Expanded Access, Compassionate Use and Post-study Drug Supply Programs in Brazil
Reviewed Topics:
- Definitions
- Institutions Involved in the Process
- General Information
- Sponsor Responsibilities
- Physician Responsibilities
- Program Registration Process
- Expanded Access Program:
- Qualification Criteria
- Content of Application
- Compassionate Use Program
- Qualification Criteria
- Content of Application
- Post-Study Drug Supply Program
- Drug’ Importation
- Programs’ Monitoring
- Program’s Changes
- Appendices of RDC 38/2013
- Timelines and Fees
- Appendices of RDC 38/2013
- References
More Resources:
Brazil's ANVISA
In Brazil, the National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the regulatory agency that is responsible for the approval and supervision of medical devices, pharmaceuticals, cosmetics and health services among others.