2020 Volume 10 Issue 3 Pages 139-152
Pharmaceuticals and Medical Devices Act (PMD Act) regulates the pharmaceutical products including drugs, medical devices and other related products, and strictly controls new product development, review and approval processes, manufacturing, and post-marketing studies. To achieve medical innovations, researchers in academia as well as those in pharmaceutical industry should be well informed about pharmaceutical regulations and are required to comply with regulatory requirements when conducting preclinical and clinical studies for medical product development. In recent years, academic research organizations (AROs) have been established as university-based organizations that support throughout the process from basic research to practical application, in particular, guiding clinical research and trials in order to promote the development of new pharmaceutical products using academic research findings. Especially in the open innovation model, universities are expected to play an important role. At Osaka City University, we have expanded various research-related ARO functions and services with the catch phrase “Those who master regulation achieve innovation.” In this article, we introduce the institution profile, services and functions of Center for Clinical Research and Innovation (CCRI), an ARO housed in Osaka City University Hospital, and its initiatives to produce innovations from academic research. Academia’s involvement in regulations that interpenetrate with innovations is also discussed.
