Show simple item record

dc.contributor.authorSithole, Tariro
dc.contributor.authorMahlangu, Gugu
dc.contributor.authorCapote, Velma
dc.contributor.authorSitoie, Tania
dc.contributor.authorShifotoka, Saren
dc.contributor.authorGaeseb, Johannes
dc.contributor.authorDanks, Lorraine
dc.contributor.authorNkambule, Portia
dc.contributor.authorJuma, Alex
dc.contributor.authorFimbo, Adam
dc.contributor.authorMunkombwe, Zuma
dc.contributor.authorMwale, Bernice
dc.contributor.authorSalek, Sam
dc.contributor.authorWalker, Stuart
dc.date.accessioned2021-09-22T12:48:54Z
dc.date.available2021-09-22T12:48:54Z
dc.date.issued2021-08-27
dc.identifier.citationSithole , T , Mahlangu , G , Capote , V , Sitoie , T , Shifotoka , S , Gaeseb , J , Danks , L , Nkambule , P , Juma , A , Fimbo , A , Munkombwe , Z , Mwale , B , Salek , S & Walker , S 2021 , ' Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward ' , Frontiers in Medicine , vol. 8 , 742200 . https://doi.org/10.3389/fmed.2021.742200
dc.identifier.issn2296-858X
dc.identifier.otherPURE: 25974076
dc.identifier.otherPURE UUID: 2e15e0a1-125f-4740-ba26-c83dede65194
dc.identifier.otherJisc: ad5305436de647fc93fa0fd5a3421d1f
dc.identifier.otherScopus: 85114725663
dc.identifier.urihttp://hdl.handle.net/2299/25073
dc.description.abstractIntroduction: Regulatory reliance, harmonization and work sharing have grown over the last few years, resulting in greater sharing of work and information among regulators, enabling efficient use of limited resources and preventing duplication of work. Various initiatives on the African continent include ZaZiBoNa, the Southern African Development Community (SADC) collaborative medicines registration initiative. ZaZiBoNa has resulted in great savings in time and resources; however, identified challenges include lack of clear information regarding the participating countries registration processes and requirements as well as lengthy registration times. The aim of this study, therefore, was to compare the data requirements and review models employed in the assessment of applications for registration, the target timelines for key milestones and the metrics of applications received and approved in 2019 and 2020 by Mozambique, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe. Methods: A senior member of the division responsible for issuing marketing authorisations completed an established and validated questionnaire, which standardizes the review process, allowing key milestones, activities and practices of the six regulatory authorities to be identified and compared. The completed questionnaires were validated by the heads of the respective agencies. Results: The majority of applications received and approved by all six agencies in 2019 and 2020 were for generics. The mean approval times for generics varied across the countries, with ranges of 218–890 calendar days in 2019 and 158–696 calendar days in 2020. All three types of scientific assessment review models were used by the six agencies and data requirements and extent of scientific assessment were similar for five countries, while one conducted full reviews for new active substances. A large variation was observed in the targets set by the six agencies for the different milestones as well as overall approval times. Conclusions: The study identified the strengths of the countries as well as opportunities for improvement and alignment. Implementation of the recommendations made as in this study will enhance the countries' individual systems, enabling them to efficiently support the ZaZiBoNa initiative.en
dc.language.isoeng
dc.relation.ispartofFrontiers in Medicine
dc.subjectMedicine
dc.subjectSouth African Development Community
dc.subjectZaZiBoNa
dc.subjectregulatory reliance
dc.subjectregulatory review models
dc.subjectregulatory approval timelines
dc.titleEvaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forwarden
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
rioxxterms.versionVoR
rioxxterms.versionofrecordhttps://doi.org/10.3389/fmed.2021.742200
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record