On August 20, 2026, Brazil’s Health Regulatory Agency (ANVISA) opened a technical contribution period to support the review of Resolution RDC No. 55, of December 16, 2010, which governs the marketing authorization of new biological products and biological products in Brazil. Comments can be submitted through September 17, 2026, and the initiative is led by the General Management of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs and Advanced Therapy Products (GGBIO).

This topic is part of the regulatory agenda for the 2026–2027 biennium, specifically under item 9.4, “Update of technical and regulatory requirements for the marketing authorization of biological products”—which has the strategic objective of enabling safe access to products essential for the population’s health.

What’s currently in force

Resolution RDC 55/2010 sets out the minimum requirements for the marketing authorization of new biological products and biological products in Brazil — a category that covers vaccines, hyperimmune sera, blood derivatives, biopharmaceuticals, monoclonal antibodies, and medicines containing live, attenuated, or killed microorganisms. The Resolution also defines core concepts for the field, such as comparator biological product and comparability, along with the three regulatory pathways available for authorization: the complete development pathway, based on complete, product-specific data, as well as the individual pathway (for “non new” biological products, with a reduced scope of non-clinical studies and Phase I and II clinical studies that are not necessarily comparative, involving a comparison with an already authorized product) and the comparability development pathway (with the presentation of the complete comparability exercise, for biosimilar products, based on demonstrating equivalence to an already authorized product).

Since its original publication, Resolution RDC 55/2010 has undergone some updates — such as Resolution RDC 875/2024 and RDC 948/2024, which adjusted provisions respectively related to the comparability development pathway and to administrative documentation. The result is a rule that has accumulated, besides these targeted adjustments, more than a decade of without technical and scientific adjustments, without a complete structural review.

According to the description of the list of topics in the 2026-2027 Regulatory Agenda, RDC 55/2010 is old and requires updates in light of the technological, scientific and regulatory advances achieved since its publication.

In its review, ANVISA seeks the harmonization with the Common Technical Document (CTD) format, the discussion of the requirements for the authorization of biosimilars and the possibility of classifying some categories of biological products as low complexity.

Why revise it now

The update responds to the transformation in the biologics and biopharmaceuticals sector through the last years. The global market for biologic products already exceeds US$500 billion and continues to project annual growth above 6%, as the industry’s focus shifts from large-scale synthetic medicines toward precision therapeutic platforms — antibody-drug conjugates, oncology immunotherapies, autoimmune disease treatments, and, increasingly, cell and gene therapies capable of treating rare genetic diseases with a single dose.

This progress has been driven, more recently, by the incorporation of artificial intelligence into biopharmaceutical development, from predictive protein and molecule design to toxicity prediction, patient selection for clinical trials based on genomic data, and automation of sensitive manufacturing steps such as bioreactor fermentation. These tools shorten timelines that have historically exceeded a decade and mitigate the high failure rates typical of traditional biotech development.

Against this landscape, ANVISA recognizes the need to update the regulatory framework in light of the experience accumulated since 2010, the scientific and technological advances in the sector, and the evolution of national and international regulatory references — in step with the pace of innovation that now defines the biopharmaceutical industry.

How to take part

The Agency invites companies operating in the sector, representative associations, scientific bodies, and other institutions active in the field of biological products to submit technical contributions through September 17, 2026, via the form made available by ANVISA. With this, ANVISA seeks to understand the major challenges faced by the regulated sector in applying and complying with the requirements of RDC 55/2010.

According to the Agency, this is a preliminary stage focused on gathering technical input. Later on, the regulatory steps set out in the standard process will be conducted. Sector participation is key to identifying opportunities for improvement, assessing the feasibility of the proposed requirements, and anticipating potential regulatory impacts.