User Testing: The EMEA Experience

Introduced by the revised pharmaceutical legislation in November 2005, consulting target patient groups ("user testing") aims to improve the information provided in the package leaflet (PL) and make it more suitable to patients' and caregivers' needs. EMEA analysed the first year of experience with user testing by reviewing report assessments submitted by the pharmaceutical industry to identify areas where different views have been expressed. These results were shared and discussed with the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMD(h)) with the objective of harmonising the approach to user testing at the European level. Preliminary results regarding compliance and final outcome are encouraging. However, one of the main conclusions of the exercise is the need for further guidance for both industry and assessors.