Research on compassionate use program from a quality management perspective

2016 Fiscal Year Final Research Report

• Project/Area Number: 26860353
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: Applied pharmacology
• Research Institution: The University of Tokyo
• Principal Investigator: Miayji Tempei 東京大学, 医学部附属病院, 特任助教 (70709568)
• Project Period (FY): 2014-04-01 – 2017-03-31
• Keywords: コンパッショネート・ユース制度 / CU制度 / 未承認薬 / カンナビノイド / 医療用大麻 / 品質管理 / 品質マネジメント / レギュラトリーサイエンス

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.

Free Research Field

臨床データマネジメント、品質マネジメント、レギュラトリーサイエンス