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Anvisa's Normative Instruction (IN) 289/2024 establishes criteria for utilizing assessments conducted by Equivalent Foreign Regulatory Authorities (AREEs) to streamline the registration and post-registration processes for medicines, biological products, vaccines, and Active Pharmaceutical Ingredients (APIs) in Brazil.

Key Aspects of IN 289/2024:

  • Optimized Analysis Procedure: This procedure allows Anvisa to expedite the evaluation of products already approved by recognized foreign regulatory bodies, thereby reducing approval times and enhancing access to essential medicines.
  • Recognized AREEs: Anvisa acknowledges assessments from authorities such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), Health Canada, and the World Health Organization (WHO).
  • Scope of Application: The instruction applies to the registration and post-registration procedures for medicines, biological products, vaccines, and the issuance of the Active Pharmaceutical Ingredient Dossier (CADIFA).

Implications of IN 289/2024:

  • Enhanced Efficiency: By leveraging evaluations from trusted foreign authorities, Anvisa aims to reduce duplication of efforts and accelerate the availability of high-quality health products in the Brazilian market.
  • Regulatory Convergence: This initiative promotes alignment with international regulatory practices, fostering greater collaboration and information exchange between Anvisa and its foreign counterparts.
  • Improved Access: The streamlined processes are expected to facilitate quicker access for patients to innovative and essential medicines, enhancing public health outcomes.

IN 289/2024 reflects Anvisa's commitment to adopting global best practices in regulatory science, ensuring that safe and effective health products reach the Brazilian population more efficiently.

Are You Interested in Entering the Brazilian Market?  

Freyr can help you navigate Anvisa's new regulatory reliance procedure. Take advantage of our expertise to accelerate your market entry in Brazil, streamline your approval processes, and ensure compliance. Get in touch with us today!