Question 8 of 20 Fundamentals Concept
What is a periodic safety update report, and how often is it due?
Short answer
A periodic safety update report (PSUR) is an aggregate review of a marketed product's benefit-risk balance over a set interval, written in the ICH E2C(R2) format called the PBRER. In the EU the timing comes from the list of Union reference dates or the authorisation conditions. In the US, periodic reports are quarterly for 3 years after approval and then annual.
Why
Single case reports show what happened to one patient. A PSUR steps back and asks whether, across all data in the interval and cumulatively, the benefit-risk balance has changed. GVP Module VII uses the ICH E2C(R2) periodic benefit-risk evaluation report structure: exposure, new data from trials, spontaneous reports and literature, signals, risk evaluation, and an integrated benefit-risk conclusion.
In the EU, the submission frequency for an active substance is set in the list of Union reference dates, or in the marketing authorisation. For older products without such a set date, GVP describes a default of 6 monthly reports for the first 2 years on the market, then yearly for 2 years, then every 3 years. In the US, 21 CFR 314.80 requires periodic reports of adverse experiences not sent as 15 day alerts at quarterly intervals for 3 years from approval, then annually.
During development, the parallel document is the development safety update report under ICH E2F.
A strong answer covers
- Aggregate benefit-risk review, not a case listing
- ICH E2C(R2) PBRER format
- EU frequency from Union reference dates or the authorisation
- US quarterly for 3 years then annual
- DSUR as the development counterpart
Common mistakes
- Treating the PSUR as a list of cases without an integrated conclusion.
- Assuming one fixed frequency applies to every product in the EU.
- Confusing the PSUR with the development safety update report.
The interviewer might ask next
What would make you conclude in a PSUR that the benefit-risk balance has changed?