What is AREE in Brazil?

In Brazil, the term Autoridade Reguladora Estrangeira Equivalente (AREE), or Equivalent Foreign Regulatory Authority, has gained significant prominence in the realm of health product approvals. Recently introduced by the Agência Nacional de Vigilância Sanitária (ANVISA), or the Brazilian Health Regulatory Agency, AREE refers to Regulatory bodies from other countries whose assessments of drugs, vaccines, biological products, and medical devices are considered equivalent to those conducted by ANVISA itself. AREE was conceptualized through two (02) key instructions issued by ANVISA in March 2024:

  • Instruction No. 289/2024
  • Instruction No. 290/2024

These instructions aim to streamline the approval process for health products that have already been authorized by designated AREEs in their respective countries. This initiative is part of ANVISA’s broader effort to harmonize and expedite the assessment procedures while maintaining rigorous standards of safety, efficacy, and quality. To qualify as an AREE, a foreign Regulatory authority must meet specific criteria set by ANVISA, which include:

  • Conducting both pre-market and post-market Regulatory activities in a manner consistent with ANVISA’s standards.
  • Adherence to international norms endorsed by prominent bodies such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO).

The list of approved AREEs includes globally recognized agencies like the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), Health Canada (HC), and other similar bodies that have demonstrated their capacity to ensure the safety and efficacy of health products through stringent Regulatory processes.

For manufacturers seeking approval in Brazil, utilizing the streamlined AREE assessment process involves submitting specific documentation to ANVISA, including proof of the product’s approval by the relevant AREE and compliance with ANVISA’s requirements. This approach allows for a faster evaluation of health product registrations, as compared to the standard process; however, ANVISA retains the discretion to conduct a comprehensive analysis, if deemed necessary.

While the streamlined AREE assessment offers efficiency, it does not in any way compromise the thoroughness of ANVISA’s Regulatory oversight. The agency reserves the right to reassess any product through its standard procedures at any stage, thereby ensuring ongoing compliance with evolving health and safety standards.

To sum up, the introduction of AREEs in Brazil marks a significant step towards international Regulatory alignment and efficiency in health product approvals. By recognizing assessments from trusted foreign authorities, ANVISA not only facilitates faster market access for manufacturers, but also strengthens Brazil’s position in global health product regulation, promoting public health while supporting innovation in the life sciences sector.

Are you eyeing the Brazilian market for your health products? Stay ahead with Freyr, your gateway to understanding and navigating ANVISA’s latest regulations. Our experts specialize in deciphering the intricacies of Instruction No. 289/2024 and Instruction No. 290/2024, ensuring seamless compliance and swift approvals. Tap into our deep industry knowledge and experience to accelerate your entry into Brazil's dynamic healthcare sector. Contact us today and unlock your pathway to success in the Brazilian market!

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