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The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and
T Tominaga1, S Miyazaki1, Y Oniyama1
1Pharmaceuticals 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.
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