OBJECTIVES: Public health policies rely largely on observational studies developed through the compilation of real world data. From the access and health technology assessment (HTA) perspectives, real world data are an essential ancillary tool in decision-making, providing information on burden of disease, cost-of-illness, resource usage, treatment patterns, compliance, natural history of the disease, effectiveness and safety. The Brazilian Network for Health Technology Assessment (REBRATS) recommends the use of observational studies to develop economic evaluations for both effectiveness and safety data. However, the extent of use of such data in Brazil remains undetermined. Our objective was to identify the requirements and needs for epidemiological data regarding HTA submissions in Brazil.  METHODS: We reviewed HTA requirements, reports and dossiers from the Brazilian HTA commission (CONITEC) for epidemiological data aimed at incorporation. Additionally, we searched Brazilian guidelines and regulations about principles for real world data requirements for HTA.  RESULTS: CONITEC issued 119 reports between the time of its establishment (April/2011) and the date of our analysis (December 08^th, 2014). The Committee reported lack of real world studies in 11.8% of the submissions (14 of 119 reports), including the need of epidemiological studies (prevalence and incidence) (n=8), safety and efficacy trials (n=3), safety study (n=1), epidemiological and clinical characteristics studies (n=1) and resource use and cost-of-illness analyses (n=1). The lack of epidemiologic data was the most common issue (8 of 14 reports). However, real world data regarding safety, effectiveness and clinical characteristics were also critical (7 of 14 reports).  CONCLUSIONS: Our analysis showed that use of real world data in Brazil remains an unmet need for HTA.