ANVISA’s Regulatory Agenda is a fundamental pillar for predictability and the evolution of the regulatory environment in Brazil. Its relevance goes beyond the normative aspect, directly impacting the strategic business planning in sectors such as health, food, cosmetics, and technology.
Analyzing the trends and changes proposed in this document is essential for companies and entrepreneurs. This agenda defines the directions of regulations, indicating updates, revisions, and new norms that can affect the manufacturing, marketing, and distribution of products.
Deeply understanding the nuances of the Regulatory Agenda offers competitive advantages. Anticipating these changes allows for the adjustment of strategies, investment in research and development aligned with future regulations, and consequently, being ahead in launching innovative and compliant products.
Moreover, close observation of these guidelines can boost strategic partnerships, targeted investments, and the development of solutions that are in line with regulatory expectations, reducing risks and streamlining processes.
For companies, whether in the adaptation of processes or in the launch of new products, understanding the Regulatory Agenda is a competitive differentiator. It will not only mitigate risks but will also serve as a compass to navigate a dynamic and complex regulatory environment..
ANVISA’s Board of Directors (Dicol) approved on December 15, 2023, through the Deliberative Circuit – CD No. 1.312, the Regulatory Agenda for the next two years. Published by Ordinance No. 1409, the 2024-2025 Agenda consists of 172 regulatory themes distributed across 16 macro themes.
Among the highlighted subjects, Medicines (45 themes), Food (34), and Cross-Cutting Issues (23) receive greater attention. It is interesting to note that 62% of the themes are related to the previous Agenda, while 66 are new regulatory themes. Exploring the nuances of the new regulatory agenda, we observe key points that are transforming the regulatory landscape:
Innovation in Medical Devices: ANVISA is paving the way for innovations that will transform patient care. With a keen eye on emerging technologies, the regulator is shaping an environment conducive to the rapid and safe advancement of new medical devices.
In Vitro Diagnostic Devices (IVD): Currently, the sector faces a significant gap: the absence of legislation and clear criteria for the prior analysis of IVD devices. This
situation generates uncertainties, as the regulated sector lacks guidelines on how and when such analyses should be performed before the registration stage.
Electronic Instructions for Lay User Products: In response to a growing demand from the regulated sector, which seeks to optimize material and logistical resources and address environmental concerns, ANVISA is moving to allow instructions for use in electronic format for lay user devices. This change aligns with existing practices for professional use devices and reflects a commitment to sustainability and regulatory modernization.
International Harmonization: ANVISA is adopting a strategic approach to integrating the assessments of recognized international regulatory authorities into its own analyses of medical devices. This alignment promises to accelerate the Brazilian market’s access to global innovations and optimize the review process, making it more agile and effective.
In the 2nd stage (completed) of the process, contributions were analyzed and regulatory themes were prioritized and selected. The analysis of the 258 contributions from society resulted in 123 prioritized groups to compose the 2024-2025 Agenda, totaling 172 themes after the inclusion of 91 and exclusion of 21 in relation to the preliminary list.
For more details on ANVISA’s 2024-2025 Regulatory Agenda and its developments, check out the links:
- Detailed translated (English) list of themes of the 2024-2025 Regulatory Agenda (spreadsheet)
- Summarized list of themes of the 2024-2025 Regulatory Agenda.
- Presentation of the 2024-2025 Regulatory Agenda.
Being updated and engaged in the discussion about ANVISA’s Regulatory Agenda is more than a legal requirement; it is a smart strategy for business success in an increasingly dynamic and regulated market.
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