Adverse drug reaction (ADR) relief system in Japan is comprehensively described in this article. Particularly, review process during ADR relief evaluation is focused from clinical perspective. The significance of clinical review process and roles of a physician medical reviewer in the ADR relief system in Japan are also discussed. The current ADR Relief Service in Japan requires criteria for compensation eligibility including the “proper” use of the medication associated with the adverse event, and reasonably plausible association between the drug and the adverse event. The criteria are primarily reviewed at the ADR relief department of Pharmaceuticals and Medical Devices Agency (PMDA). In this article, after introducing framework of the ADR relief system in Japan including review processes at PMDA, actual process of the ADR relief assessment is described. In more details, we explain appropriate indication and appropriate usage in the ADR relief evaluation and unexpected/unwritten ADR in the Japanese package insert. Also described are time period for the payment, causality assessment between ADRs and the death, and pitfalls during the evaluation of the ADR relief system in Japan. In the last part, current issues and future directions are referred.
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The authors would like to thank all the staff members in the ADR Relief Department.
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Watanabe, M., Nishikawa, H., Miyasaka, N. et al. Adverse Drug Reaction Relief System in Japan: From Clinical Perspective. Ther Innov Regul Sci 54, 731–737 (2020). https://doi.org/10.1007/s43441-019-00003-7
- ADR relief system
- ADR causality assessment
- Physician medical reviewer
- Pharmaceuticals and Medical Devices Agency
- ADR relief department