On 30 October 2005, the user testing of Patient Information Leaflets (PILs) became mandatory across the European Union.

PILs are an integral part of the Marketing Authorization (MA) of a medicinal product. They are important for the safe use of the medicine and are the “public face” of the Summary of Product Characteristics (SmPC) and the MAH themselves.

All medicines are required by law to be accompanied by comprehensive information. Although this is intended to supplement the information provided by the healthcare professional, the information must be accessible and understandable to those who receive it. This ensures that medicines can be used both safely and appropriately. So, as well as being a legal obligation of MAH, the user testing of PILs can be a crucial process to guarantee that the message contained in the PILs is clear and understandable to the patient.

The legal basis of user testing lies in Title V of Council Directive 2001/83/EC. Article 59(3) notes that the PIL shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. In addition, Article 61(1) requires that the MAH submits results of such user tests to the competent authority for consideration as part of the approval of the PIL.

User testing was first proposed in the early 1990s in Australia. It is based on the performance of the PIL and relies on outcomes which will identify barriers to peoples' ability to use the information presented in the PIL. User testing is a tool which is flexible and aims to identify whether or not the information, as presented, conveys the correct message to those who read it. Testing itself does not improve the quality of the information but will indicate where there are problem areas which should be rectified. This is particularly powerful when used as part of an iterative leaflet development process.

The term 'user testing' was first adopted by the EU in 1999 in the Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use. This guidance proposes a particular method of diagnostic testing of PILs, but recognizes that other performance-based methods may be valid and the MHRA have indicated that they would be willing to judge these methods, on a case-by-case basis.
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