PSUR / PBRER Checklist
Prepare a Periodic Safety Update Report / Periodic Benefit-Risk Evaluation Report per ICH E2C(R2). Track every required section - progress auto-saves locally.
PSUR Progress
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About this checklist
This checklist follows the ICH E2C(R2) structure for Periodic Benefit-Risk Evaluation Reports (PBRERs). PPB accepts PBRER-format PSURs for products registered in Kenya. Reporting frequency depends on the MAH approval conditions - typically 6-monthly for the first 2 years, annually for years 3-5, then 3-yearly thereafter.
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Get PV SupportWhat is a PSUR / PBRER and Why It Matters
A Periodic Safety Update Report (PSUR) is a structured pharmacovigilance document that a Marketing Authorisation Holder (MAH) submits to regulators at defined intervals to summarise the worldwide safety experience of a medicinal product. Under ICH E2C(R2), the modern format is the Periodic Benefit-Risk Evaluation Report (PBRER), which keeps the safety analysis but adds a formal evaluation of benefit against risk. The goal is to confirm that the product's benefit-risk balance remains favourable in the populations and indications for which it is authorised.
A PSUR is not a simple list of adverse events. It pulls together cumulative and interval data on exposure, individual case safety reports (ICSRs), signals, literature, completed and ongoing studies, and any regulatory or MAH-initiated actions taken for safety reasons. From that evidence the report draws a single conclusion: whether the reference safety information (the SmPC or company core data sheet) still reflects the known risks, or whether label changes, new studies, or risk minimisation measures are needed.
In Kenya, the Pharmacy and Poisons Board (PPB) requires periodic safety reporting as a condition of marketing authorisation and accepts PBRER-format PSURs aligned with ICH E2C(R2). For local MAHs and Local Technical Representatives acting on behalf of foreign manufacturers, a complete, well-structured PSUR is the main way to demonstrate ongoing pharmacovigilance compliance and to keep a product registration in good standing. A missing or incomplete section is a common cause of queries and delays, which is exactly what this checklist helps you avoid.
How to Use This PSUR Checklist
Work Through Each Section
The checklist mirrors the ICH E2C(R2) structure, from the introduction and worldwide authorisation status through signal evaluation to the integrated benefit-risk analysis and appendices.
Tick Off Completed Items
Check each item once that content is drafted and verified in your report. Your progress saves automatically in your browser, so you can return later without losing your place.
Track Your Progress
The progress bar shows how complete your PSUR is across all sections. Aim for 100 percent before you finalise the data lock point version for review.
Print or Save as PDF
Use Print / Save PDF to keep a dated record of the completed checklist for your quality and pharmacovigilance files, or to hand off to a reviewer or QPPV.
Frequently Asked Questions
About PSURs, PBRERs, and this checklist