What to Expect in 2025: Brazil’s Regulatory Updates for Biological Product Registration

 

Introduction

Brazil is taking significant strides toward modernizing its Regulatory framework for biological products and biosimilars. In 2024, the Brazilian Health Regulatory Agency (ANVISA) introduced critical updates that laid the foundation for more harmonized, science-based oversight. With 2025 shaping into a transformative year, stakeholders in the life sciences sector must stay informed and proactive.

2024: Strengthening the Regulatory Foundations

RDC 875/2024: Enhancements to the Biosimilar Pathway

Issued in May 2024, RDC 875/2024 introduced updates to the comparability pathway for biosimilars. The regulation allows for:

  • Waiving of certain non-clinical and comparative clinical studies when scientifically justified
  • Utilization of international reference products approved by Authorities Recognized as Equivalent (AREEs) when local comparators are unavailable and since they are manufacturing at the same manufacturers as those of the medicine registered in the country or having carried out bridge studies if it is not possible to show that the manufacturers are the same.
  • Alignment with global guidelines such as those from WHO and ICH.

This rule has been in force since June 17, 2024.

RDC 876/2024 changed by RDC 913/2024: Simplifying Post-Registration Requirements

In June 2024, ANVISA amended RDC 413/2020 to streamline post-registration change processes. Key changes include:

  • Clearer definitions of major and minor variations
  • Reduced documentation requirements for specified categories
  • Shortened timelines for ANVISA’s assessment of post-approval changes

This rule has been in force since June 03, 2024. 

New Subject Codes Introduced

In August 2024, ANVISA launched updated subject codes for more accurate classification and tracking of biological products. The revised system categorizes submissions by product type, including:

  • Monoclonal antibodies
  • Vaccines
  • Recombinant proteins
  • Hyperimmune serums
  • Blood derivatives and probiotics

2025 Outlook: Key Regulatory Priorities

ANVISA’s 2024–2025 Regulatory Agenda places significant emphasis on modernizing and harmonizing Brazil’s biologics regulations. Below are the key areas of focus for the year ahead.

1. Revision of Technical Requirements for Biological Product Registration (RDC 55/2010)

ANVISA plans to revise the technical, scientific and regulatory requirements governing the registration of biological products. The review seeks to discuss:

  • The relevance of accepting real-world data
  • The possibility of classifying some categories of biological products as low complexity, among other points.
  • In addition, this project will contemplate the ongoing amendment of RDC No. 55/2023 for the purpose of updating the criteria for registering biosimilar products

2. Consolidation of Post-Registration Norms (Revision of RDC 73/16, RDC 708/22 and RDC 413/20)

ANVISA aims to unify and consolidate existing post-registration requirements into a single Regulatory framework. Expected improvements include:

  • Consolidation of general aspects of the three existing regulations on post-registration of medications referring to synthetic and semi-synthetic medications (RDC 73/2016), herbal medications and traditional herbal products (RDC 708/2022) and biological products (RDC 413/2022), maintaining the specificities of each category of medication.
  • Standardized classification of variations
  • Consistent documentation templates for different types of updates
  • Centralized portal access for more efficient submission and tracking

3.  Update on clinical research into advanced therapy products, in light of the publication of Law No. 14,874/2024 (Update of RDC No. 506/2021)

Brazil's clinical research framework will also undergo significant updates. Anticipated revisions include:

  • Contribute to the development of new promising technologies in the health sector in the country
  • Defined review timelines: ANVISA is required to answer to clinical trial applications within 90 business days, enhancing predictability for sponsors
  • Parallel Ethical and Regulatory Reviews
  • Enhanced Participant Protection.

4. Implementation of e-CTD

Discuss the best way to regulate e-CTD in Brazil, in line with the ICH:

  • This is a requirement for Anvisa to be classified as a level IV regulatory agency by the WHO.
  • Anticipate and respond effectively to health crises and public health emergencies

5. Health requirements for the regulation and monitoring of manufactured drugs for human use throughout their life cycle. This review aims:

  • harmonize the requirements related to the protocol, the documents required to identify the products and companies involved and, eventually, according to the assessment that will still be carried out, the definitions contained in the standards.
  • Guidelines for Good Assessment Practices will also possibly be included.

6. Review of the regulatory framework that deals with post-registration changes to biological products and their cancellation.

  • The project includes an amendment to RDC No. 413/2020, which deals with the post-registration and cancellation of biological products, which is in progress
  • This proposal seeks to modify art. 22 of the standard, in order to optimize the process of protocols for modifications and their analysis by Anvisa.
  • With this, a decrease in the number of documents received is expected and, therefore, a reduction in the analysis queues and administrative costs involved in similar analyses, without prejudice to the technical evaluation carried out by GPBIO/GGBIO.
  • Additionally, as determined by DIRE2, the project should include a broader review of RDC No. 413/2020 and IN No. 65/2020, which complements it, in order to verify the need for adjustments or updates that may also contribute to efficiency gains in the application of the standard and simplification, whenever possible.

7. Review of the criteria for classification in the priority category of petitions for registration, post-registration and prior consent in clinical research of drugs, according to public relevance (Review of RDC 204/2017 and RDC 205/2017)

  • The current criteria for prioritizing the analysis of registration and post-registration petitions need to be reviewed
  • So that they become more specific and consistent with the benefit and effort required by the areas for the evaluation of prioritized petitions.
  • This topic has a major impact on the activities of the areas and also on public health.
  • It is important to review the criteria for commercialization, prioritization (Ex: new concentration of ibuprofen prioritized because it is a pediatric indication), definition of rare disease and granting of a term of commitment.
  • Enable safe access to products and services essential for the health of the population.

8. Regulation of Innovation in the areas of medicines and biological products.

  • In line with the law that establishes the Legal Framework for Startups and Innovative Entrepreneurship, DIRE2 initiated the discussion at Anvisa and facilitated the Pharmaceutical Innovation Workshop in order to highlight the importance of establishing a regulatory strategy for radical innovation in Brazil.
  • The regulatory impact on radical innovation will be significant without giving up the regulatory framework that guarantees the safety, efficacy and quality of innovations.
  • It is also important to ensure a regulatory environment favourable to the creation and adoption of innovative technologies.
  • Contribute to the development of new promising technologies in the health area in the country.

How Companies Can Prepare

To navigate these upcoming changes successfully, companies should consider the following:

  • Align early with ANVISA through scientific advice meetings and pre-submission consultations
  • Update Regulatory dossiers to reflect revised quality and clinical data expectations
  • Leverage international reference products and reliance pathways to reduce development timelines
  • Strengthen post-registration planning, particularly for variations and renewals
  • Invest in submission readiness, especially for digital formats and centralized portals

Conclusion

2025 marks a pivotal shift in Brazil’s Regulatory landscape for biological products. With ANVISA focusing on updated technical requirements, streamlined lifecycle protocols, and modernized clinical pathways, the system is becoming more agile, transparent, and globally aligned.

Our experts can help you stay ahead through comprehensive dossier preparation and technical writing, eCTD formatting and ANVISA submissions, strategic support for post-approval change management, and end-to-end clinical trial Regulatory guidance.

Connect with us to align your strategy with Brazil’s 2025 Regulatory framework.

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