OBJECTIVES: The PROLabels database (www.mapi-prolabels.org) is a unique online tool collecting information on the medical and biological products for which the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted a Patient-Reported Outcome (PRO) labeling claim. The purpose of this abstract is to present an overview of the database six years after its implementation in April 2006. METHODS: To create the database, data were retrieved on the EMA website, from the European Public Assessment Reports for all the drugs approved through a centralized procedure since 1995. Evidence of a PRO endpoint was pulled for each product from the Summary of Product Characteristics and, when necessary, additional information was gathered from the scientific discussions. From the FDA website, data were collected from the approved labels and additional information was retrieved in the Medical Reviews. The database now contains all drugs approved or revised by the FDA since 1995, including Biological Approvals (BLAs). For the purpose of this review, all approvals between 1995 and 2011 were reviewed individually for each agency.  RESULTS: As of December 31, 2011, the database contains 486 records of which 342 products were approved by the FDA (22.6% of all FDA approvals). There were 144 products with a PRO claim approved by the EMA (24.2% of all EMA approvals). Nervous system diseases is the therapeutic area for which the highest number of products is approved with a PRO claim (n=153), followed by the immune system diseases (n=105). Signs and symptoms are the most frequently measured PROs while health-related quality-of-life represents only 16.9% of all drugs approved with a PRO claim.  CONCLUSIONS: The PROLabels database provides easy access to information regarding PRO claims in approved labels for both FDA and EMA in one location and information about PRO claims trends in the USA and Europe.