TY - JOUR
T1 - Harmonizing East Asia
T2 - The Evolution of DIA in Japan and Its Impact on East Asia
AU - Tsutani, Kiichiro
AU - Kuo, Wen Hua
AU - Sato, Takatoshi
PY - 2009/5
Y1 - 2009/5
N2 - 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.
AB - 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.
KW - DIA
KW - East Asia
KW - GCP
KW - Global drug development
KW - Regulatory harmonization
UR - http://www.scopus.com/inward/record.url?scp=84998146153&partnerID=8YFLogxK
U2 - 10.1177/009286150904300312
DO - 10.1177/009286150904300312
M3 - Article
AN - SCOPUS:84998146153
SN - 2168-4790
VL - 43
SP - 325
EP - 338
JO - Therapeutic Innovation and Regulatory Science
JF - Therapeutic Innovation and Regulatory Science
IS - 3
ER -
