Concept of Routine Pharmacovigilance, Especially Signal Management in the US and Europe

Keiko Ohga; Takako Sugita; Akihiro Seki; Teruyuki Honda; Genta Kawaguchi

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Concept of Routine Pharmacovigilance, Especially Signal Management in the US and Europe

VernacularTitle:通常の医薬品安全性監視，特にシグナル管理に関する欧米の考え方について ―日本医療研究開発機構（医薬品等規制調和・評価研究事業)「医薬品リスク管理計画制度の充実と効果の向上のための基盤研究｣―（AMED RMP 研究班）
Author: Keiko OHGA ¹ ; Takako SUGITA ² ; Akihiro SEKI ³ ; Teruyuki HONDA ⁴ ; Genta KAWAGUCHI ⁵
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1. JPMA（Pharmacovigilance, Astellas Pharma Inc., Japan)
2. PhRMA Japan（Pharmacovigilance, Medical, AbbVie GK, Japan)
3. EFPIA Japan（Oncology Lifecycle Management Department, Project & Lifecycle Management Unit, Chugai Pharmaceutical Co., Ltd., Japan)
4. PhRMA Japan（Safety Risk Management, Japan pharmacovigilance, MSD K.K., Japan)
5. EFPIA Japan（Safety Risk Management, Jansen Pharmaceutical K.K., Japan)
Keywords: Risk Management Plan（RMP); routine pharmacovigilance; signal management
From:Japanese Journal of Pharmacoepidemiology 2021;26(2):26.e6-
CountryJapan
Language:Japanese
Abstract: Monitoring of the safety profile for the approved medical products consists of routine pharmacovigilance activities for all drugs and additional pharmacovigilance activities for product-specific concerns. Signal management is an important part of routine pharmacovigilance activities, so EMA and FDA have published the guidelines for signal management in various documents. The AMED Risk Management Plan （RMP） research group, which started its activities in 2018 to enhance risk management plan in Japan, reviewed the guidelines and related articles and then put together the principles of signal management. The guidelines in EU and US describes the signal detection and evaluation methods including points to consider when conducting them, responsibilities of each action, and the procedures that the regulatory authorities disclose the outcome of their activities, in addition to the principles and procedures of signal management. Through the guidelines, they establish transparency for public including pharmaceutical industry. Our group first created the Japanese definitions of signal-related terms. Based on them, we created high-level concept for a series of activities from signal detection to risk identification and discussed the future vision of signal management in Japan.