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dc.contributor.authorKeyter, A
dc.contributor.authorGouws, J
dc.contributor.authorSalek, Mir-Saeed Shayegan
dc.contributor.authorWalker, S
dc.date.accessioned2018-11-21T12:38:51Z
dc.date.available2018-11-21T12:38:51Z
dc.date.issued2018-07-01
dc.identifier.citationKeyter , A , Gouws , J , Salek , M-S S & Walker , S 2018 , ' The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System. ' , Therapeutic Innovation & Regulatory Science , vol. 52 , no. 4 , pp. 449-458 . https://doi.org/10.1177/2168479018776649
dc.identifier.issn2168-4790
dc.identifier.otherPURE: 15427000
dc.identifier.otherPURE UUID: 55b89e3a-95d3-45d2-a986-356ca0d8acf1
dc.identifier.otherScopus: 85047914836
dc.identifier.urihttp://hdl.handle.net/2299/20812
dc.description.abstractBACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. METHODS: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). RESULTS: Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. CONCLUSIONS: As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.en
dc.format.extent10
dc.language.isoeng
dc.relation.ispartofTherapeutic Innovation & Regulatory Science
dc.rightsOpen
dc.subjectMedicine Control Council (MCC)
dc.subjectSouth Africa Health Products Regulatory Authority (SAHPRA)
dc.subjectbest practices
dc.subjectgood review practices
dc.subjectregulatory review
dc.subjectPharmacology, Toxicology and Pharmaceutics (miscellaneous)
dc.subjectPublic Health, Environmental and Occupational Health
dc.subjectPharmacology (medical)
dc.titleThe Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.en
dc.contributor.institutionDepartment of Pharmacy, Pharmacology and Postgraduate Medicine
dc.contributor.institutionPublic Health and Patient Safety Unit
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionSchool of Life and Medical Sciences
dc.contributor.institutionDepartment of Clinical and Pharmaceutical Sciences
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85047914836&partnerID=8YFLogxK
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Published version
dcterms.dateAccepted2018-07-01
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.1177/2168479018776649
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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