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

 

Introduction

Brazil is taking significant steps to modernize its regulatory framework for biologics and biosimilars. In 2024, the Brazilian Health Regulatory Agency (ANVISA) published crucial updates that laid the foundation for more harmonized and science-based oversight. With 2025 shaping up to be a transformative year, stakeholders in the life sciences sector need to stay informed and proactive.

2024: Strengthening regulatory foundations

RDC 875/2024: Improvements in the biosimilars pathway

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

  • Exemption from certain non-clinical and clinical studies when scientifically justified
  • Use of international reference products approved by Authorities Recognized as Equivalent (AREEs) when local comparators are not available and provided that they are manufactured by the same manufacturers of the medicine registered in Brazil or that they have carried out bridging studies if it is not possible to demonstrate that the manufacturers are the same.
  • Alignment with global guidelines such as WHO and ICH

This rule is in effect since June 17, 2024.

RDC 876/2024 amended by RDC 913/2024: Simplification of post-registration requirements

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

  • Clearer definitions of major and minor post-registration changes
  • Reduction of documentation requirements for specific categories
  • Reduced deadlines for ANVISA's assessment of post-registration changes

Introduction of new subject codes

In August 2024, ANVISA released 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
  • Soros hyperimmunes
  • Blood products and probiotics

Outlook for 2025: Key regulatory priorities

ANVISA’s 2024-2025 Regulatory Agenda places significant emphasis on modernizing and harmonizing Brazil’s biological product regulations. Below are the main focus areas for the year.

1. Review of the Technical Requirements for the Registration of Biological Products (RDC 55/2010)

ANVISA plans to review the technical and scientific requirements governing the registration of biological products. The planned changes include:

  • 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 with the aim of updating the criteria for registering biosimilar products.

2. Consolidation of Post-Registration Rules (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 act. Expected improvements include:

  • Consolidation of general aspects of the three existing regulations on post-registration of medicines relating to synthetic and semi-synthetic medicines (RDC 73/2016), herbal medicines and traditional herbal products (RDC 708/2022) and biological products (RDC 413/2022), maintaining the specificities of each category of medicine.
  • Standardized classification of post-registration changes
  • Consistent documentation templates for different types of updates
  • Centralized access to ANVISA's electronic portal for more efficient sending and tracking of information

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. Planned revisions include:

  • Contribute to the development of promising new technologies in the country's health sector
  • Defined review deadlines: ANVISA must respond to clinical trial requests within 90 business days, increasing predictability for sponsors
  • Parallel regulatory and ethical reviews
  • Enhanced participant protection.

4. Implementation of e-CTD

Discusses the best way to regulate e-CTD in Brazil, according to 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 medicinal products manufactured for human use throughout their life cycle. This review aims to:

  • harmonize the requirements related to the protocol, the documents necessary to identify the products and companies involved and, eventually, according to the assessment that is yet to be carried out, the definitions contained in the standards.
  • Guidelines for Good Assessment Practices will possibly also 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 post-registration and cancellation of biological products, which is in progress
  • This proposal seeks to modify Article 22 of the standard in order to optimize the process of modification protocols and their analysis by Anvisa.
  • This is expected to reduce the number of documents received and, therefore, reduce the analysis queues and administrative costs involved in similar analyses, without prejudice to the technical assessment carried out by GPBIO/GGBIO.
  • Additionally, as determined by DIRE2, the project must 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 medicines, 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 to evaluate prioritized petitions.
  • This topic has a major impact on the activities of these areas and also on public health.
  • It is important to review the marketing criteria, prioritization (Ex: new concentration of ibuprofen prioritized because it is a pediatric indication), definition of rare disease and granting of a commitment term.
  • Enable safe access to products and services essential to 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 promoted the Pharmaceutical Innovation Workshop with the aim of highlighting 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, effectiveness and quality of innovations.
  • It is also important to ensure a regulatory environment that is favorable to the creation and adoption of innovative technologies.
  • Contribute to the development of promising new technologies in the health sector in the country.

How companies can prepare

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

  • Align with ANVISA in advance through scientific advisory meetings and pre-submission consultations
  • Update regulatory dossiers to reflect revised quality and clinical data expectations
  • Leverage international benchmark products and regulatory trust pathways to reduce development timelines
  • Strengthen post-registration planning, especially for post-registration changes and renewals
  • Invest in preparation for submission, especially for digital formats and centralized electronic portals

Conclusion

The year 2025 marks a fundamental shift in Brazil’s regulatory landscape for biologics. With ANVISA’s focus on updated technical requirements, simplified 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-registration change management, and end-to-end regulatory guidance for clinical trials.

Contact us to align your strategy with Brazil's regulatory framework for 2025.

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