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

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


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.

Publication types

  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / economics
  • Adverse Drug Reaction Reporting Systems / legislation & jurisprudence*
  • Compensation and Redress / legislation & jurisprudence
  • Drug Labeling / economics
  • Drug Labeling / legislation & jurisprudence*
  • Humans
  • Japan
  • Pharmacology, Clinical / economics
  • Pharmacology, Clinical / legislation & jurisprudence*
  • Product Surveillance, Postmarketing* / economics
  • Risk Assessment / economics
  • Risk Assessment / legislation & jurisprudence