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- Title
International Vision and Strategy for Drug Regulatory Authority: The PMDA's International Vision.
- Authors
Tominaga, Toshiyoshi; Ando, Yuki; Kondo, Tatsuya
- Abstract
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).
- Subjects
JAPAN; PHARMACEUTICAL industry; INTERNATIONAL Conference on Harmonisation; MEDICAL equipment; STRATEGIC planning; GLOBALIZATION
- Publication
Clinical Pharmacology & Therapeutics, 2012, Vol 92, Issue 3, p349
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1038/clpt.2012.90