🇧🇷Agência Nacional de Vigilância Sanitária

ANVISA NAMs Framework

Brazil's ANVISA is developing NAMs framework aligned with ICH guidelines and FDA cooperation, targeting formal acceptance by 2026.

ICH
Observer
FDA
Cooperation
2026
Target
CONCEA
3Rs Body
Written by J Radler | Patient Analog
Last updated: January 2025

Regulatory Highlights

  • Current regulatory framework and acceptance pathways
  • Compliance requirements for NAMs submissions
  • International harmonization through ICH guidelines
  • Practical guidance for regulatory strategy

Brazil's NAMs Development

ANVISA is working toward formal NAMs acceptance, leveraging Brazil's growing biotech sector and international regulatory cooperation agreements.

CONCEA 3Rs Framework

The National Council for the Control of Animal Experimentation (CONCEA) promotes 3Rs principles:

  • Legal Mandate: Brazilian law requires 3Rs consideration
  • BraCVAM: Brazilian Center for Validation of Alternative Methods
  • Training Programs: Building NAMs expertise nationally

International Cooperation

  • FDA Collaboration: Information sharing agreement active
  • ICH Observer: Participating in guideline development
  • MERCOSUR: Regional harmonization efforts