EMA GVP Module 9

Guideline on good pharmacovigilance practices (GVP) Module IX – Signal management (Rev 1):

Introduction:

Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter III].

In this Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.

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Table of contents

IX.A. Introduction

IX.A.1. Terminology

IX.A.1.1. General terminology

IX.A.1.2. Terminology specific to the EU signal management process with oversight of the Pharmacovigilance Risk Assessment Committee (PRAC)

IX.B. Structures and processes

IX.B.1. Sources of data and information 

IX.B.2. Signal detection

IX.B.3. Evaluation during signal validation and further assessment

IX.B.4. Signal prioritisation

IX.B.5. Quality requirements

IX.C. Operation of the EU network

IX.C.1. Roles and responsibilities

IX.C.1.1. Responsibilities of the marketing authorisation holder in the EU

IX.C.1.2. Responsibilities within the EU regulatory network

IX.C.2. Emerging safety issues 

IX.C.3. Monitoring of EudraVigilance data

IX.C.3.1. Principles for access

IX.C.3.2. Periodicity of monitoring

IX.C.3.3. Analysis of EudraVigilance data 

IX.C.4. Notifications and procedural options for signals detected by the marketing authorisation holder in the EU based on the continuous monitoring of EudraVigilance data

IX.C.4.1. Variation of the terms of marketing authorisation

IX.C.4.2. Inclusion of the signal in the periodic safety update report (PSUR)

IX.C.4.3. Standalone signal notification

IX.C.5. Signal confirmation by the PRAC rapporteur or (lead) Member State

IX.C.6. Signal analysis, prioritisation and assessment by the PRAC

IX.C.7. Recommendations on signals from the PRAC

IX.C.8. Record management in the European Pharmacovigilance Issues Tracking Tool (EPITT)

IX.C.9. Transparency

IX. Appendix 1. Figures on the EU signal management process

EMA GVP Module 9: