Abstract
This article reviews DIA activities in Japan, paying particular attention to its efforts to promote the harmonization of regulations. It features the clinical trials and GCP in the East Asia workshop of 1996, which was the first to have representatives from other Asian states share regulatory reform possibilities brought about by the ICH guidelines. Analyzing these harmonization initiatives by DIA and later by other organizations in East Asia, such as APEC and ASEAN, this article reveals a dynamic process in and outside Japan concerning the transformation of its regulatory environment, and confirms the important role DIA plays as a profession-driven organization. In addition, this article argues that DIA, as a mediator and promoter of pharmaceutical affairs, created a platform that facilitates more collaboration between industry and the government. It not only contributed internationally to the excellence of pharmaceutical regulations; upon rapid changes of pharmaceutical regulation and production in East Asia, it should take a more active role in its future efforts for harmonization.
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Tsutani, K., Kuo, WH. & Sato, T. Harmonizing East Asia: The Evolution of DIA in Japan and Its Impact on East Asia. Ther Innov Regul Sci 43, 325–338 (2009). https://doi.org/10.1177/009286150904300312
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DOI: https://doi.org/10.1177/009286150904300312