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Browsing by Author "Mahlangu, Gugu"
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Comparison of the registration process of the Medicines Control Authority of Zimbabwe with Australia, Canada, Singapore, and Switzerland: Benchmarking best practices
Sithole, Tariro; Salek, Sam; Mahlangu, Gugu; Walker, Stuart (2021-10-20)Background: 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 ... -
Evaluation of the Good Review Practices of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
Sithole, Tariro; Mahlangu, Gugu; Capote, Velma; Sitoie, Tania; Shifotoka, Saren; Gaeseb, Johannes; Padayachee, Silverani; Sehloho, Tohlang; Khea, Akida; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: National medicines regulatory agencies are faced with challenges including limited resources and technical capacity, resulting in countries collaborating and sharing resources to improve efficiency of the ... -
Evaluation of the Review Models and Approval Timelines of Countries Participating in the Southern African Development Community: Alignment and Strategies for Moving Forward
Sithole, Tariro; Mahlangu, Gugu; Capote, Velma; Sitoie, Tania; Shifotoka, Saren; Gaeseb, Johannes; Danks, Lorraine; Nkambule, Portia; Juma, Alex; Fimbo, Adam; Munkombwe, Zuma; Mwale, Bernice; Salek, Sam; Walker, Stuart (2021-08-27)Introduction: 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 ... -
Pharmaceutical Industry Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: The common technical document (CTD) format harmonised the requirements for the registration of medicines, which had traditionally differed from country to country, making it possible for countries to collaborate ... -
Regulatory Authority Evaluation of the Effectiveness and Efficiency of the ZaZiBoNa Collaborative Medicines Registration Initiative: The Way Forward
Sithole, Tariro; Mahlangu, Gugu; Walker, Stuart; Salek, Sam (2022-04-25)Introduction: ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall ...