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dc.contributor.authorSithole, Tariro
dc.contributor.authorSalek, Sam
dc.contributor.authorMahlangu, Gugu
dc.contributor.authorWalker, Stuart
dc.date.accessioned2022-01-12T11:45:02Z
dc.date.available2022-01-12T11:45:02Z
dc.date.issued2021-10-20
dc.identifier.citationSithole , T , Salek , S , Mahlangu , G & Walker , S 2021 , ' Comparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practices ' , Expert Review of Clinical Pharmacology . https://doi.org/10.1080/17512433.2022.1987883
dc.identifier.issn1751-2433
dc.identifier.otherPURE: 26086677
dc.identifier.otherPURE UUID: 86e77b00-00a3-4525-b377-011f76ae197d
dc.identifier.otherScopus: 85114715385
dc.identifier.urihttp://hdl.handle.net/2299/25299
dc.description© 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/).
dc.description.abstractBackground: Benchmarking regulatory systems of low- and middle-income countries with mature systems provides an opportunity to identify gaps, enhance review quality, and reduce registration timelines, thereby improving patients’ access to medicines. The aim of this study was to compare the medicines registration process of the Medicines Control Authority of Zimbabwe (MCAZ) with the regulatory processes in Australia, Canada, Singapore, and Switzerland. Methods: A questionnaire that standardizes the review process, allowing key milestones, activities and practices of the five regulatory authorities was completed by a senior member of the divisions responsible for issuing marketing authorizations. Results: The MCAZ has far fewer resources than the regulatory authorities in the comparator countries, but employs three review models, which is in line with international best practice. The MCAZ registration process is similar to the comparator countries in key milestones monitored, but differs in the target timelines for these milestones. The MCAZ is comparable to the comparator authorities in implementing the majority of good review practices, although it significantly lags behind in transparency and communication. Conclusion: This study identified the MCAZ strengths and opportunities for improvement, which if implemented, will enable the achievement of its vision to be a leading regulatory authority in Africa.en
dc.format.extent12
dc.language.isoeng
dc.relation.ispartofExpert Review of Clinical Pharmacology
dc.rightsOpen
dc.subjectMedicines Control Authority of Zimbabwe (MCAZ), international best-practice, improved medicines access, registration of medicines, low- and middle-income countries (LMIC)
dc.subjectMedicines Control Authority of Zimbabwe (MCAZ)
dc.subjectlow- and middle-income countries (LMIC)
dc.subjectimproved medicines access
dc.subjectinternational best-practice
dc.subjectregistration of medicines
dc.subjectMedicine(all)
dc.subjectPharmacology (medical)
dc.subjectPharmacology, Toxicology and Pharmaceutics(all)
dc.titleComparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practicesen
dc.contributor.institutionCentre for Health Services and Clinical Research
dc.contributor.institutionSchool of Life and Medical Sciences
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85114715385&partnerID=8YFLogxK
dc.relation.schoolSchool of Life and Medical Sciences
dc.description.versiontypeFinal Published version
dcterms.dateAccepted2021-10-20
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.1080/17512433.2022.1987883
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue
herts.rights.accesstypeOpen


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