The Journal of Science Policy and Research Management
Online ISSN : 2432-7123
Print ISSN : 0914-7020
Conflict between Progress of Clinical Research and Regulatory Obstacles in Japan(<SPECIAL REPORT>LAW, REGULATION, SYSTEM AND MEDICAL INNOVATION)
Yasuhiro FUJIWARA
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2015 Volume 30 Issue 1 Pages 32-42

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Abstract
I analyzed regulations and systemic burdens that act as barriers against the conduction of innovative drug/device development and against the promotion of high-quality clinical research and trials. Taking into account the wide range of these issues, I will propose a plan that will allow for both the promotion of innovation, clinical research, and clinical trials and the maintenance of the national healthcare system. By urgently completing this process of comprehensive systems-based planning, I hope to realize futuristic medicine (precision medicine and personalized medicine), which allows for genetic information to be used freely while maintaining the structure of the national health care system.
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2015 Japan Society for Research Policy and Innovation Management
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