Anvisa Approval of Foreign Regulatory Assessments

During its public Collegiate Board meeting on March 19, 2024, Anvisa approved an instructional norm aimed at establishing criteria for the use of assessments from foreign equivalent regulatory authorities within its framework. This recent Anvisa approval represents a significant milestone in the regulatory processes for drugs, vaccines, biological products and pharmaceutical inputs in Brazil.

The newly approved measure applies to both registration and post-registration analyses of drugs, vaccines and biological products, including the Letter of Suitability of the Active Pharmaceutical Ingredient (Cadifa). This standard, known as the Reliance Regulatory Framework, establishes a simplified process for products approved by foreign regulatory authorities with regulations and practices equivalent to those of Anvisa.

The foreign equivalent regulatory authorities covered by this measure include prominent regulatory bodies such as:

  • European Medicines Agency (EMA),
  • Health Canada,
  • World Health Organization (WHO),
  • European Directorate for the Quality of Medicines & HealthCare (EDQM),
  • Swissmedic,
  • Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom,
  • US Food and Drug Administration (FDA)
  • the Therapeutic Goods Administration (TGA) in Australia.

Principles for Using the Reliance Pathway

The criteria set forth in the guidance standard are based on principles designed to ensure the integrity and effectiveness of the regulatory process. This includes complete submission of required documentation, compliance with applicable Brazilian legislation, and demonstration of equivalence between products approved by foreign regulatory authorities and those under evaluation by Anvisa.

Understanding the process leading to Anvisa approval

This regulatory progress is the result of a process conducted in several phases. First, with the approval of RDC 750/2022, a pilot phase was carried out from August 2022 to test and evaluate the feasibility of the new model, while gathering relevant information and experience.

Subsequently, public consultation 1,108 was held between October 15 and December 29, 2022, allowing stakeholders to participate and contribute to the refinement of the proposed criteria. The insights gathered during these phases were analyzed and consolidated to refine the normative text, culminating in its approval for implementation in 2024.

Throughout the process, Anvisa facilitated a series of interactions with stakeholders, including public meetings, the publication of explanatory technical documents, and responding to requests from all interested parties. In addition, the agency engaged in bilateral dialogues with various foreign regulators to share experiences and best practices.

The Anvisa approval of the standard for leveraging assessments from equivalent foreign authorities marks a significant milestone in streamlining regulatory processes for medicines, vaccines, biological products and pharmaceutical inputs. By embracing reliance regulatory frameworks, Anvisa not only promotes efficiency and transparency, but also contributes to global harmonization efforts to ensure the quality and safety of healthcare products for all.