Regulatory-required post-marketing database studies in Japan could be leveraged to assess important potential risks as well as identified risks

Regulatory-required post-marketing database studies in Japan could be leveraged to assess important potential risks as well as identified risks

BackgroundTo investigate the characteristics of post-marketing database studies (PMDS) included in risk management plans (RMPs) across all therapeutic areas in Japan.MethodsTwo researchers systematically and independently reviewed all RMPs listed on the Pharmaceuticals and Medical Devices Agency web...

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Bibliographic Details
Main Authors: Hiroshi Yamazaki, Ko Nakajo, Naoki Hirose, Li Yan, Sun Yeop Lee, Yongjing Zhang, Hong Qiu, Chieko Ishiguro
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-07-01
Series:Frontiers in Pharmacology
Subjects:
post-marketing surveillance
drug safety
database study
Japan
pharmacovigilace
risk management plan
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2025.1565314/full
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https://www.frontiersin.org/articles/10.3389/fphar.2025.1565314/full

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