Readability test for package leaflets — validated and recognized by authorities
A readability test (also: Readability User Test) uses one-on-one interviews to verify whether patients can correctly understand and safely use a package leaflet. It is required by EU law for the marketing authorization of medicinal products and is a mandatory component of CTD Module 1.3.4. Beate Beime Pharma Consulting has been conducting validated readability tests since 2005 using the standardized interview method validated by Dr. Beate Beime — recognized by all European regulatory authorities, including the EMA.
Regulatory Background
What is a readability test?
EU Directive 2001/83/EC stipulates that the package insert for a medicinal product must be understandable and legible to patients. This is verified through a readability test in which 20 participants from the medicinal product ’s target audience are interviewed in standardized one-on-one interviews. The test assesses whether they can identify, understand, and correctly apply the document’s key messages.
The test is not a reading comprehension or language test — it measures the usability of a regulatory document under real-world conditions. A passed readability test serves as proof to regulatory authorities that the package leaflet is understandable, making it a critical document in the marketing authorization process.
Scope of Services
Our Readability Testing Services
Package Insert / Instructions for Use (IFU) for medicinal product
The standard readability user test for package leaflets: 20 individual interviews with native speakers from the target group, direct evaluation after each interview, identification of unclear passages, and the opportunity for immediate revision. Final report in English for CTD Module 1.3.4 — delivered within four weeks of receiving the final mock-up. Conducted in German and English with certified native speakers.
Bridging Report and Focus Test
If a package leaflet is already based on a readability-tested template or if only minor text modifications have been made, a bridging report or a reduced focus test may be conducted instead of a full readability test, subject to certain conditions. We assess whether your document meets the requirements for a bridging report or focus test and guide you through the streamlined procedure.
Lay Summary / Clinical Documents
Lay summaries of clinical trials in accordance with EU Regulation 536/2014 must be easily understandable for the general public. We conduct readability tests for lay summaries and other patient or educational materials.
Our Process
Our Process: From Mock-up to Final Report
Receipt of the Final Mock-up
You send us the final mock-up of your package leaflet or instructions for use. We review it for suitability for the readability test and clarify any open questions during an initial consultation. If required, we can create a mock-up based on your text template.
Participant Recruitment
We will recruit 20 participants from the defined target group of your medicinal product —a representative sample based on age, gender, and educational background.
Individual Interviews with Direct Evaluation
Every interview is conducted in accordance with our validated and audited procedure. An immediate evaluation follows each interview, allowing incomprehensible passages to be identified instantly and revised during the testing phase if necessary.
Final Report / CTD Module 1.3.4
You will receive a comprehensive final report in English, prepared for submission in CTD Module 1.3.4.
Expertise and Quality
Why pharmaceutical companies trust our method
Validated and audited testing procedure
The interview method validated by Dr. Beate Beime is standardized and meets the requirements of all European regulatory authorities.
Recognized by authorities since 2005
We have been conducting readability tests since the inception of EU legislation and are familiar with the requirements of the EMA and all national authorities.
Immediate evaluation after each interview
No waiting until the end: issues become apparent immediately, enabling rapid corrections and minimizing the need for re-testing rounds.
Conducted in German and English
With native speakers, for international regulatory procedures.
25+ years of experience
In " marketing authorisation " and clinical studies.
Expert lectures and conferences
- DGRA Workshop "Product Information and Labelling", Bonn 2019 — Readability Tests and Alternatives
- ExpertFORUM Labelling "Product Information and Safe Labelling", Düsseldorf 2016
- Forum Institut: "Scientific Writing and Reviewing in Regulatory Affairs", Frankfurt 2017 & Cologne 2018
Team
Your contact persons
Readability User Testing
Developer of the validated interview method for readability testing. Consultant for marketing authorisation and clinical trials. Has been conducting readability tests and providing consulting services for the European pharmaceutical industry since 2005.
Readability User Testing
Extensive experience in the planning, implementation, and evaluation of readability tests for medicinal product and medical devices.
Readability User Testing
Master of Drug Regulatory Affairs with extensive experience in project management and the evaluation of readability tests.
FAQ
Frequently Asked Questions about Readability Tests
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Under EU Directive 2001/83/EC, a readability test is mandatory for all medicinal product applying for marketing authorization in the European Union. The test must be conducted upon submission of the marketing authorization application and is submitted as part of CTD Module 1.3.4. A new readability test may also be required in the event of substantial changes to an existing package insert.
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A comprehensive readability test consists of 20 individual interviews with participants from the target audience of medicinal product. This number is in line with EMA recommendations and is specified in the Guideline on the Readability of the Labeling and Package Leaflet of Medicinal Products for Human Use. Participants are selected to be representative in terms of age, gender, and educational background.
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Typically, we can complete the full readability test, including the final report, within four weeks of receiving the final mock-up. This rapid turnaround is possible because we perform a direct evaluation after each interview, allowing for immediate adjustments if necessary.
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A full readability test involves 20 individual interviews and is conducted for new package leaflets or following major text revisions. A bridging report is a streamlined alternative that can be used if your package leaflet is based on a template that has already undergone readability testing or if only minor text modifications have been made. We advise you on which approach is suitable for your document.
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We conduct readability tests in German and English with certified native speakers. The final report is standardly prepared in English, as required for international submission to European authorities. Please contact us regarding additional languages.
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CTD Module 1.3.4 (Consultation with Target Patient Groups) includes the submission of the complete readability test report, the tested mock-up of the package leaflet, and a summary of the test results and implemented revisions. We prepare all required documentation for your submission.
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Under EU Regulation 536/2014 (Clinical Trials Regulation), a readability test for lay summaries is recommended by the EU Expert Group on Clinical Trials and is considered good practice. While not formally mandatory, it is expected by the authorities and requires robust justification if omitted. We support you in the creation and readability testing of lay summaries.
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Request a Readability Test Now
Get in touch with us — we provide free, non-binding advice on which type of readability test is appropriate for your document and what the process entails.
Beate Beime Pharma Consulting
Damm 37 · 26135 Oldenburg
Tel.: +49-441-9251780
E-Mail: info@beatebeime.de