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Pharmaceutical Regulations in Brazil: ANVISA's New Normative Ruling No. 289/2024

Brazil's pharmaceutical industry is set to undergo a significant transformation with the recent approval of Normative Ruling No. 289/2024 by the National Health Surveillance Agency (ANVISA). This landmark regulation, approved on March 19, 2024 and published on 25th March 2024, aims to expedite the registration process for medicines, vaccines, and biological products and Active Pharmaceutical Ingredients in the country.

Pharmaceutical Regulations Brazil ANVISA 289/2024

To validate the viability of this approach, ANVISA introduced Collegiate Board Resolution (RDC) No. 750/2022 in September 2022, establishing a temporary optimized analysis procedure conducted by AREEs for a limited period. Following a thorough consultation process (CP) No. 1.108/2022, which garnered valuable feedback from industry stakeholders, ANVISA proceeded with the development of the definitive standard. Notably, the finalized instruction emphasizes that regardless of the chosen analysis route—optimized or ordinary—companies must adhere to stringent regulatory requirements and provide comprehensive documentation to support product safety and efficacy claims. This instruction marks a pivotal step towards fostering regulatory alignment and expediting market access for pharmaceutical products in Brazil.

Effective from April 1, 2024, ANVISA will be empowered to analyze and approve registrations more efficiently and at a reduced cost for products that have obtained approval from AREEs. Notably, Normative Ruling No. 289/2024 signifies a significant step forward in aligning Brazil's regulatory framework with international standards and best practices. The regulatory reliance program introduced by ANVISA represents a shift towards a more streamlined and efficient approval process. Under this program, pharmaceutical manufacturers can leverage approvals obtained from foreign regulatory authorities to expedite the registration of their products in Brazil. By accepting assessments conducted by equivalent foreign regulatory authorities, ANVISA aims to reduce duplication of efforts and regulatory burdens, ultimately benefiting both industry stakeholders and consumers.

The primary objective of Normative Ruling No. 289/2024 is to introduce criteria for the admission of assessments issued by equivalent foreign regulatory authorities (referred to as AREEs in Brazil). By recognizing assessments conducted by these foreign regulatory bodies, ANVISA seeks to accelerate the approval process for pharmaceutical products that have already been authorized by reliable agencies abroad. These agencies have been deemed equivalent to ANVISA in terms of their regulatory standards and practices.This includes agencies -

  • European Medicines Agency (EMA)

  • U.S. Food and Drug Administration (FDA)

  • World Health Organization (WHO)

  • Therapeutic Goods Administration (TGA) - Australia

  • Canadian Health Agency (Health Canada)

  • European Directorate for the Quality of Medicines and HealthCare (EDQM)

  • Swiss Agency for Therapeutic Products (Swissmedic)

  • Medicines and Healthcare products Regulatory Agency (MHRA) - United Kingdom


Pharmaceutical Regulations Brazil ANVISA 289/2024

Registration under Pharmaceutical Regulations in Brazil : ANVISA Normative 289/2024

To take advantage of the regulatory reliance program offered by ANVISA, pharmaceutical companies must ensure that their registration applications meet specific requirements. These include the complete submission of required documents, compliance with Brazilian legislation, and demonstration of equivalence between the product approved by AREEs and the one submitted to ANVISA. The documentation must ensure that it reflects the comprehensive authorization process and is devoid of any omissions. Compliance with current Brazilian legislation is non-negotiable. The manufacturing facilities must possess a Good Manufacturing Practices (GMP) Certificate to guarantee adherence to quality standards, while expiry dates must mirror those accepted by the AREE. These meticulous requirements underscore ANVISA's commitment to upholding safety, efficacy, and regulatory standards in the pharmaceutical industry. By fulfilling these criteria, manufacturers can expedite the approval process and bring their products to market more efficiently.

 Normative Ruling No. 289/2024 is the culmination of a collaborative effort between ANVISA and international regulatory authorities to harmonize regulatory processes and enhance public health outcomes. By recognizing assessments conducted by equivalent foreign regulatory authorities, ANVISA aims to leverage existing expertise and resources to expedite the approval of pharmaceutical products while maintaining stringent safety and efficacy standards.

 The implementation of Normative Ruling No. 289/2024 represents a significant milestone in Brazil's pharmaceutical regulatory landscape. This innovative approach to regulatory reliance is poised to drive innovation, foster international collaboration, and improve access to safe and effective pharmaceutical products for the Brazilian population.

 Artixio: Your Partner in Regulatory Compliance

 Navigating Brazil's complex pharmaceutical regulatory landscape requires expertise and knowledge of local requirements. At Artixio, we specialize in regulatory affairs and can help streamline the registration process for your pharmaceutical products in Brazil. Our team of experts will ensure that your submissions meet all ANVISA requirements, allowing you to navigate the regulatory process with confidence.

With Artixio by your side, you can leverage our experience and industry insights to expedite approvals, minimize delays, and ensure compliance with regulatory standards. Partner with Artixio today and unlock the full potential of Brazil's pharmaceutical market. Contact us to learn more about how we can support your regulatory journey in Brazil and beyond.

 Normative Ruling No. 289/2024 represents a significant step forward in Brazil's efforts to streamline pharmaceutical regulations and enhance access to safe and effective medicines. By recognizing assessments conducted by equivalent foreign regulatory authorities, ANVISA is paving the way for a more efficient and transparent approval process. With the support of regulatory experts like Artixio, pharmaceutical companies can navigate these changes successfully and bring innovative treatments to market more quickly, benefiting patients and public health in Brazil and beyond.

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