Situation analysis on the regulation of nanomedicines in Southern Africa
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Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
Frontiers Media
Abstract
Medical 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.
Description
Keywords
Nanomedicines, African Medicines Agency, Pharmaceutics, Southern African Development Community, Covid-19, Public health
Citation
Mudyiwenyama, 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.2023.1098830