Office of International Programs, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Clin Pharmacol Ther. 2012 Sep;92(3):349-51. doi: 10.1038/clpt.2012.90. Epub 2012 Aug 8.
The past several years saw various countries' drug regulatory authorities (DRAs) internationalizing their activities in response to the rapid globalization of pharmaceutical affairs. This is the second surge of internationalization, coming after the first in the 1990s, when the International Conference on Harmonisation (ICH) and the Global Harmonization Task Force were founded. For maximum effect, a DRA needs to carefully strategize its international activities. The significance of international master plans is discussed in relation to the recently published International Vision of Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
过去几年，各国药品监管机构（DRAs）为应对医药事务的快速全球化，纷纷开展国际化活动。这是继 20 世纪 90 年代第一次国际化浪潮（即国际协调会议（ICH）和全球协调工作组（GHTF）成立）之后的第二次浪潮。为达到最佳效果，DRAs 需要精心策划其国际化活动。本文将讨论制定国际总计划的重要性，并结合最近发布的日本药品和医疗器械管理局（PMDA）的《国际视野》进行说明。
