The Periodic Safety Update Report is where a product’s benefit-risk balance is formally re-argued. Miss the deadline or the format, and a routine obligation becomes a regulatory problem.
The PSUR follows the ICH E2C(R2) Periodic Benefit-Risk Evaluation Report format. Its purpose is not to re-list every adverse event, but to present a critical, integrated evaluation of whether what you knew at authorisation still holds.
The deadlines
Counting from the data lock point as day zero:
- 70 calendar days for PSURs covering intervals up to and including 12 months.
- 90 calendar days for intervals exceeding 12 months.
- 90 days for ad hoc PSURs, unless the request specifies otherwise.
There is no “15-day PSUR” — that figure belongs to expedited individual case safety report submission, an entirely separate obligation. Confusing the two is common and consequential.
The EURD list governs frequency
The EU reference dates list is legally binding and overrules both the default cycle in the legislation and any PSUR frequency condition written into your marketing authorisation. It is updated monthly, and amendments take effect six months after publication. Checking it once at authorisation is not enough — it changes.
Single assessment
Through PSUSA, centrally and nationally authorised products containing the same substance are assessed together, led by the PRAC Rapporteur or an appointed Lead Member State where only national authorisations are involved. Requests for supplementary information typically arrive around day 60 with 30 days to respond. Substances not on the EURD list still require submission via the repository.
Submission
Use of the PSUR Repository has been mandatory since 13 June 2016 for both centrally and nationally authorised medicines. It is not optional, and national submission routes do not substitute for it.
What has changed recently
Commission Implementing Regulation (EU) 2025/1466 amended the implementing rules so that the PSUR must now include updates on the implementation of risk minimisation measures and the results of effectiveness assessments — a meaningful expansion of content. It also formalises the obligation on holders to monitor EudraVigilance. Separately, the Explanatory Note to GVP Module VII was revised in April 2026 and, in practice, is the guidance to follow pending the module’s own update.
How PQRA helps
PQRA prepares and submits PSURs and PBRERs, tracks EURD obligations and manages responses through single assessment.
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