| Budget Amount *help |
¥3,120,000 (Direct Cost: ¥2,400,000、Indirect Cost: ¥720,000)
Fiscal Year 2015: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Outline of Final Research Achievements |
The compassionate use (CU) program is a system that allows official access to unapproved drugs for the purpose of treatment of patients with serious diseases or patients without approved alternative drugs. It allows exceptional use of unapproved drugs for therapeutic purposes under a certain rule from an ethical point of view. The quality management and safety report system is critical for operating CU program safely. This research investigated the operation of medical cannabis under the CU program in the United States from a quality management perspective as a case study. The patient advocacy groups have taken the initiative, establishing a third-party certification system in terms of the standardization of cultivation, manufacturing, laboratory test and distribution of medical cannabis.
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