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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dc.contributor.advisorJoubert, Jacques
dc.contributor.authorMoeti, Lerato Petunia
dc.date.accessioned2023-05-25T09:49:07Z
dc.date.accessioned2024-05-15T07:16:48Z
dc.date.available2023-05-25T09:49:07Z
dc.date.available2024-05-15T07:16:48Z
dc.date.issued2022
dc.descriptionDoctor Pharmaceuticae - DPharmen_US
dc.description.abstractThe 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.en_US
dc.identifier.urihttps://hdl.handle.net/10566/15047
dc.language.isoenen_US
dc.publisherUniversity of the Western Capeen_US
dc.rights.holderUniversity of the Western Capeen_US
dc.subjectSouth African Health Products Regulatory Authority (SAHPRA)en_US
dc.subjectPharmaceuticalsen_US
dc.subjectBiostudiesen_US
dc.subjectPublic healthen_US
dc.subjectBioequivalence studiesen_US
dc.titleInvestigation 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, SAHPRAen_US

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