Investigation of common deficiencies observed in scientific assessments and the implementation of a new robust review pathway, the risk-based assessment approach, by the South African Health Regulatory Authority, SAHPRA
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Date
2022
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Western Cape
Abstract
The main objective of this study is to improve patient access to medicines. The research is two-fold, the
first component promotes transparency between the South African Health Products Regulatory
Authority (SAHPRA), pharmaceutical companies, manufacturers and clinical research organisations by
investigating deficiencies in scientific assessments of medicines submitted for approval. The common
deficiencies from the regional, Active Pharmaceutical Ingredient (API), Finished Pharmaceutical
Product (FPP) and Bioequivalence study sections of dossiers submitted to SAHPRA were qualitatively
and quantitatively investigated. The investigation was conducted retrospectively between 2011 to 2017
for non-sterile and sterile generic products finalised by the P&A pre-registration Unit. To strengthen
the conclusions, up-to-date data was also collected between 2020-2021 to confirm the consistency of
the findings.
Description
Doctor Pharmaceuticae - DPharm
Keywords
South African Health Products Regulatory Authority (SAHPRA), Pharmaceuticals, Biostudies, Public health, Bioequivalence studies