Anvisa approves regulations on using analyses by Equivalent Foreign Regulatory Authorities (reliance)

On March 25, 2024, the Brazilian National Health Surveillance Agency (“ANVISA/DICOL”) published Normative Instruction No. 289/2024, that establishes criteria for the use of analyses carried out by an Equivalent Foreign Regulatory Authority (“AREE”).

This measure applies to the analysis of applications for registration and post-registration of medicines, biological products, vaccines and the letter of suitability of the active pharmaceutical ingredient (“CADIFA”) in Brazil. Also known as the Regulatory Reliance Program, the normative instruction introduces a simplified process for products that have been approved by foreign regulators with regulations and practices equivalent to those of ANVISA. The sector must welcome this approval, as it reduces the waiting period before ANVISA and seeks to achieve regulatory alignment.

To date, the official text of the normative instruction has not been published, except for the draft approved by DICOL.

Our Life Sciences team highlights below some of the main changes introduced by the new normative instruction.

What changes?

The general requirements for the optimized procedure had already been established by RDC No. 741/2022 (referred to as a “pilot project” by ANVISA), however, specific definitions of the technical eligibility criteria and the AREEs to be accepted by ANVISA were still pending. 

Thus, the regulatory reliability criteria established by the normative instruction are extremely important for the sector, making it possible to simplify the procedures for analyzing the registration and post-registration of products already authorized by important foreign authorities, such as the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”).

AREEs designated by ANVISA

In total, eight AREEs have been designated by Anvisa, but only the World Health Organization (“WHO”) analysis is suitable for all products – active pharmaceutical ingredients (“API”), medicines, vaccines and biological products. In addition, only the analysis by the WHO and the European Directorate for the Quality of Medicines and HealthCare (“EDQM”) are suitable for the optimized API procedure.

Assessing the eligibility of registration applications

The criteria established in the normative instruction are based on principles aimed at ensuring the integrity and effectiveness of regulatory processes. This includes:

• Submission of the required documents in full: the documentation submitted must relate to the definitive authorization process and must be complete. The application for approval of the product must preferably not have been denied in another country by one of the AREEs.
• Compliance with the current Brazilian legislation: the characteristics of the product submitted for analysis by ANVISA must be identical to the characteristics of the product approved by the AREE, the manufacturing establishments must have a Good Manufacturing Practices (“GMP”) Certificate, and the expiry dates must be identical to those accepted by the AREE.
• Demonstration of equivalence between products approved by foreign reference regulatory authorities and those submitted for analysis by ANVISA.

The new normative instruction is expected to enter into force on April 01, 2024.

Demarest’s Life Sciences team will monitor the updates of the industry and is available to provide any further clarifications that may be necessary.