PSUR and PBRER: Periodic Safety Reporting Without the Confusion

The two terms are used interchangeably but are not quite the same thing.

PBRER is the Periodic Benefit-Risk Evaluation Report, the format defined by ICH E2C(R2).

PSUR is the Periodic Safety Update Report, which is what EU legislation calls the report a marketing authorization holder must submit. Since E2C(R2), the EU PSUR is submitted in the PBRER format.

In conversation people say PSUR and mean both.

Purpose

It is a periodic reassessment of whether the benefit-risk balance of a marketed product still holds, in light of everything learned since the last one.

This framing is what R2 changed. The earlier PSUR was safety-focused and reported what happened. The PBRER asks whether, given what happened, the product is still worth using and whether anything needs to change.

Birth date and data lock point

International Birth Date (IBD). The date of the first marketing authorization for the product anywhere in the world. Reporting periodicity is anchored to it, which means a product first approved in a small market carries that date globally.

Data Lock Point (DLP). The cut-off date for data included in the report. Everything up to the DLP is in scope; everything after waits for the next one.

Submission is due within a set period after the DLP: 70 days for reporting intervals of 12 months or less, 90 days for longer intervals.

The DLP cannot be moved. Work backwards from it, because line listings, signal evaluation and the benefit-risk discussion all have to happen inside a fixed window after the data closes.

Contents

Beyond the safety data:

• Estimated exposure, from sales or prescription data. A rate needs a denominator.
• Summaries of significant findings from clinical trials, non-interventional studies, and the literature during the interval.
• Signal evaluation: signals identified, evaluated, and their outcomes, which connects directly to signal detection practice.
• Benefit evaluation and an integrated benefit-risk analysis.
• Actions taken for safety reasons, and changes to the reference product information.

Common failures

The schedule is missed because periodicity changed. The EU publishes the EURD list, which sets DLPs and frequencies for substances, and it overrides what the authorization originally said. A holder still working from the original schedule is late without knowing.

The report contradicts the label. A PBRER describing a risk the CCDS does not reflect raises the obvious question of why the label was not updated.

Exposure data is soft. Benefit-risk is a rate argument, and a weak denominator undermines it.