Brasília – Anvisa presented the latest results of its Strengthening and Modernization Plan during the GECEIS plenary held on Monday (24), reporting significant advances in regulatory efficiency. The agency announced a 40% reduction in the post-registration backlog for medical devices, the elimination of the radio-pharmaceuticals queue, and a decrease in the average analysis time for biologics from 22 to 9 months. It also highlighted accelerated timelines in clinical-trial evaluations and inspection processes, driven by reliance mechanisms and internal restructuring.

The agency further reported the entry of 102 new regulatory specialists, the largest staff expansion since 2014, accompanied by R$ 25 million in investments in digital modernization, artificial-intelligence tools and infrastructure upgrades. A new Situation Room and a Monitoring Committee were created to track the implementation of the modernization plan, with the goal of halving regulatory queues within six months and normalizing workflows within one year.

Source: Anvisa

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