fields, there have been many alterations in drug development programs in the past, including the mental disorders studied and complexity of clinical trial designs and data analysis. Such progress results from current advance of research for functional mechanism that underlies central nervous system (CNS) derangement in psychiatric illness. However, there is vast unmet medical need that treatment for patients with mental disorder does not result improvement sufficiently and they often disabled despite existing treatments. These situations can be accounted for in part by increasing diversity in the patients in clinical practice and existing medical products with a limited number of new mechanisms of action, and it is necessary to develop new drugs in the future. Innovative ways to quantify human and animal behavior provide increasing number of CNS targets which may contribute to psychiatric drug development, though it still remains unclear how they relate to symptoms which underlie clinical entities. From this point of view, building regulatory collaboration is strategic activity to foster potentially valuable pharmaceutical technologies and to address public health problems. The objectives of this symposium are discussion for ways of regulatory collaboration after consideration of challenges of regulatory advance for innovation.