[Post-marketing drug safety-risk management plan(RMP)]

Asami Ezaki; Akiko Hori

[Post-marketing drug safety-risk management plan(RMP)]

Gan To Kagaku Ryoho. 2013 Mar;40(3):279-84.

[Article in Japanese]

Authors

Asami Ezaki¹, Akiko Hori

Affiliation

¹ Pharmaceuticals and Medical Devices Agency, Office of Safety II, Office of New Drug V., Chiyoda-ku, Tokyo, Japan.

PMID: 23507587

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.

Publication types

English Abstract

MeSH terms

Adverse Drug Reaction Reporting Systems*
Antineoplastic Agents / adverse effects*
Databases, Pharmaceutical
Pharmacovigilance*
Risk Management*
Safety Management*

Substances

Antineoplastic Agents