Missed PSUR deadlines and poor-quality periodic safety reports are among the most common findings in pharmacovigilance inspections. Jeyflex provides end-to-end Periodic Safety Report management covering PSURs, PBRERs, and DSURs, ensuring your safety reports are accurate, compliant, and submitted on time across every African market you operate in.
PSUR, PBRER & DSUR Management Across Africa
Is Your Next PSUR Deadline on Track?
What are Periodic Safety Reports?
Periodic Safety Reports are regulatory submissions that compile and evaluate cumulative safety data for a medicinal product over a defined period. They are a core pharmacovigilance obligation — required by regulatory authorities globally and increasingly by African national regulatory authorities — providing a comprehensive benefit-risk assessment of your product throughout its lifecycle.
There are three main types of periodic safety reports:
Jeyflex manages the full PSUR lifecycle from data collection and analysis through to final submission, so your deadlines are never at risk.
Our Step-by-Step PSUR Management Process
Every periodic safety report is managed through a structured, audit-ready workflow — aligned with ICH E2C(R2), GVP Module VII, and the specific submission requirements of each target regulatory authority.
01
PSUR Planning & Timeline Management
We establish a clear PSUR schedule for your product portfolio — mapping all submission deadlines across each African market and international authority, with built-in timelines for data collection, drafting, review, and final submission.
02
Data Collection & Cumulative Analysis
We compile all cumulative safety data for the reporting period — including ICSRs, literature findings, clinical study data, and regulatory authority communications — and perform a thorough analysis of the overall safety profile.
03
Benefit-Risk Evaluation
Our medical experts perform a rigorous, evidence-based benefit-risk evaluation for the reporting period — assessing whether the product’s benefits continue to outweigh its risks in light of all cumulative safety data collected.
04
Report Authoring & Quality Review
We author the complete PSUR or PBRER in the required format — ICH E2C(R2) structure for international submissions or the specific format required by the target African regulatory authority — followed by a thorough quality review before client sign-off.
05
Regulatory Submission & Follow-Up
We manage the formal submission of your PSUR or PBRER to the relevant regulatory authority within the required deadline — and follow up on any queries or requests for additional information from the authority.
06
Archive & Next Cycle Preparation
The completed report is archived in an inspection-ready format and the next reporting cycle is immediately planned — ensuring continuity, no gaps, and no last-minute deadline pressure in the next period.
PSUR, PBRER and DSUR - What is the Difference?
While these three report types all fall under the periodic safety reporting umbrella, they serve different purposes and are submitted to different audiences at different stages of a product’s lifecycle.
Jeyflex manages all three report types — so your entire periodic safety reporting programme is covered under one expert team.
Why Choose Jeyflex for Periodic Safety Report Management?
Our Periodic Safety Reporting Services
A complete suite of periodic safety reporting services covering every stage of the PSUR, PBRER, and DSUR lifecycle.
The Cost of a Missed PSUR Deadline
A missed PSUR deadline is not just a procedural issue — it is a pharmacovigilance compliance failure with direct regulatory consequences:
Timely, accurate PSUR submission is a non-negotiable regulatory obligation, not an optional compliance activity.
Frequently Asked Questions
A PSUR (Periodic Safety Update Report) is the traditional format for periodic safety reporting, while a PBRER (Periodic Benefit-Risk Evaluation Report) is the internationally harmonised format developed under ICH E2C(R2). The PBRER is now accepted by most regulatory authorities globally, including the EMA, WHO, and a growing number of African NRAs, as the standard format for periodic safety submissions. In practice the two terms are often used interchangeably. Jeyflex authors reports in whichever format is required by the specific regulatory authority.
PSUR submission frequency depends on the product’s approval status and the regulatory authority’s requirements. Common intervals are every 6 months for the first two years post-approval, annually for the following three years, and every three years thereafter — though this varies by market and product risk profile. Jeyflex manages your full submission calendar to ensure all deadlines are tracked and met across every African market where your product is registered.
Yes. An increasing number of African national regulatory authorities — including Kenya’s PPB, Uganda’s NDA, Ethiopia’s EFDA, Rwanda’s RFDA, Tanzania’s TMDA, Nigeria’s NAFDAC, and South Africa’s SAHPRA — require periodic safety reports as part of post-marketing pharmacovigilance obligations. Requirements vary by country and product type. Jeyflex advises on the specific PSUR requirements for each target market and manages submissions accordingly.
Yes. This is one of Jeyflex’s core strengths — managing PSUR and PBRER submissions across multiple African markets under a single, coordinated programme. Rather than managing separate timelines and separate submissions for each country, Jeyflex consolidates the process and provides a single point of accountability for your entire periodic safety reporting portfolio.
Yes. We have experience helping organisations bring overdue PSUR programmes back into compliance — starting with a rapid assessment of the backlog, prioritising the most urgent submissions by regulatory risk, and working through a structured remediation plan. Contact us to discuss your situation and we will provide a clear plan for getting your PSUR programme back on track.
Never Miss a PSUR Deadline Again
Whether you need a single PSUR authored, a full portfolio managed across multiple African markets, or help catching up on overdue submissions, Jeyflex is ready to help. Speak with our team today.