PIL Readability Testing & Bridging Reports

Under Articles 59(3) and 61(1) of Directive 2001/83/EC, package leaflets must reflect consultation with target patient groups. This demonstrates that patients can use the information. Supporting evidence is included in CTD/eCTD Module 1.3.4, where applicable.

Evidence of patient consultation is generally needed for new marketing authorisation applications and relevant changes to existing leaflets. The appropriate approach depends on the product and procedure; a separate full test is not always necessary.

No. Existing consultation evidence may support a new leaflet through a justified bridging assessment. Other consultation methods can also be acceptable. The approach must suit the product and be supported by adequate evidence.

A bridging report compares a proposed "daughter" leaflet with one or more successfully tested "parent" leaflets. It explains whether similarities in content, layout, writing style and important safety messages justify relying on existing test results.

We compare both leaflets, their intended users, key safety messages, layout and wording. The reference leaflet must have suitable evidence from successful user testing. We assess whether any differences require additional testing or a different approach.

Our standard approach involves 20 participants, usually in two rounds of 10, with a pilot where appropriate. Participants are asked to find information, explain its meaning and show how they would act on it.

We analyse where participants struggled and recommend changes to the wording, structure or design. The revised leaflet can then be tested again where necessary. An expert review before testing helps identify potential problems early.

Final acceptance rests with the competent authority. To date, all our reports submitted for regulatory assessment have been accepted. Where necessary, we promptly clarify any questions raised by the authority, in coordination with the applicant.

For a full test, we provide a protocol, questionnaire, results, recommendations and a final readability report. For bridging, we prepare a comparative justification. Relevant documentation can support CTD/eCTD Module 1.3.4, depending on the procedure.

Yes. We adapt studies to the medicine, target population and regulatory context. Expert review, packaging assessment, eye-tracking or additional user research may be added where useful, separately from the core regulatory consultation evidence.

Please send us the leaflet text in Word (.docx), the proposed leaflet artwork and the Summary of Product Characteristics (SmPC). We normally sign an NDA and a service agreement or purchase order, depending on the cooperation model. For established clients, an email order is sufficient.

Yes. We usually work with print-ready artwork provided by our clients. If needed, our in-house design studio can prepare the leaflet from a Word document, following established readability and layout principles and any applicable printing specifications.