title: The Japanese Postmarketing Adverse Event Relief System: A Confluence of Regulatory Science, the Legal System, and Clinical Pharmacology.
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.
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Tominaga
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Miyazaki
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Oniyama
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.
authors.forename: A D
authors.initials: AD
authors.lastname: Weber
authors.affiliation: Pharmaceuticals and Medical Devices Agency (PMDA), Chiyoda-ku, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Kondo
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000191:economics / Q000331:legislation & jurisprudence*; D035881:Compensation and Redress / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000191:economics / Q000331:legislation & jurisprudence*; D006801:Humans; D007564:Japan; D010601:Pharmacology, Clinical / Q000191:economics / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing / Q000191:economics; D018570:Risk Assessment / Q000191:economics / Q000331:legislation & jurisprudence