What Is ANVISA’s Reliance Pathway for Biologics?

In most regulatory contexts, reliance refers to a mechanism that allows one authority to draw on the assessment work of another — reducing duplication, compressing timelines, and leveraging existing scientific review. ANVISA formalised this framework under RDC 741/2022 and operationalised it for medicines, biological products, and vaccines through IN 289/2024, effective April 2024. For companies working with biologics, however, reliance does not function as a straightforward shortcut. The structural characteristics of this product class — molecular complexity, process dependency, inherent variability — mean that ANVISA’s reliance pathway operates under conditions that small-molecule submissions do not face in the same way. Understanding what the pathway does, and what it does not remove from the submission requirements, is the starting point for any biologics programme planning market entry in Brazil.

THE MECHANISM: WHAT THE AREE PROCEDURE COVERS

The operative concept within ANVISA’s reliance framework is the Autoridade Reguladora Estrangeira Equivalente — AREE. An AREE is a foreign regulatory authority that ANVISA has formally designated as meeting equivalence standards in terms of regulatory practices, technical rigour, and transparency. IN 289/2024 designates eight AREEs applicable to biological products: EMA, FDA, WHO, Health Canada, MHRA, Swissmedic, TGA, and PMDA — the latter limited to quality information only, and WHO the only authority whose scope covers all product categories, including vaccines and APIs. When a biological product holds a valid marketing authorisation from one of these authorities, the applicant may request the procedimento de análise otimizado — the optimised analysis procedure — at the time of submission to ANVISA.

The procedure allows ANVISA to use a prior AREE assessment as reference material in its own review. It does not transfer the conclusions of that evaluation, and it does not replace ANVISA’s independent decision-making authority. The pathway accelerates the analysis process — it does not reduce the substantive review.

WHY BIOLOGICS ARE A SPECIFIC CASE WITHIN THE FRAMEWORK

Biological products present a distinct challenge within any reliance framework because they are defined by their manufacturing process in a way that small molecules are not. A biologic approved by EMA was evaluated against a specific manufacturing platform, cell line, production conditions, and comparability dataset — all of which belong to a particular time, site, and process configuration. When that product enters the ANVISA reliance pathway, the prior approval serves as a reference point, not a transferable conclusion.

For biosimilars, this distinction is structural. The comparability exercise performed for the reference authority does not satisfy ANVISA’s own comparability requirements under RDC 875/2024. Brazil maintains its own reference biological product standards, and the evidentiary framework for demonstrating similarity is applied independently — regardless of what another AREE concluded. This reflects the fact that ANVISA is evaluating the product as it will be manufactured and distributed for the Brazilian market, under Brazilian quality and safety standards.

WHAT REMAINS MANDATORY REGARDLESS OF AREE STATUS

Three documentation requirements remain in place for biological products even when the optimised analysis procedure is granted:

• GMP certification at the site level —  The manufacturing site responsible for supply to the Brazilian market must meet ANVISA’s own GMP requirements under IN 292/2024. An existing European GMP certificate supports the process but does not replace the site-level verification that ANVISA conducts independently.
• The quality dossier —  Technical documentation submitted to ANVISA must be structured to answer the specific questions that ANVISA’s review framework asks — which, for biologics, does not map one-to-one with the dossier built for EMA or FDA.
• Product equivalence conditions —  The product submitted for registration in Brazil must meet ANVISA’s equivalence criteria: same formulation, same manufacturing process, same specifications as the product authorised by the reference AREE. Any deviation requires explicit justification within the submission.

The reliance pathway reduces the analytical burden on ANVISA — not the documentation burden on the applicant. For biologics in particular, the distinction matters at the planning stage.

If your programme already holds an EMA or FDA authorisation and you are assessing what a Brazil submission would require, the blog Your Biologic Is Approved by EMA. Here Is What ANVISA Will — and Won’t — Accept as Reliance maps the specific conditions that most often generate gaps for global biologics teams entering the ANVISA pathway.