EMA GVP Module 8

Guideline on good pharmacovigilance practices (GVP) Module VIII – Post-authorisation safety studies (Rev 3):

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) include provisions for post-authorisation safety studies applicable in the European Union (EU).

A post-authorisation safety study (PASS) is defined in DIR Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

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Table of contents

VIII.A. Introduction

VIII.A.1. Terminology

VIII.B. Structures and processes

VIII.B.1. Principles

VIII.B.2. Study registration

VIII.B.3. Study protocol

VIII.B.3.2. Substantial amendments to the study protocol

VIII.B.4. Reporting of pharmacovigilance data to competent authorities

VIII.B.4.1. Data relevant to the risk-benefit balance of the product

VIII.B.4.2. Reporting of adverse reactions/adverse events

VIII.B.4.3. Study reports 

VIII.B.4.3.1. Progress report and interim report of study results

VIII.B.4.3.2. Final study report

VIII.B.5. Publication of study results

VIII.B.5.1. Submission of manuscripts accepted for publication

VIII.B.6. Data protection

VIII.B.7. Quality systems, audits and inspections

VIII.B.8. Impact on the risk management system

VIII.C. Operation of the EU network

VIII.C.1. Procedure for imposing post-authorisation safety studies

VIII.C.1.1. Request for a post-authorisation safety study as part of the initial marketing authorisation application

VIII.C.1.2. Request for a post-authorisation safety study during a post-authorisation regulatory procedure

VIII.C.1.3. Request for a post-authorisation safety study due to an emerging safety concern

VIII.C.1.4. Joint post-authorisation safety studies

VIII.C.1.5. Written observations in response to the imposition of an obligation

VIII.C.2. Supervision of non-interventional post-authorisation safety studies conducted pursuant to an obligation 

VIII.C.2.1. Roles and responsibilities of the marketing authorisation holder

VIII.C.2.2. Roles and responsibilities of the PRAC and the national competent authority

VIII.C.2.3. Roles and responsibilities of the Agency

VIII.C.3. Changes to the marketing authorisation following results from a non-interventional post-authorisation safety study

VIII. Appendix 1. Methods for post-authorisation safety studies

VIII.App1.1. Study designs

VIII.App1.1.1. Active surveillance

VIII.App1.1.1.1. Intensive monitoring schemes

VIII.App1.1.1.2. Prescription event monitoring

VIII.App1.1.1.3. Registries

VIII.App1.1.2. Observational studies

VIII.App1.1.2.1. Cross-sectional study

VIII.App1.1.2.2. Cohort Study

VIII.App1.1.2.3. Case-control study

VIII.App1.1.2.4. Case-only designs

VIII.App1.1.3. Clinical trials 

VIII.App1.1.3.1. Large simple trials

VIII.App1.1.4. Drug utilisation studies

VIII.App1.2. Data sources

EMA GVP Module 8: