Periodic Reports (PSUR, PBRER, DSUR)
Preparing and submitting periodic safety reports on time — with a common thread rather than a collection of text.
What are periodic safety reports?
In periodic reports, the marketing authorisation holder summarises all safety data for a given period and re-evaluates the benefit-risk balance. For authorised medicinal products this is the PSUR or PBRER; for medicinal products in clinical development it is the DSUR.
Why does it matter?
These reports are subject to deadlines and are assessed centrally. A missed submission is immediately visible and cannot be smoothed over afterwards. In terms of content, it stands out when a report is merely a collection of tables: what is expected is a continuous line of argument from the data lock point through the available data to the conclusion.
Who needs it?
Marketing authorisation holders with products subject to PSUR requirements, sponsors of clinical trials subject to DSUR requirements, and companies that have taken over marketing authorisations and are joining an ongoing reporting cycle.
What do the regulations require?
- GVP Module VII — Periodic Safety Update Reports
- ICH E2C(R2) — format and content of the PBRER
- ICH E2F — Development Safety Update Report
- EURD list — binding data lock points and submission intervals
- Central submission via the PSUR Repository
How VigiPRO supports you
- Preparation of PSURs and PBRERs for authorised medicinal products
- Preparation of DSURs for medicinal products in clinical development
- Planning along the EURD list so that data lock points never come as a surprise
- Evaluation of cumulative data and listings, including reconciliation
- Quality assurance and support through to submission
Why VigiPRO
We do not start writing the report on the deadline. Because single case processing, literature and signal management come together with us, the data basis is in place before the data lock point is reached.
Frequently asked questions
How do we know when our PSUR is due?
From the EURD list. It sets dates and intervals per active substance and is updated continuously — intervals can change even after authorisation.
What is the difference between a PSUR and a PBRER?
PSUR refers to the regulatory obligation, PBRER to the format that applies today under ICH E2C(R2). In practice, the terms are often used interchangeably.
Can you take over an ongoing reporting cycle?
Yes. We review the last report, check the data situation and join the existing cycle. The earlier this happens before the next data lock point, the less rework is needed.
Tell us what it is about — you get a quote, not a brochure.