FRPath | South America Region FRPs

- Fast Track Proceedings: ‘Article 3’
- Fast Track Proceedings: ‘Article 4’

- Sanitary Emergency Law

- ANVISA Priority Review
- Biologics and Biosimilars Pathway (OS-45)
- Temporary authorization for emergency use of medication for COVID-19
- Orphan Drug Route
- Abridged Review for Small Molecules

- Simplified Procedure (Procedimiento Simplificado de Registro)
- Priority Review: Short Registration Procedure
- Sanitary Registration of Orphan Medicines
- Decree 54 Abbrv Reliance

- INVIMA Abbreviated Procedure (Article 27)
- INVIMA Exceptional Circumstances (Decree 481)
- Emergency Use Authorization (ASUE)

- Health Drug Registration for Homologation

- Reliance Pathway
- Conditional Sanitary Registration of Medicines and Biological Products

- TBD

- Expedited Procedure

South America

Choose a country below to begin

Argentina

Bolivia

Brazil

Chile

Colombia

Ecuador

Peru

Suriname

Uruguay