What's in the proposal
Public Consultation No. 1.362/2025 opened for public discussion a set of changes to the regulatory framework of Quality Systems applicable to sectors regulated by ANVISA:
- Pharmaceuticals
- Medical devices
- Cosmetics
- Sanitizers
- Food (in interface with health surveillance)
What ANVISA is
The Brazilian Health Regulatory Agency is the FDA-equivalent for Brazil — regulating quality systems for all health-related products sold in the country.
Why this matters internationally
The reform proposes aligning Brazil with practices of ICH (International Council for Harmonisation), PIC/S and ISO 13485 — facilitating export and reducing rework for companies operating in multiple countries.
This is significant for companies that:
- Already operate under FDA cGMP, EU GMP, or PIC/S
- Want to export from Brazil to regulated markets
- Want to import to Brazil from countries with mature quality systems
Pillars of the New Era
- Risk management as the backbone — ICH Q9 applied across the entire lifecycle
- Pharmaceutical quality system structured per ICH Q10
- Product and process knowledge documented and updated
- Process validation based on science, not number of lots
- Supplier qualification with formal requirements
- Change management with risk assessment before implementation
- CAPA (Corrective and Preventive Action) integrated with continuous improvement
What changes in practice
- Internal audits more rigorous and documented
- Quality indicators with goals and monthly monitoring
- Management Review formal and periodic
- Electronic audit trails in systems
- Continuous training — not just initial onboarding
For exporters, the reform is good news: it harmonizes requirements with markets like the EU, USA and Mercosur. For the domestic market, it raises the bar — companies operating at the minimum will need to invest more in quality.
Expected timeline
The public consultation goes through analysis of contributions and then becomes an RDC. Typically:
- Closing of the CP with consolidation of contributions
- Technical analysis by ANVISA — can take months
- Publication of the RDC with transition period (generally 12-24 months)
- Full vigency after the transition deadline
How your company can prepare
- Diagnosis of current system vs. the New Era pillars
- Adaptation plan with timeline and responsible parties
- Investment in qualification — quality team, electronic system, validation
- Active monitoring of the public consultation — submitting contributions is a right (and strategy)
- Benchmark with global manufacturers already operating under ICH Q9/Q10
Companies that anticipate gain competitive advantage both in export and in relationship with enforcement.