When patients misunderstand medicine instructions, the consequences can be serious. That’s why regulators in the EU and EAEU require Readability User Testing (RUT) to ensure patients can find and understand the information they need, before mistakes happen. RUT is a practical step to protect patient safety and ensure compliance.
When do you need Readability User Testing?
A full readability user test is typically required when:
- You’re submitting a new marketing authorization in the EU or EAEU. This also applies to line extensions, such as a new strength or pharmaceutical form.
- Your PIL has undergone significant changes, whether in the text itself or the mock-up, such as safety variations, new indications, or the inclusion of a new patient group.
- You switched your Rx medicinal product to OTC
Alternatively, if your leaflet closely resembles a previously tested and approved version, either your own or from a similar medicinal product, a Bridging Report or Focus Testing may be sufficient. This faster and more cost-effective approach still ensures compliance without duplicating work.
What does the process look like?
Step 1: Initial Assessment
We assess your package leaflet’s language, layout, structure, and terminology to identify areas that might confuse patients.
Step 2: Interviewing
We conduct structured interviews with potential users to assess how easily they can find and understand key safety information and use instructions.
Step 3: Analysis and Reporting
We analyze the results, propose improvements, and prepare a report ready for submission.
Why work with Biomapas?
At Biomapas, we help you make the smartest choice for your portfolio. Whether you’re managing multiple products or a single submission, our team will help you define the most efficient strategy, balancing full RUTs and Bridging Reports to save time and cost. What sets us apart:
- Strategic support across your full portfolio, not just one leaflet at a time.
- Expertise in both EU and EAEU regulatory environments.
- Deep experience with interviews, analysis, and reporting, handled by qualified medical writers and regulatory professionals.
- Hands-on pre-testing assessments to increase the likelihood of first-time approval.
We also provide pre-testing assessments to improve your chances of success, refine the structure, simplify language, and flag any problem areas before formal testing begins.
Your next step
Contact us today to find out if your leaflet qualifies for a bridging approach, if a full RUT is required, and how we can help make the process smooth, compliant, and patient-focused.
