A new business landscape emerges for Brazil’s regulated sector

The appointment of economist Leandro Pinheiro Safatle as Anvisa’s new Director-President, along with the inauguration of the agency’s new board (directors) in September 2025, marks the beginning of a new institutional approach with direct impact on the regulatory and business environment in Brazil. Public statements made by the new leadership point to a shift in priorities: speeding up product registration processes and focusing on innovation—two key areas for companies operating under sanitary regulation.

Delays in product registration and approval have long been a barrier to business development in the sector. With Anvisa now signaling a more agile and strategic posture, companies may find new opportunities to revisit projects that were previously shelved or considered unfeasible. The expectation is that this shift will have immediate effects, with lasting impact over the next two to three years.

This new regulatory environment is likely to increase competition and trigger a wave of innovation and new product launches. Companies that act early may gain significant competitive advantages, whether by restarting old projects or structuring new ventures with commercial partners. Anvisa’s institutional shift could be a key driver of expansion in the sector, especially when compared to its performance in recent years.

It is advisable for companies to start preparing now. This includes reviewing product portfolios, reassessing market entry strategies, accelerating commercial discussions, and revisiting contracts that have been on hold. Acting early may be crucial to securing space in a market that is expected to become more dynamic and competitive in the short term. Additionally, the agency’s new posture may help improve the overall business climate, attract investment, and strengthen the confidence of both domestic and international players.

Companies that understand this regulatory shift and prepare strategically will be better positioned to grow, diversify their offerings, and expand their operations. This change represents not only an operational improvement but a broader transformation of the regulated sector.

We continue to monitor institutional developments and support our clients through every strategic and operational step that helps them lead and stand out in this competitive environment. Anticipating these changes is key to achieving success through innovation and new business opportunities.

This material is for informational purposes only and should not be used in isolation for decision-making. Specific legal advice may be provided by one of our attorneys. Copyright reserved to KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.