title: [Post-marketing drug safety-risk management plan(RMP)].
abstract: The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.
authors.affiliation: Pharmaceuticals and Medical Devices Agency, Office of Safety II, Office of New Drug V., Chiyoda-ku, Tokyo, Japan.
authors.forename: Asami
authors.initials: A
authors.lastname: Ezaki
authors.forename: Akiko
authors.initials: A
authors.lastname: Hori
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D000970:Antineoplastic Agents / Q000009:adverse effects*; D062313:Databases, Pharmaceutical; D060735:Pharmacovigilance; D012308:Risk Management; D017751:Safety Management
chemical_list: D000970:Antineoplastic Agents