The Brazilian Health Regulatory Agency (ANVISA) enacted its Regulatory Agenda, covering 146 initiatives across 15 macro-themes. Those initiatives will be prioritized by ANVISA’s regulatory process for the 2021-2023 period.
The Brazilian Health Regulatory Agency (ANVISA) enacted its 2021-2023 Regulatory Agenda, covering 146 initiatives to be prioritized by the agency’s regulatory process in the 2021-2023 period. The initiatives are organized within 15 macro-themes, as follows:
- Medicines – 29 initiatives;
- Health Products – 21 initiatives;
- Transversal topics – 21 initiatives;
- Ports, Airports, and Borders – 12 initiatives;
- Food Products – 11 initiatives;
- Health Services – 11 initiatives;
- Blood, Tissues, Cells and Organs – 8 initiatives;
- Cosmetics – 7 initiatives;
- Pesticides – 6 initiatives;
- Sanitizing Products – 6 initiatives;
- Tobacco – 4 initiatives;
- Pharmacopeia – 3 initiatives;
- Health Services – 3 initiatives;
- Analytical Laboratories – 2 initiatives;
- Brazilian Health Regulatory System (SNVS, in the Portuguese acronym) – 2 initiatives; and
The initiatives can be found in this Official Gazette of the Federal Government Publication’s Annex and at ANVISA’s website. The latter provides a detailed list in spreadsheet format, which discloses the regulatory stage (i.e., initial launch, regulatory impact analysis, public consultation, or final deliberation) scheduled to be carried out in 2021, for each initiative. It also provides the context and motivation for each initiative.
Reported in the 18th edition of the Regulatory Report, the agenda was the subject of public consultation, whose details are available at ANVISA’s website.