What is it about?
Package leaflets of medicines distributed within the European Union should use the template headings and standard texts created by the Working Group on the Quality Review of Documents (QRD). The following study investigated how the QRD template is implemented in this patient information.
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Why is it important?
QRD template texts are used in all package leaflets of the European Union; however, these texts are responsible for more than 20% of package leaflets' word count. To keep package leaflets concise, the current QRD template should be significantly shortened, which would improve all package leaflets in each EU country where the template is implicated.
Perspectives
The pharmaceutical industry and EU authorities should pay more attention to only using the essential template parts. To keep EU package leaflets concise, the current QRD template should be significantly shortened, which would improve all package leaflets in each EU country.
Dr Jörg Fuchs
PAINT-Consult
Read the Original
This page is a summary of: Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicines, Therapeutic Innovation & Regulatory Science, December 2015, SAGE Publications,
DOI: 10.1177/2168479015620247.
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