ANVISA updates reliance authority list (IN No. 403/2025)

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Date: November 12, 2025

The ANVISA has updated its list of Equivalent Foreign Regulatory Authorities (AREEs) through the publication of Normative Instruction (IN) No. 403/2025.

This list is used within ANVISA’s Reliance framework, allowing the Brazilian authority to leverage prior assessments conducted by recognized foreign regulators for specific regulatory procedures.

What is the reliance process used for ?

The AREE list applies to regulatory reliance for:

  • Evaluation of the Letter of Adequacy of the Active Pharmaceutical Ingredient Dossier (CADIFA)
  • Review of registration and post-registration applications for:
    • Medicines
    • Biological products
    • Vaccines

This mechanism can streamline regulatory pathways by recognizing prior evaluations from trusted authorities.

NEW : PMDA Added to the List

The main change introduced by IN No. 403/2025 is the inclusion of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

PMDA is now recognized by ANVISA for:

  • APIs
  • Evaluation of medicines, biological products, and vaccines
  • Exclusively regarding product quality information

This addition strengthens regulatory alignment between Brazil and Japan and may facilitate strategic regulatory planning for Japanese-approved products.

Updated list of Equivalent Foreign Regulatory Authorities (AREEs)

Under IN No. 403/2025, the recognized authorities are:

  • European Medicines Agency (EMA) – centralized procedures for APIs, medicines, vaccines, and biological products
  • Health Canada – APIs, medicines, vaccines, and biological products
  • World Health Organization (WHO) – APIs, medicines, vaccines, and biological products
  • European Directorate for the Quality of Medicines & HealthCare (EDQM) – APIs (supporting documentation waived under Article 14, §2)
  • Swissmedic – medicines, vaccines, and biological products
  • Medicines and Healthcare products Regulatory Agency (MHRA) – medicines, vaccines, and biological products
  • U.S. Food and Drug Administration (FDA) – medicines, vaccines, and biological products
  • Therapeutic Goods Administration (TGA) – medicines, vaccines, and biological products
  • Pharmaceuticals and Medical Devices Agency (PMDA) – APIs and quality evaluation of medicines, biological products, and vaccines

Official ANVISA sources

ANVISA – Normative Instruction (IN) No. 403/2025

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