South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

• Main Authors: Andrea Keyter (Author), Sam Salek (Author), Lorraine Danks (Author), Portia Nkambule (Author), Boitumelo Semete-Makokotlela (Author), Stuart Walker (Author)
• Format: Book
• Published: Frontiers Media S.A., 2021-07-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Background: The aims of this study were to compare the overall regulatory review timelines achieved by the South African Health Products Regulatory Authority (SAHPRA) in 2020 to the timelines historically achieved by the Medicines Control Council (MCC). This study also aimed to evaluate the regulato...