Brazilian National Health Surveillance Agency approves normative ruling for admitting assessments by foreign authorities

With the purpose of expediting the registration process of medicines, vaccines and biological products in Brazil, the National Health Surveillance Agency (Anvisa) approved, on March 19, 2024, Normative Ruling No. 289/2024, which establishes criteria for the admittance of assessments issued by equivalent foreign regulatory authorities (so called AREEs in Brazil).

Therefore, from April 1, 2024, Anvisa will be able to analyze and approve quicker and at a lower cost the registration of products that have already been approved by reference agencies abroad, such as the EMA (Europe), FDA (United States) and WHO. This regulation covers from medicines to vaccines, biological products and IFAs – Active Pharmaceutical Ingredients.

Such Normative Ruling considers the following foreign agencies as equivalent:

• European Medicines Agency (EMA)
• Canadian Health Agency (Health Canada)
• World Health Organization (WHO)
• 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
• U.S. Food and Drug Administration (FDA)
• Therapeutic Goods Administration (TGA) – Australia

To take advantage from the reliance route, which means, the approval already carried out by an equivalent foreign authority, the product registration application must meet the following requirements: (i) complete submission of the required documents; (ii) compliance with current Brazilian legislation; and (iii) demonstration of equivalence between the product approved by AREE and the one submitted to Anvisa.

The Normative Ruling is the result of a process that began in mid-2022 and is part of a cooperation between Anvisa and international regulatory authorities aiming at maximizing benefits for people and ensuring safety and security effectiveness of regulated products.

This is an important measure to assist the development of the sector and public health in Brazil.

This bulletin is for information purposes only and should not be relied upon to obtain legal advice on any of the topics dealt with here. For additional information, please contact the leaders of the Corporate team.

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