OBJECTIVES: Our objective was to compare the PRO endpoints recommended by the EMEA note for guidance on the clinical investigation of medicinal products indicated for the treatment of psoriasis (CHMP/EWP/2454/02) published in November 2004, with those used for the approval of medicinal products for psoriasis. METHODS: The EMEA website was searched to identify all medicinal products approved specifically for psoriasis since 1995. PROlabels was searched to identify the products with a PRO labeling claim. RESULTS: The EMEA guidance specifies that “Patient-assessed drug efficacy may be a secondary or tertiary endpoint in pivotal clinical trials. These measures correspond both to efficacy evaluated by patients and to health-related quality of life (HRQL) scales validated in dermatology”. The guidance quotes simple measures such as symptom improvement, tolerability, cosmetic acceptability, ease of use, patient’s assessment of global improvement and more complex measures, such as the patient’s assessment of PASI, the Dermatology Life Quality Index (DLQI), Dermatology Quality Life Scales (DQOLS), Skindex, Psoriasis Disability Index (PDI), and Psoriasis Life Stress Inventory (PLSI). Three products were retrieved; two approved before the publication of the guidance (2003, 2004) and one after (2009). Methotrexate, cyclosporine and corticoids were not included for their lack of specificity. All three products had a PRO labeling claim. Improvement in the DLQI was used as a secondary endpoint in all products and quoted on the label. Itch was measured for 2 products (2004, 2009) by patient’s symptom measures and included on the label. Two products (2003, 2009) used the SF-36. CONCLUSIONS: There is a close adherence to the guidance concerning the choice of PRO endpoints. However, comparison of the dates of the guidance publication and of the products’ approval suggest that the guidance has only endorsed an existing practice in the choice of study endpoints for the evaluation of medicines indicated for psoriasis.