Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa

BACKGROUND: This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an abridged review process in South Africa based on good re...

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Detalles Bibliográficos
Autores principales: Keyter, Andrea, Salek, Sam, McAuslane, Neil, Banoo, Shabir, Azatyan, Samvel, Walker, Stuart
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458939/
https://www.ncbi.nlm.nih.gov/pubmed/32865802
http://dx.doi.org/10.1007/s43441-020-00144-0

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458939/
https://www.ncbi.nlm.nih.gov/pubmed/32865802
http://dx.doi.org/10.1007/s43441-020-00144-0

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