Additional regulatory review pathways can facilitate faster dossier approvals in South Africa
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Date
2019
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Western Cape
Abstract
The objective of the study was to perform a comparative review of pathways, timelines and improvements of countries with markets that the South African Health Products Authority (SAHPRA) benchmark themselves against. Furthermore, this study intends to identify the factors that improved and accelerated submissions and approval process in investigated countries and potential introduction of these strategies into the South African market.
Description
Magister Pharmaceuticae - MPharm
Keywords
Regulatory, Facilitated, Harmonisation, Transparency, Accelerated