REPORTREFERENCE OUTLINE

Periodic Benefit-Risk Evaluation Report (PBRER)

Periodic re-examination of whether a product’s benefits still outweigh its risks: data lock point and interval, regulatory and study developments, interval and cumulative datasets, signal evaluation with conclusions attached, and an integrated benefit-risk analysis naming the population it applies to. Maps to ICH E2C(R2).

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH E2C(R2)
DOCUMENT TYPE
Report
LAST UPDATED
August 2026
PURPOSE

A periodic re-examination of whether a product’s benefits still outweigh its risks in light of everything learned since approval. The report is judged on its reasoning, not its length: the common failure is a data dump of line listings and tabulations with no evaluation attached to any of them. Whether the balance remains favourable, and for which population, is the marketing authorisation holder’s conclusion to reach and defend.

What's Inside

✓Report identification with the international birth date, the data lock point and the interval covered
✓Regulatory and study developments in the interval, including actions taken by any authority for safety reasons
✓Exposure estimates with the estimation method stated, so intervals can be compared rather than merely reported
✓Interval and cumulative datasets presented by source, with the boundary between the two left unambiguous
✓Signal evaluation carrying a conclusion and an action for each signal, rather than a listing alone
✓Integrated benefit-risk analysis that names the population and indication the conclusion applies to
✓Conclusions and actions with owners and due dates, and the approval that closes the report

How to Use It

1Fix the data lock point before assembling anything — moving it mid-preparation invalidates every tabulation already produced and restarts the work.
2State the exposure estimation method; a denominator without a method cannot be compared across intervals, and that comparison is most of the value here.
3Keep the interval and cumulative datasets visibly separate, because a reader who cannot tell them apart cannot judge the trend.
4Attach an evaluation and an action to every signal — a listing with no reasoning is what this report is most often criticised for.
5Name the population the benefit-risk conclusion applies to, rather than stating a balance for the product in general.
6Append line listings and tabulations rather than reproducing them in the body, so the body carries the argument alone.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Report Identification and Interval
2Regulatory and Study Developments in the Interval
3Data Presented
4Signal and Risk Evaluation
5Benefit-Risk Evaluation
› Benefit in the approved indications› Integrated benefit-risk analysis
6Conclusions and Actions
REGULATORY CONTEXT

ICH E2C(R2) defines the Periodic Benefit-Risk Evaluation Report — its interval and data lock point conventions, the developments and datasets it must present, and the integrated benefit-risk evaluation it must reach. It does not decide whether your product’s balance remains favourable, which signals warrant action, or how exposure should be estimated for your product and its markets. Those are the marketing authorisation holder’s determinations. The section guidance and sequencing here are SPEQ practitioner synthesis.

MAPPED STANDARDS
ICH E2C(R2)
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