The Japanese Postmarketing Adverse Event Relief System: A confluence of regulatory science, the legal system, and clinical pharmacology

The Japanese Postmarketing Relief System provides for compensation to patients suffering adverse reactions, based on the acknowledgement 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 system. This article is protected by copyright. All rights reserved.