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South America

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- 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
- Urgent Procedure for biotechnological medicinal products

Copyright © The Erudee Foundation - All Rights Reserved. FRPath® and FRPanorama (TM) are marks of the Erudee Foundation. The information provided in FRPath® is derived from public documents, guidelines, scientific publications, and other reliable sources. The information so obtained is believed to be accurate; however, because the field changes rapidly, the user is encouraged to validate the information provided herein.