Acesso Ampliado (Expanded Access)
BR-unique
Acesso Ampliado (Expanded Access) is a Brazilian regulatory mechanism that allows broader patient access to devices (and drugs) that are still in clinical development or not yet fully registered, but have demonstrated sufficient evidence of safety and efficacy.
Difference between Uso Compassivo and Acesso Ampliado
| Feature | Uso Compassivo | Acesso Ampliado |
|---|---|---|
| Scope | Individual patient | Multiple patients / patient group |
| Stage | Device not yet in clinical trial or registration | Device in clinical trial phase or post-trial |
| Basis | Compassionate need — no alternative | Promising evidence from trials |
| Duration | Case by case | Program-level authorisation |
Process
Acesso Ampliado requires a formal application to ANVISA demonstrating:
- Evidence of promising safety and efficacy;
- Absence of adequate registered alternatives;
- Protocol for patient monitoring and adverse event reporting; and
- Ethics committee (CEP) approval.
ANVISA may set conditions on the Acesso Ampliado authorisation, including mandatory adverse event reporting and periodic progress reports.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.