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Clin Pharmacol Ther. 2017 Aug;102(2):277-282. doi: 10.1002/cpt.537. Epub 2016 Dec 7.

The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.

Author information

1
Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.

Abstract

The Japanese Postmarketing Relief System provides for compensation to patients with adverse reactions, based on the acknowledgment that unpredicted adverse events occur inevitably once a drug is marketed. The system also provides new knowledge about the benefit-risk profile of a drug that may be incorporated into product labeling. The system relies on causality assessments that are based on sound clinical pharmacology principles. The system may serve as a model for other countries' healthcare systems.

PMID:
27737512
DOI:
10.1002/cpt.537
[Indexed for MEDLINE]

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