Brasília – At the IV Brazilian Health Innovation Summit, a roundtable discussion placed clinical research at the heart of Brazil’s innovation agenda, spotlighting regulatory challenges and strategic priorities.

Moderated by Rosana Mastellaro (Sindusfarma), panelists including Adriane Alves (Anvisa’s COPEC), Thiago Mares Guia, and Meiruze Freitas debated how the recent RDC 945/2024 introduces stricter deadlines across all regulatory stages, allows earlier importation of inputs, and enables continuous document submission — all aimed at boosting agility without sacrificing patient safety. More than 54% of clinical studies in Brazil currently take up to 180 days to begin after Anvisa approval, a delay seen as a major bottleneck.

Beyond regulation, the debate emphasized the need for a robust industrial policy to support biotechnological capacity and reduce dependence on multinational-led trials. Panelists also called for decentralization of research centers, pushing for capacity building across all Brazilian regions to ensure more equitable access and national competitiveness.

Source: Panorama Farmacêutico

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