Anvisa publishes Regulatory Agenda for 2024-2025
On December 15, 2023, the Brazilian Health Regulatory Agency (“Anvisa”) approved the Regulatory Agenda for the 2024-2025 cycle.
Published in the Federal Register of December 18, 2023, through Ordinance 1409/2023, the 2024-2025 Agenda has 172 regulatory topics distributed in 16 macro-themes, aligned with the strategic objectives of the Strategic Plan 2024-2027 and feasible to implement during the biennium.
Among the 172 topics, 106 of them (62%) are related to the 2021-2023 Agenda, while the remaining 66 are new topics not foreseen in the previous Agenda.
The Regulatory Agenda is a planning instrument with the purpose of providing predictability and transparency to Anvisa’s regulatory activity.
Among the subjects with the most regulatory topics are:
- Medicines (45);
- Food (34); and
- Cross-Cutting Issues (23).
The summary list of the topics on the 2024-2025 Agenda can be accessed at this link, and the detailed spreadsheet with the topics can be accessed at this link.
CONTEXT AND CONSTRUCTION OF THE 2024-2025 AGENDA
During 45 days of public consultation open to the regulated sector and civil society, 1,449 contributions were received. The macro-theme with the highest number of contributions was (i) food, with 480 contributions; followed by (ii) medicines, with 320; (iii) cross-cutting issues, with 202; (iv) health services, with 86; and (v) health products, with 68.
After analyzing the contributions, 91 topics were (i) included and (ii) 21 were excluded, resulting in a final list of 172 topics.
HIGHLIGHTS
The list of topics is presented in a summarized format, which shows the number, the related strategic goals, and a detailed spreadsheet, which contains the description of the regulatory topic, the strategic objective related to it, the significant impact on international trade, the rules related to the topic, the sectors affected and the institutional contact.
Please find the highlights topics trough this link.
FOLLOW-UP AND RELEVANCE OF THE TOPICS
With the preliminary disclosure of the topics, the Agency allows stakeholders to prepare to discuss and adapt to possible changes, contributing to the construction of a stable regulatory environment.
Our Life Sciences & Healthcare team will monitor the development of the 2024-2025 Agenda and is available if you have any questions about the topics and their possible developments, through the e-mail: lifesciences@soutocorrea.com.br.