Readability Test for Package Inserts — Validated and Approved by Regulatory Authorities
A readability test (also known as a readability user test) uses individual interviews to determine whether patients can correctly understand a package insert and use the medication safely. It is required under EU law for the approval of medicinal products and is a mandatory component of CTD Module 1.3.4. Since 2005, Beate Beime Pharma Consulting has been conducting validated readability tests using the standardized interview method validated by Dr. Beate Beime—a method 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 medication’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 or language comprehension test—it measures the usability of a regulatory document under real-world conditions. Passing a readability test serves as proof of the package insert’s comprehensibility to the regulatory authorities and is therefore a key document in the approval process.
Scope of Services
Our Performance in the Readability Test
Package Insert / Instructions for Use (IFU) for Medications
The classic Readability User Test for package inserts: 20 individual interviews with native speakers from the target audience, immediate evaluation after each interview, identification of unclear passages, and the opportunity for immediate revisions. 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 insert is already based on a template that has undergone a readability test, or if only minor text adjustments have been made, a bridging report or a reduced focus test may be conducted in place of a full readability test under certain conditions. We will determine whether your document meets the requirements for a bridging report or focus test and guide you through the simplified process.
Lay Summary / Clinical Documents
Clinical trial summaries for laypeople (Lay Summaries) prepared in accordance with EU Regulation 536/2014 must be understandable to the general public. We conduct readability tests for Lay Summaries and other patient and 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 insert or user manual. We review it to ensure it’s suitable for the readability test and address any outstanding questions during a preliminary discussion. If necessary, we’ll create a mock-up for you based on your text draft.
Recruitment of Participants
We will recruit 20 participants from the defined target group for your drug—a representative sample based on age, gender, and educational background.
One-on-one interviews with immediate evaluation
Every interview is conducted according to our validated and audited procedure. Each interview is evaluated immediately afterward, so that any unclear passages can be identified right away and revised, if necessary, even during the testing phase.
Final Report/CTD Module 1.3.4
You will receive a complete final report in English, formatted 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.
Officially recognized 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 need to wait until the end: Problems become apparent immediately, allowing for quick corrections and minimizing the number of retest rounds.
Conducted in German and English
With native speakers, for international admissions processes.
25+ years of experience
In drug approval and clinical trials.
Specialized Presentations and Conferences
- DGRA Workshop “Product Information and Labeling,” Bonn 2019 — Readability Tests and Alternatives
- ExpertFORUM Labeling: “Product Information and Safe Labeling,” Düsseldorf 2016
- Forum Institute: “Scientific Writing and Reviewing in Regulatory Affairs,” Frankfurt 2017 & Cologne 2018
Team
Your Contacts
Readability User Testing
Developer of the validated interview method for readability testing. Consultant for drug approval and clinical trials. Has been conducting readability tests and providing related consulting services for the European pharmaceutical industry since 2005.
Readability User Testing
Extensive experience in the planning, implementation, and evaluation of readability tests for pharmaceuticals and medical devices.
Readability User Testing
Master's degree in Drug Regulatory Affairs with many years of experience in project management and the evaluation of readability tests.
FAQ
Frequently Asked Questions About the Readability Test
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Under EU Directive 2001/83/EC, a readability test is mandatory for all medicinal products seeking 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 drug’s target population. This number is in line with EMA recommendations and is specified in the Guideline on the Readability of the Labeling and Package Insert of Medicinal Products for Human Use. Participants are selected to be representative in terms of age, gender, and educational background.
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We are generally able to complete the full readability test, including the final report, within four weeks of receiving the final mockup. This short turnaround time is possible because we conduct an immediate evaluation after each interview and allow for immediate corrections as needed.
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A comprehensive readability test consists of 20 individual interviews and is conducted for new package inserts or following significant text changes. A bridging report is a simplified version that can be used if your package insert is based on a template that has already undergone readability testing or if only minor text adjustments have been made. We will advise you on which option is best suited for your document.
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We conduct readability tests in German and English with certified native speakers. The final report is prepared in English by default, as required for international submissions to European authorities. Please contact us regarding other languages.
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For CTD Module 1.3.4 (Consultation with Target Patient Groups), the submission includes, among other things, the complete readability test report, the tested mock-up of the package insert, and a summary of the test results and revisions made. We will prepare all the necessary documents for you for submission.
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According to 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. Although it is not formally mandatory, it is expected by regulatory authorities, and a well-reasoned explanation should be provided if it is not conducted. We can assist you with the preparation and readability testing of lay summaries.
Contact Form
Request a readability test now
Contact us—we’ll advise you, free of charge and with no obligation, on which type of readability test is suitable for your document and what the process entails.
Beate Beime Pharma Consulting
Damm 37 · 26135 Oldenburg
Tel.: +49-441-9251780
Email: info@beatebeime.de