FRPath | South America Region FRPs

- Fast Track Proceedings: ‘Article 3’
- Fast Track Proceedings: ‘Article 4’
- Registrations Under Special Conditions

- Sanitary Emergency Law

- Resolução de Diretoria Colegiada (RDC) 204/2017—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
- Optimized Analysis Procedure
- Optimized Analysis Procedure (NORMATIVE INSTRUCTION - IN NO. 289, OF MARCH 20, 2024)

- 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)
- Procedure for Pharmacological and Pharmaceutical Evaluations of Biological Drugs in the Sanitary Registration Process (Decreee 1782 de 2014)

- Health Drug Registration for Homologation

- Simplified procedure (Law 1119/97)

- 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

Paraguay

Peru

Suriname

Uruguay