Brasília – A new regulatory framework for herbal medicines approved earlier this month by Brazil’s National Health Surveillance Agency (ANVISA) is expected to unlock growth opportunities for the herbal products sector, according to an analysis published by Valor Econômico on December 26. Industry representatives argue that the revised rules could help transform a traditionally fragmented segment into a more competitive and innovation-driven market.

The updated framework is seen as a turning point for companies that rely on plant-based active ingredients, as it introduces regulatory pathways better aligned with the specific characteristics of herbal medicines. By differentiating regulatory requirements according to levels of scientific evidence and traditional use, the new model may reduce entry barriers that previously limited product development and formal registration.

Executives and sector specialists interviewed by Valor highlight that Brazil, despite its vast biodiversity, has historically underperformed in the commercialization of herbal medicines compared with European markets. The new rules are expected to encourage greater private investment, stimulate partnerships with research institutions and promote the sustainable use of native plant species, potentially expanding both domestic supply and export capacity.

From a market perspective, the framework may also improve regulatory predictability, a key factor for long-term investment decisions. While companies still face challenges related to scaling production and ensuring consistent quality standards, stakeholders view the regulatory shift as a necessary condition for positioning herbal medicines as a more relevant segment within Brazil’s broader pharmaceutical and health products market.

Source: Valor Econômico


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