The implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)

dc.contributor.authorMoeti, Lerato
dc.contributor.authorLitedu, Madira
dc.contributor.authorJoubert, Jacques
dc.date.accessioned2023-01-30T07:44:40Z
dc.date.available2023-01-30T07:44:40Z
dc.date.issued2023
dc.description.abstractAn 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.en_US
dc.identifier.citationMoeti, 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-wen_US
dc.identifier.issn1179-1993
dc.identifier.urihttps://doi.org/10.1007/s40290-022-00452-w
dc.identifier.urihttp://hdl.handle.net/10566/8318
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.subjectSouth African Health Products Regulatory Authority (SAHPRA)en_US
dc.subjectPharmacyen_US
dc.subjectSouth Africaen_US
dc.subjectMedicinal plantsen_US
dc.subjectWorld Health Organization (WHO)en_US
dc.titleThe implementation of a risk based assessment approach by the South African Health pProducts Regulatory Authority (SAHPRA)en_US
dc.typeArticleen_US

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