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1 min read
Strategic Landscape
From harmonization in Brazil to regulatory reliance in Brazil: the country’s evolving technical position.
Brazil is consolidating its role not only as a primary pharmaceutical market in Latin America, but also as a regulatory authority with a growing global outlook. In recent years, ANVISA has adopted harmonized international standards, including the Common Technical Document (CTD), ICH guidelines, and PIC/S Good Manufacturing Practices. This harmonization in Brazil has progressively enabled the implementation of regulatory reliance in Brazil as part of the ANVISA regulatory framework.
These mechanisms include the acceptance of GMP inspections conducted by agencies such as the FDA and EMA, the consideration of prior clinical evaluations for innovative products, and active participation in international regulatory networks such as ICMRA and Red PARF, which promote technical cooperation among high-surveillance authorities.
Since 2022, ANVISA has formalized this approach through specific regulations — namely, RDC 741/2022 and IN 289/2024 — aimed at enabling the systematic adoption of regulatory reliance in Brazil for medicines, vaccines, and active substances. From 2025 onward, these measures are expected to result in measurable reductions in review timelines, without compromising scientific rigor, ultimately transforming the drug approval process in Brazil.
This evolution is not a loss of regulatory autonomy but rather a technical shift toward efficiency, transparency, and interoperability. When cooperation is built on common standards and mutual confidence, it becomes a powerful tool for expanding access and ensuring regulatory certainty.
In this context, Freyr supports pharmaceutical companies seeking to align with and benefit from this new ANVISA regulatory framework, offering specialized technical services to:
- Assess whether a product’s regulatory history qualifies it forreliance pathways within the drug approval process in Brazil.
- Align the dossier with ANVISA’s expectations and format requirements.
- Design a submission strategy that prioritizes efficiency and regulatory agility.
Brazil’s regulatory landscape is already changing. The real differentiator will be the ability to anticipate its direction.
Let’s talk
If you’re wondering whether your product qualifies for regulatory reliance in Brazil or need technical guidance to plan your registration strategy under the evolving ANVISA regulatory framework, schedule a virtual consultation with our LATAM regulatory experts.
We can review your case at no cost, with full confidentiality and a practical, tailored approach. Contact us.
