PSUR / PBRER
Periodic Safety Update Report / Periodic Benefit-Risk Evaluation Report
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A PSUR (in EU terminology) — structured on the ICH E2C(R2) PBRER format — is a periodic, cumulative post-authorization report evaluating the benefit-risk balance of a medicinal product using worldwide safety and, where relevant, efficacy data over a defined interval. Its purpose is not merely to list cases but to present an integrated benefit-risk assessment and to identify whether any new information changes the product's established profile. Submission frequency is set by regulation and by the product's risk.
The E2C(R2) PBRER deliberately shifted the periodic report from a case-listing exercise to an evaluative benefit-risk document — the "evaluation" in the title is the point. It integrates signals, cumulative exposure estimates, and any actions taken or proposed.
In the EU, assessment of PSURs for products sharing an active substance can be handled through a single shared assessment procedure, and outcomes can drive regulatory action on the marketing authorization.
- —Periodic, cumulative, worldwide benefit-risk evaluation of an authorized product
- —PBRER (ICH E2C(R2)) is the harmonized format behind the EU PSUR
- —Evaluative, not a mere case listing
- —Submission cadence set by regulation and product risk
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report; EU pharmacovigilance legislation PSUR provisions (Directive 2001/83/EC; Regulation (EC) No 726/2004).
Frequently asked questions
What does PSUR / PBRER stand for?
PSUR / PBRER stands for Periodic Safety Update Report / Periodic Benefit-Risk Evaluation Report.
What is PSUR / PBRER?
A PSUR (in EU terminology) — structured on the ICH E2C(R2) PBRER format — is a periodic, cumulative post-authorization report evaluating the benefit-risk balance of a medicinal product using worldwide safety and, where relevant, efficacy data over a defined interval. Its purpose is not merely to list cases but to present an integrated benefit-risk assessment and to identify whether any new information changes the product's established profile. Submission frequency is set by regulation and by the product's risk.
Which regulations cover PSUR / PBRER?
ICH E2C(R2) Periodic Benefit-Risk Evaluation Report; EU pharmacovigilance legislation PSUR provisions (Directive 2001/83/EC; Regulation (EC) No 726/2004).