Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1):
Introduction:
VII.B. Structures and processes
VII.B.1. Objectives of the periodic update safety report (PSUR)
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.5.7.1. 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.3.3.3. 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.4.2.4. 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.5.3. PSUR EU regional appendix, sub-section “Summary of ongoing
safety concerns”
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.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.Appendix 1. Examples of tabulations for estimated exposure and
adverse events/reactions data