EMA GVP Module 7

Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1):

Introduction:

Periodic safety update reports (PSURs) are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.

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TABLE OF CONTENTS

VII.A. Introduction

VII.B. Structures and processes

VII.B.1. Objectives of the periodic update safety report (PSUR)

VII.B.2. Principles for the evaluation of the risk-benefit balance within PSURs and scope of the information to be included

VII.B.3. Principles for the preparation of PSURs

VII.B.4. Reference information

VII.B.5. Format and contents of the PSUR

VII.B.5.1. PSUR section “Introduction”

VII.B.5.2. PSUR section “Worldwide marketing authorisation status"

VII.B.5.3. PSUR section “Actions taken in the reporting interval for safety reasons”

VII.B.5.4. PSUR section “Changes to reference safety information”

VII.B.5.5. PSUR section “Estimated exposure and use patterns”

VII.B.5.5.1. PSUR sub-section “Cumulative subject exposure in clinical trials”

VII.B.5.5.2. PSUR sub-section “Cumulative and interval patient exposure from marketing experience”

VII.B.5.6. PSUR section “Data in summary tabulations”

VII.B.5.6.1. PSUR sub-section “Reference information”

VII.B.5.6.2. PSUR sub-section “Cumulative summary tabulations of serious adverse events from clinical trials”

VII.B.5.6.3. PSUR sub-section “Cumulative and interval summary tabulations from postmarketing data sources”

VII.B.5.7. PSUR section “Summaries of significant findings from clinical trials during the reporting interval”

VII.B.5.7.1. PSUR sub-section “Completed clinical trials”

VII.B.5.7.2. PSUR sub-section “Ongoing clinical trials”

VII.B.5.7.3. PSUR sub-section “Long term follow-up”

VII.B.5.7.4. PSUR sub-section “Other therapeutic use of medicinal product”

VII.B.5.7.5. PSUR sub-section “New safety data related to fixed combination therapies”

VII.B.5.8. PSUR section “Findings from non-interventional studies”

VII.B.5.9. PSUR section “Information from other clinical trials and sources”

VII.B.5.9 1. PSUR sub-section “Other clinical trials”

VII.B.5.9 2. PSUR sub-section “Medication errors”

VII.B.5.10. PSUR section “Non-clinical data”

VII.B.5.11. PSUR section “Literature” 

VII.B.5.12. PSUR section “Other periodic reports”

VII.B.5.13. PSUR section “Lack of efficacy in controlled clinical trials”

VII.B.5.14. PSUR section “Late-breaking information”

VII.B.5.15. PSUR section “Overview of signals: new, ongoing, or closed”

VII.B.5.16. PSUR section “Signal and risk evaluation”

VII.B.5.16.1. PSUR sub-section “Summary of safety concerns”

VII.B.5.16.2. PSUR sub-section “Signal evaluation”

VII.B.5.16.3. PSUR sub-section “Evaluation of risks and new information”

VII.B.5.16.4. PSUR sub-section “Characterisation of risks”

VII.B.5.16.5. PSUR sub-section: “Effectiveness of risk minimisation (if applicable)”

VII.B.5.17. PSUR section “Benefit evaluation”

VII.B.5.17.1. PSUR sub-section “Important baseline efficacy and effectiveness information”

VII.B.5.17.2. PSUR sub-section “Newly identified information on efficacy and effectiveness”

VII.B.5.17.3. PSUR sub-section “Characterisation of benefits”

VII.B.5.18. PSUR section “Integrated benefit-risk analysis for authorised indications”

VII.B.5.18.1. PSUR sub-section “Benefit-risk context - medical need and important alternatives”

VII.B.5.18.2. PSUR sub-section “Benefit-risk analysis evaluation”

VII.B.5.19. PSUR section “Conclusions and actions” 

VII.B.5.20. Appendices to the PSUR

VII.B.5.21. Mapping signals and risks to PSUR sections/sub-sections

VII.B.6. Quality systems for PSURs at the level of marketing authorisation holders

VII.B.7. Training of staff members related to the PSUR process

VII.C. Operation of the EU network

VII.C.1. PSUR process in the EU - General process

VII.C.2. Standard submission schedule of PSURs

VII.C.3. List of European Union reference dates and frequency of submission of PSURs

VII.C.3.1. Objectives of the EU reference dates list

VII.C.3.2. Description of the EU reference dates list

VII.C.3.3. Application of the list of EU reference dates to submission of PSURs

VII.C.3.3.1. Submission of PSURs for medicinal products: general requirement

VII.C.3.3.2. Submission of PSURs for generic, well-established use, traditional herbal and homeopathic medicinal products

VII.C.3.3.3. Submission of PSURs for fixed dose combination products

VII.C.3.3.4. Submission of PSURs on demand of a competent authority in a Member State

VII.C.3.4. Criteria used for defining the frequency of submission of PSURs

VII.C.3.5. Maintenance of the list of EU reference dates

VII.C.3.5.1. General principles

VII.C.3.5.2. Requests from marketing authorisation holders to amend the list of EU reference dates

VII.C.3.6. Publication of the list

VII.C.3.7. Amendment of the marketing authorisation according to the list of EU reference dates

VII.C.4. Processes for PSUR Assessment in the EU network

VII.C.4.1. PSURs for purely nationally authorised medicinal products

VII.C.4.2. Medicinal products authorised in more than one Member State

VII.C.4.2.1. Assessment of PSURs for a single centrally authorised medicinal product

VII.C.4.2.2. Assessment of PSURs for medicinal products subject to different marketing authorisations containing the same active substance (EU single assessment)

VII.C.4.2.3. Single assessment including at least one centrally authorised product leading to a CHMP opinion

VII.C.4.2.4. Single assessment not including centrally authorised product leading to a CMDh position

VII.C.4.3. Relationship between PSUR and risk management plan

VII.C.4.3.1. PSUR and risk management plan – common modules

VII.C.5. EU-specific requirements for periodic safety update reports

VII.C.5.1. PSUR EU regional appendix, sub-section “Proposed product information”

VII.C.5.2. PSUR EU regional appendix, sub-section “Proposed additional pharmacovigilance and risk minimisation activities”

VII.C.5.3. PSUR EU regional appendix, sub-section “Summary of ongoing safety concerns” 

VII.C.5.4. PSUR EU regional appendix, sub-section “Reporting of results from postauthorisation safety studies”

VII.C.5.5. PSUR EU regional appendix, sub-section “Effectiveness of risk minimisation”

VII.C.6. Quality systems and record management systems for PSURs in the EU network

VII.C.6.1. Quality systems and record management systems at the level of the marketing authorisation holder

VII.C.6.2. Quality systems and record management systems at the level of the European Medicines Agency

VII.C.6.3. Quality systems and record management systems at the level of the competent authorities in Member States

VII.C.7. Transparency

VII.C.7.1. Publication of PSUR-related documents on the European medicines and national medicines web-portals

VII.C.8. Renewal of marketing authorisations

VII.C.9. Transition and interim arrangements

VII.C.9.1. Submission and availability of documents before the Agency’s repository is in place

VII.C.9.2. Quality systems and record management systems at the level of the competent authorities in Member States

VII.C.9.3. Publication of the EU list of union references dates and start of the EU- PSUR single assessment procedure

VII.APPENDICES

VII.Appendix 1. Examples of tabulations for estimated exposure and adverse events/reactions data

VII.Appendix 2. Example of tabular summary of safety signals that were ongoing or closed during the reporting interval

EMA GVP Module 7: