The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)
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Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
Springer
Abstract
An extensive backlog of pending regulatory decisions is one of the major historical challenges that the South
African Health Products Regulatory Authority (SAHPRA) inherited from the Medicine Control Council (MCC). Revising and
implementing new regulatory pathways is one of the strategic mechanisms that SAHPRA employs to circumvent this problem. To alleviate the backlog, the use of a new review pathway termed the risk-based review on the scientifc quality
and bioequivalence assessments was explored. The objective of the study was to articulate the risk-based assessment (RBA)
pathway, to determine robust criteria for the classifcation of the levels of risk for medicines, and to defne the improved
process to be followed in the assessment and approval of medicines.
Description
Keywords
South African Health Products Regulatory Authority (SAHPRA), Pharmacy, South Africa, Medicinal plants, World Health Organization (WHO)
Citation
Moeti, L. et al. (2023). The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA). Pharmaceutical Medicine, 37, 71–91. https://doi.org/10.1007/s40290-022-00452-w