Brasília – The Brazilian Health Regulatory Agency (Anvisa) announced this Friday (7) a comprehensive package of measures to accelerate the registration of medicines, medical devices, and clinical trials, with the goal of ensuring that reviews for non-prioritized drugs are completed in up to one year. Currently, some applications take as long as three years to be finalized.

Among the main changes is the reorganization of the registration queue, allowing companies to swap the order of applications. A firm may, for instance, withdraw one pending request to prioritize another product of greater strategic or market relevance. According to Director Daniel Meirelles, who proposed the reform, the change “will reduce the backlog and direct Anvisa’s resources toward products the industry truly intends to commercialize,” noting that about 40% of approved medicines are never marketed.

The plan also foresees the adoption of artificial intelligence tools to support dossier analysis and document classification, as well as the use of data and regulatory opinions from foreign agencies, such as the U.S. FDA and the European Medicines Agency (EMA), to streamline technical evaluations. Anvisa and the Ministry of Health also announced a R$ 25 million investment in digital transformation and a reinforcement of personnel, with 250 new positions to be created and more than 100 pre-approved professionals expected to be called to strengthen the agency’s workforce.

Anvisa President Leandro Safatle described the initiative as “an exceptional process to bring agility and efficiency to the registration of products.” The announcement was met with mixed reactions from the pharmaceutical sector. Renato Porto, president of Interfarma, said the agency should prioritize “the interests of patients” and cautioned that the queue-swap mechanism could benefit companies with a large portfolio. Nelson Mussolini, from Sindusfarma, expressed similar concerns, warning that the rule might “undermine transparency and fair competition.” Meanwhile, Reginaldo Arcuri, from Grupo FarmaBrasil, supported the measure, calling it a necessary response to a “regulatory emergency.”

Source: Folha de S.Paulo