Objectives: To document the extent to which treatment satisfaction evidence is provided in support of EMEA regulatory approvals and to evaluate the quality of evidence provided in support of treatment satisfaction claims.Methods: A review of EMEA published reports for all drugs approved since a centralised process was established in 1995 was undertaken: specifically the Scientific Discussion/Public Assessment Reports were reviewed for evaluations of patient-reported treatment satisfaction.  The wording and types of PROs contained within approved product labels were examined in order to establish the nature and extent of previous successful claims for treatment satisfaction.Results: A total of 508 currently authorised medicinal product approvals were reviewed, 26 made reference to ‘satisfaction’ or ‘satisfied’ but 9 were excluded for not focusing on patient-reported treatment satisfaction thus 17 medicinal products were identified as having a direct reference to evaluating patient-reported treatment satisfaction.  These 17 approvals ranged from July 1998 to July 2008, and were distributed across a broad range of pharmaco-therapeutic groups with a cluster of approvals for ‘insulin analogues for injection, long lasting’ (n=4): 10/17 approvals provided limited reference to the way in which treatment satisfaction was evaluated e.g. reference to a total satisfaction score without any further details, 2/17 measured treatment satisfaction using a VAS; 5/17 referenced a specific treatment satisfaction measure.  5/17 provided treatment satisfaction of results, yet only two of these gave any details on the way in which treatment satisfaction was measured. Conclusion: Treatment satisfaction data has been used in a limited way to support EMEA drug approvals but the value of this data in support of product approvals has not been fully achieved.  It is recommended that treatment satisfaction data be collected using carefully developed and validated patient-reported questionnaires, with greater attention to instrument description and data reporting in approval documents.