Brasília – Brazil’s health regulatory agency, Anvisa, under new leadership by director-president Leandro Safatle, has announced a strategic push in 2026 to significantly reduce its backlog of regulatory analyses and to prioritize innovations developed within the country. The initiative responds to concerns that the pace of internal approvals has lagged behind the rapid emergence of new health technologies.

In an interview with Agência Brasil, Safatle outlined a series of measures approved by the agency to optimize process flows for medicines, vaccines, medical devices and inspections, aiming to halve the current backlog within six months and normalize review timelines within a year. These include forming internal task forces, leveraging regulatory reliance on trusted foreign data, and enhancing coordinated reviews of similar products, while maintaining scientific rigor and safety standards.

Anvisa has also created a Committee of Innovation to monitor priority projects, such as polilaminina (a Brazilian-developed compound for spinal injury), a chikungunya vaccine, methods to control dengue and new endoprostheses, and plans to reinforce its workforce with around 100 new specialists. The agency’s long-term goals include consolidating its role as a regional and global reference authority in health regulation.

Source: Agência Brasil