Situation analysis on the regulation of nanomedicines in Southern Africa

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dc.contributor.authorMudyiwenyama, Linda G.
dc.contributor.authorKhoza, Star
dc.contributor.authorDube, Admire
dc.date.accessioned2023-05-30T12:25:35Z
dc.date.available2023-05-30T12:25:35Z
dc.date.issued2023
dc.description.abstractMedical products incorporating nanoparticle drug delivery systems (nanomedicines) are therapeutic or imaging agents, which comprise a delivery system within the nanometer size range (1 – 1000 nm). As medical products, nanomedicines meet definitions of medicines according to various national legislations for regulation of medicines. However, for the regulation of nanomedicines, additional assessments including toxicological issues have to be considered. These complexities require extra regulatory effort. In the resourcelimited context of low- and middle-income countries, many National Medicines Regulatory Authorities (NMRAs) lack resources and capacities to effectively assure the quality of medicinal products in their countries. With emerging trends in innovative technologies, including nanotechnology, this burden is worsened. The need to overcome regulatory challenges drove the formation of a work sharing initiative in the Southern African Development Community (SADC), ZaZiBoNA in 2013. Regulatory agencies participating in this initiative cooperate in the assessment of applications for registration of medicines.en_US
dc.identifier.citationMudyiwenyama, L. G. et al. (2023). Situation analysis on the regulation of nanomedicines in Southern Africa. Frontiers in Medicine, 10, 1098830. https://doi.org/10.3389/fmed.2023.1098830en_US
dc.identifier.issn2296-858X
dc.identifier.urihttps://doi.org/10.3389/fmed.2023.1098830
dc.identifier.urihttp://hdl.handle.net/10566/8967
dc.language.isoenen_US
dc.publisherFrontiers Mediaen_US
dc.subjectNanomedicinesen_US
dc.subjectAfrican Medicines Agencyen_US
dc.subjectPharmaceuticsen_US
dc.subjectSouthern African Development Communityen_US
dc.subjectCovid-19en_US
dc.subjectPublic healthen_US
dc.titleSituation analysis on the regulation of nanomedicines in Southern Africaen_US
dc.typeArticleen_US

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