Collaboration between Japan and Other Asian Countries in New Drug Development: Japanese Industry Perspective
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Collaboration Between Japan and Other Asian Countries in New Drug Development: Japanese Industry Perspective
Kohei Wodo, MSc VP/General Manager, Asia Development Department, Daiichi Sankyo Co.. Ltd.. Tokyo, Japan; JPMA Representative of ICH Steering Committee and Cochair oflCH Global Cooperation Group
Key Words Multinational clinical study; Asia; Non-ICH region Correspondence Address Kohei Wada. MSc. Asia Development Department, Daiichi Sankyo Co.. Ltd.. 1-2-58.Hiromachi. Shinagawa-ku,Tokyo 140m0, japan (email: Wada.kohei.h 7 @ daiichisankyo.co.jp).
'Ihe arena of global clinical trials is expanding into non-ICH regions. Many Asian countries, outside of Japan, have accumulated experience in multinational clinical studies. On the other hand, after achieving high-quality clinical trial mechanisms,Japan is willing to participate more in multinational studies. 'Ihere are good opportunitiesforcdlaboration betweenJapanand other Asian countries. Sometimes, a study accommodating speciic needs of the Asian region is
IN T R ODUCTI0N The global scheme of new drug development has drastically changed in the last 10 years. Due to the increased number of patients required for New Drug Application (NDA) submission and the increased cost of clinical development, many studies are conducted nowadays on a multinational basis. The arena of clinical studies has expanded into regions outside of the International Conference on Harmonization (ICH) such as Asia, Central and South America, eastern Europe, and other regions, with the introduction of the ICH-Good Clinical Practice (GCP) guideline being the trigger of this trend.
JAPANESE CLINICAL TRIAL E N V l R O NMENT: P ER S O NA L 0 BS E R V A T I O N In the meantime, Japan struggled to cope with the new GCP environment that was introduced in 1997. The government, industry, and medical institutions seriously pursued compliance with the ICH-GCP concept and guideline, and generated a meticulous but high-quality system to ensure reliability of clinical data. The Japanese culture of perfectionism accelerated the effort. Consequently, the current Japanese clinical trial environment became labor intensive and slow,
more justified than a global study 'Ihe Asian region can contribute more on the scientific side, participating in the earfier phases of drug development. Complementary cdlabomtion is possible with Japan providing know-how in eady drug evaluation and other Asian counties providing experience in multinational clinical studies. Asian regulatory networks and adivities of the ICH Global Cooperation Group are also expected to enhance such an environment.
thus making it very costly to conduct clinical studies. In terms of multinational studies, Japan has not been an enthusiastic participant. In addition to the GCP struggle mentioned above, other reasons such as rigid regulatory requirements for clinical data generated in Japanese populations and the downsizing of the relative Japanese share within the global market also caused reluctance to participate in multinational studies. Aft
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