BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
lined clearance routes for lower-risk medical devices, all administered by ANVISA. For medicines, ANVISA operates a formal priority review regime under the current prioritisation frame- work established by RDC No 1,001/2025 (effective 15 January 2026), which replaced the former RDC No 204/2017 that was in force since 2008. This framework allows certain marketing authorisation applications, post-approval variations and related regulatory filings to be classified as priority and assessed ahead of the standard review queue, based on objective criteria such as public health relevance, strategic importance to the Brazilian health system or the need to mitigate risks of shortage. Priority status affects review order and timelines but does not waive technical, quality safety or efficacy requirements. In parallel, Brazil has significantly advanced regula- tory reliance as an expedited pathway for medicines and biological products. Under RDC No 741/2022, ANVISA may rely on assessments performed by recognised equivalent foreign regulatory authorities ( autoridades reguladoras estrangeiras equivalentes – AREEs), enabling an optimised review that focuses ANVISA’s analysis on local specificities while lever- aging foreign regulatory work products. The practical implementation, scope and eligibility conditions of this reliance-based approach are detailed in Norma- tive Instruction No 289/2024, which applies to both initial marketing authorisations and post-approval life cycle management. While reliance does not amount to automatic approval, it can materially reduce review complexity and timelines. It is also worth noting that, at the end of 2024, ANVISA introduced a simplified procedure for the registration, post-registration changes and renewals of specific categories of medicines and biological products under RDC No 954/2024. This framework applies, in sum- mary, to products such as generics, similar, specific medicines, herbal medicines, radiopharmaceuticals and biological products, where such products are linked to a “reference” or “matrix” application (eg, within the same economic group or in the context of product development partnerships or technology- transfer arrangements), and relies on a tailored docu-
mentation model anchored to the underlying matrix dossier. In addition, RDC No 997/2025 introduced excep- tional and temporary measures to reduce ANVISA’s backlog and accelerate the review of procedures related to clinical research, marketing authorisations and post-approval changes for medicines and bio- logical products. The rule provides tools such as the evaluation management plan ( plano de gestão anual – PGA), allows the creation of dedicated queues and, in limited circumstances, permits adjustments to the chronological order of reviews to increase throughput. It also contemplates reliance and optimised technical assessment approaches, as well as practical mecha- nisms such as queue substitution upon formal with- drawal and early risk classification of potential defi- ciencies. For medical devices, Brazil does not yet operate a standalone fast-track or priority programme equiva- lent to those available for medicines. However, the regulatory system is inherently risk-based, which pro- duces a de facto expedited pathway for eligible prod- ucts. Lower-risk devices (Classes I and II) are gener- ally subject to a simplified notification procedure, with limited pre-market review, whereas higher-risk devices (Classes III and IV) require full registration and sub- stantive technical assessment. As a result, time to market varies significantly by risk class, with simpli- fied notification functioning as the primary accelera- tion mechanism in the device space. 4.2 Regulatory Reliance Brazil has adopted regulatory reliance as part of ANVI- SA’s decision-making model, in line with international good regulatory practices. Under this framework, ANVISA may give significant weight to assessments, inspection outcomes and regulatory decisions issued by AREEs or trusted institutions, while fully preserving its autonomy and responsibility for the final decision, pursuant to ANVISA RDC No 741/2022 and Law No 9,782/1999. Reliance is implemented through an optimised review procedure, allowing the use of instructive documenta- tion issued by an AREE as a unique or complementary reference, subject to admissibility and product com-
44 CHAMBERS.COM
Powered by FlippingBook