Brazil – Anvisa approves Regulatory Agenda 2024-2025

The Collegiate Board of Directors (DICOL in Portuguese) of the National Health Surveillance Agency (ANVISA in Portuguese) approved through the Deliberative Circuit (CD 1.312, of December 15, 2023), the Regulatory Agenda (RA) for the 2024-2025 cycle.

The document, published in Ordinance 1.409/2023, is composed of 172 regulatory topics distributed in 16 macro-themes. According to the Normative Agenda Manual, the themes are aligned with the strategic objectives of the 2024-2027 Strategic Plan and are feasible to advance during the Agenda’s term.

The construction of the RA 2024-2025 was initiated through a consultation directed to society and entities of the National Health Surveillance System (SNVS) on the regulatory topics that should be addressed by Anvisa in the next biennium. On July 21, 2023, Public Notice 9 was published to receive comments from any interested party regarding the preliminary list of 102 regulatory proposals for the Agency’s AR 2024-2025, as well as suggestions for the inclusion of other regulatory topics.