Has risk management plan system influenced the speed of package insert revisions in Japan?

IntroductionThe system of Risk Management Plan in Japan (J-RMP) is a relatively new system, implemented in 2013; thus, its effect on safety measures is still unclear. One of the purposes of J-RMP is to enhance the postmarketing safety measures to be ensured by publishing J-RMP and sharing informatio...

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Bibliographic Details
Main Authors: Natsuko Kameyama, Aoi Hosaka, Hideki Maeda
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-10-01
Series:Frontiers in Medicine
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmed.2024.1465313/full
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