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Introduction of post marketing drug risk minimisation measures in Europe,USA, and Japan and enlightenment to China
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Jing LI1, Xue TANG1, Yong HUANG2, Qiang WANG1
Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(8) : 587 - 594
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Chinese Journal of New Drugs and Clinical Remedies | 2024, 43(8): 587-594
• Policy and Management •
Introduction of post marketing drug risk minimisation measures in Europe,USA, and Japan and enlightenment to China
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Jing LI1, Xue TANG1, Yong HUANG2, Qiang WANG1
Affiliations
  • 1.Bristol-Myers Squibb (China) Investment Co., Ltd., SHANGHAI 200040, China
  • 2.Bristol Myers Squibb Japan, TOKYO 100-0004, Japan
Published: 2024-08-25 doi: 10.14109/j.cnki.xyylc.2024.08.05
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Risk minimisation measure （RMM） is a critical step to maximize the benefit-risk ratio of a medicinal product in pharmacovigilance activities. Through literature review and consulting the websites of major healthcare authorities in Europe Union, the USA, and Japan, this paper reviewed the RMM regulatory requirements and implementation status of these countries and regions. It was found that Europe, the USA, and Japan established relevant regulations earlier and accumulated valuable experience, and the specific implementation and supervision intensity of RMM varied among regions due to differences in medical systems. For example, additional risk minimization measures in Japan and the European Union are presented as risk evaluation and mitigation strategies in the USA. It is suggested that RMM-related regulations and supervision system should be continuously improved, and the marketing authorization holders in China should develop RMM implementation plans that conform to the actual conditions of China based on foreign experience and combined with the current situation of local medical system, and conduct feasible and efficient RMM effectiveness assessment to ensure patient medication safety.

post marketing  /  risk minimisation measure  /  safety  /  pharmacovigilance
Jing LI, Xue TANG, Yong HUANG, Qiang WANG. Introduction of post marketing drug risk minimisation measures in Europe,USA, and Japan and enlightenment to China[J]. Chinese Journal of New Drugs and Clinical Remedies, 2024 , 43 (8) : 587 -594 . DOI: 10.14109/j.cnki.xyylc.2024.08.05
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Year 2024 volume 43 Issue 8
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Article Info
doi: 10.14109/j.cnki.xyylc.2024.08.05
  • Receive Date：2023-03-08
  • Online Date：2026-03-13
  • Published：2024-08-25
Article Data
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History
  • Received：2023-03-08
  • Accepted：2024-05-14
Affiliations
    1.Bristol-Myers Squibb (China) Investment Co., Ltd., SHANGHAI 200040, China
    2.Bristol Myers Squibb Japan, TOKYO 100-0004, Japan
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