MERCOSUL Regulatory Roadmap
ANVISA and its MERCOSUL counterparts (ANMAT in Argentina, MSP in Uruguay, DINAVISA in Paraguay) are working towards greater regulatory harmonisation under the MERCOSUL framework. This page summarises the current state of harmonisation and the roadmap.
Current state of harmonisation (2026)
| Area | Current status |
|---|---|
| Classification framework | Harmonised — all MERCOSUL countries use the GMC Res. 40/2000 four-class framework |
| Registration systems | National — separate registrations required in each country |
| GMP requirements | Partially harmonised — GMC Res. 33/2006; ISO 13485 widely accepted |
| Adverse event reporting | Partially harmonised — GMC Res. 12/2014 |
| UDI | Not yet harmonised — each country at different stage |
| Clinical evidence | Not yet harmonised — national requirements apply |
The regulatory harmonisation roadmap
MERCOSUL's long-term goal is a mutual recognition arrangement where a regulatory approval in one MERCOSUL country is recognised by others — similar to how ASEAN AMDD works for Singapore, Malaysia, Thailand, and other members. Progress has been slow due to differences in regulatory capacity and political priorities.
Key milestones expected:
- Harmonised UDI system across MERCOSUL countries
- Mutual recognition of GMP inspections
- Closer alignment of clinical evidence requirements
Practical implications for manufacturers
Until full harmonisation is achieved, manufacturers must file separate registrations in each MERCOSUL country:
- Brazil → ANVISA
- Argentina → ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
- Uruguay → MSP (Ministerio de Salud Pública)
- Paraguay → DINAVISA (Dirección Nacional de Vigilancia Sanitaria)
Documentation prepared to ANVISA/GMC standards is reusable for ANMAT submissions with relatively minor adaptation.
Verify all information against official ANVISA sources before making regulatory decisions.