RWE as a regulatory currency — the gap between the world and Brazil

Real-world evidence (RWE) has ceased to be merely supplementary data in drug development. Leading regulators now treat it as a practical component throughout the entire regulatory lifecycle: the FDA, with its RWE program and 2018 framework (following the 21st Century Cures Act), and NICE, with its 2022 Real-World Evidence Framework, guide the use of RWE in evaluation, reimbursement, and coverage decisions.

And in Brazil? We have made progress, but also have shortcomings. A common misconception is to present the Sentinel Network, from Anvisa (Brazilian Health Regulatory Agency), as one of the largest RWE (Research, Work, and Evidence) databases in the country. The official definition is different: it is a network of services and an active observatory of the performance and safety of health products, in the context of post-market monitoring (technovigilance, armacovigilance, and hemovigilance). It is an important surveillance asset—but not a large, structured national database for comparative effectiveness studies.

To expand the role of RWE in HTA, Brazil also needs to look at DATASUS, clinical records, administrative databases, and supplementary health data—paying attention to the linkage between databases, governance, quality, completeness and representativeness of the data, confounding control, and analytical transparency. The rule of thumb is simple: use the appropriate data to answer the appropriate question, instead of treating any routine data as regulatory evidence.

The institutional movement has already begun. Rebrats held a public consultation on methodological guidelines and promoted discussions on real-world data in the SUS (Brazilian Unified Health System). Those who build methodological competence in RWE today—in study design, data quality, and analytical transparency—tend to be better prepared as the use of RWE in HTA (Health Technology Assessment) expands.

Sources: FDA – Framework for FDA's RWE Program (2018); NICE – Real-World Evidence Framework (2022); Anvisa – Sentinel Network; Rebrats. Accessed July 2026.