Asahina Yasuko, Tanaka Ayumi, Uyama Yoshiaki, Kuramochi Kenji, Maruyama Hiroshi
1 Regulatory Science Research Division, Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
2 Office of Regulatory Science, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan.
Ther Innov Regul Sci. 2013 Jan;47(1):19-22. doi: 10.1177/2168479012469950.
Recently, it is becoming increasingly difficult to develop innovative drugs. Thus, the role of regulatory science research in drug development and postmarketing settings has become more important. In this article, the authors discuss the roles of regulatory science research at the Pharmaceuticals and Medical Devices Agency (PMDA), which aims to improve public health in Japan.
近年来，开发创新药物变得越来越困难。因此，监管科学研究在药物研发和上市后阶段的作用变得更加重要。在本文中，作者讨论了药品和医疗器械管理局（PMDA）的监管科学研究的作用，该机构旨在改善日本公众的健康状况。
