International vision and strategy for drug regulatory authority: the PMDA's international vision.

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).