Periodic Safety Update Reports (PSURs) are documents submitted by marketing authorization holders to provide an evaluation of a medicine's risk-benefit balance at defined intervals during the post-authorization phase. PSURs must be submitted within 70 or 90 calendar days depending on the interval and contain information on emerging safety issues, benefit-risk analyses, risk management plans, and sources of safety data. The European Medicines Agency publishes the European Union Reference Dates list which mandates the submission timelines and frequencies for PSURs of specific medicines. A single assessment of PSURs is conducted for medicines with the same active substance.

1. Periodic Safety Update Report
(PSUR)
Dr. Rohith K Nair

2. Definition
• 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. (GVP ModuleVII)
• MAHs responsibility to submit PSURs at defined time points.
• PSURs summarizes the benefits and risks of medicine.
• Evaluation of the benefit-risk balance.

3. History

4. What should a PSUR contain??
• The emerging information - new signals, any identified/ potential
risks etc.
• The summary of safety and efficacy information of the medicine.
• An integrated benefit-risk analysis for all authorised indications.
• The summary of any Risk minimization measures.
• The outline plans for signals or risk evaluations.

5. Is PSUR really a summary??

6. Sources of safety information
• Active surveillance systems
• Clinical trial data
• Competent authorities updates and websites publications.
• Non-clinical studies updates.
• Spontaneous reports, scientific literature/reports, unpublished
manuscripts.
• Post authorisation use in special populations.

7. Content and Format
•Part 1:Title page including signature
•Part 2: Executive Summary
•Part 3:Table of Contents

11. Timelines
• within 70 calendar days PSURs intervals up to 12 months.
• within 90 calendar days - if in excess of 12 months;
• timeline for ad hoc PSURs requested by CA – timeline will be
provided by CA or else 90 days.

12. EURD list
• The European Medicines Agency (EMA) publishes the list of
European Union reference dates and frequency of submission of
PSURs which is known as the ‘EURD list’.
• MAHs submit PSUR mandatorily to NCA - EURD list
• It’s a live document and is amended in a frequency of monthly
(generally)

14. EURD list - Generics
• Generics - Article 10(1) waived to submit PSURs.
• The submission shall be performed as indicated in the EURD list
(Column H for generics).
• Hybrid products – Article 10 (3): PSUR submission not considered
as per the column “H” of the EURD list.

15. PSUR submissions
• As of June 2016, MAHs are required to submit all PSURs in the EU
to the central PSUR repository.
• Use of the PSUR repository is mandatory – single assessment or
National procedure.
• A single assessment of related PSURs is carried out for medicines
that contain the same active substance or combination of active
substances, as per EURD list.

16. PSUR assessment procedure for “EU single
assessment” (PSUSA)

18. Outcome of PSUR Assessment
• A single assessment – published as PSUSA report.
• The outcomes of centrally authorised medicinal products
(CAPs) - European public assessment report (EPAR).
• The outcome of nationally authorised medicinal products
(NAPs) - Community register.

19. Questions

20. References
• GVP module : Guideline on good pharmacovigilance
practices (GVP) ModuleVII – Periodic safety update report
(Rev 1)
• EMA website:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/home/H
ome_Page.jsp&mid=