Brasília – Brazil’s National Health Surveillance Agency (Anvisa) reports early progress in its action plan aimed at reducing regulatory backlogs for medicines, vaccines, medical devices and inspections. The initiative, launched in November 2025, seeks to cut waiting lines by half within six months and normalize processing timelines by the end of 2026, according to the agency’s president, Leandro Safatle.

Initial results show significant reductions in several areas of regulatory review. Anvisa reports a 60% decrease in analysis time for clinical trial authorizations and in the backlog of radiopharmaceutical registration requests, while the pending stock of post-registration changes for medical and orthopedic devices has fallen by about 50%. The agency also indicates that the number of completed reviews reached record levels in the first two months of 2026.

The strategy combines operational measures and structural reforms, including process reorganization, reliance on international regulatory assessments, stronger internal task forces and investments in digital tools and artificial intelligence to improve regulatory efficiency and predictability.

Source: Futuro da Saúde
Read more: https://futurodasaude.com.br/anvisa-plano-reducao-filas/