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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The checklist and progress tracking are free. Generating and printing the finished PSUR is a one-time unlock of USD 15 for your account. Sign in to unlock.
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.
Related pharmacovigilance tools: complete a structured ADR report for the individual case safety reports that feed your tabulations, score suspected reactions with the Naranjo ADR causality calculator, or see our full pharmacovigilance services.
PSUR Writing: How This Tool Helps You Write a PBRER
PSUR writing is easier when the report is planned around a fixed structure before you draft a single paragraph. This page works as a PBRER writing tool in two stages. First, the free checklist and progress tracker lay out every ICH E2C(R2) section in the exact order a reviewer expects, so you always know what to write next and what remains outstanding at the data lock point. Second, our paid PSUR generation feature turns that completed structure into the finished report, ready for pharmacovigilance review.
If you are learning how to write a PBRER, the quickest way to avoid queries is to follow the ICH E2C(R2) running order rather than inventing your own. The steps below map the checklist sections to the writing task at each stage, so you can write a PSUR section by section without losing the thread of the benefit-risk argument.
1. Set the frame
Write the introduction, worldwide authorisation status, and reference safety information sections first. These fix the product, the data lock point, the reporting interval, and the SmPC or company core data sheet that the rest of the report is measured against.
2. Lay out the data
Draft the exposure estimates, summary tabulations of individual case safety reports, and the summaries of significant findings from studies and literature. This is the factual evidence base every conclusion later in the PSUR has to rest on.
3. Evaluate the evidence
Write the signal and risk evaluation and the benefit evaluation. Characterise each risk by frequency, severity, and reversibility, and record the effectiveness of any risk minimisation measures already in place.
4. Reach the conclusion
Finish with the integrated benefit-risk analysis, conclusions and actions, and appendices. State plainly whether the benefit-risk balance stays favourable and whether the reference safety information needs to change.
Once every section is drafted and ticked off, our PSUR generation feature produces the finished PBRER document from your completed structure. Signed-in accounts can unlock it with the Generate PSUR button at the top of the page. The checklist and progress tracking stay free; only generating and printing the completed report is a one-time paid unlock. For MAHs that would rather hand the whole job over, our team can write a PSUR or PBRER for you end to end through our pharmacovigilance service.
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