OBJECTIVES:  To document patterns in EMEA and FDA approved product label claims based on patient self-report data before and after publication of the 2005 EMEA Reflection Paper on Health-related Quality of Life (HRQL) and FDA’s draft guidance on Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.    METHODS: PRO claims for products approved between January 2000 and June 2008 were identified from review of the PROQOLID database.  Analyses compared FDA and EMEA claims for the same product to document patterns in the number and types of claims approved, and to determine whether the nature of claims reflect recent FDA and EMEA guidance on review of PRO and HRQL data. RESULTS: More PRO-based claims were approved by FDA than EMEA (147 vs. 77) during the 9 year period.  Of these, only 27 were for the same product reviewed and approved by both agency.  PRO-based claims usually involved symptoms (FDA=127, 86%; EMEA=53, 69%).  EMEA approved more claims for improvement in HRQL than did FDA (EMEA=31; FDA=11).  Nine of 31 (29%) of EMEA approved HRQL claims were granted since the publication of the EMEA Reflection paper; compared with 45% (5 of 11) of FDA-approved HRQL claims granted since the draft FDA PRO guidance was issued.    CONCLUSIONS:  Despite concerns that PRO and HRQL claims would be less common after issuance of these guidance documents, approvals to date suggests that PRO continue to be critical for symptom claims and HRQL claims continue to be granted by both agencies.  Clinician-reported symptom assessments may explain some differences in symptom claims.