The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges
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Date
2023
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Frontiers Media
Abstract
In 2016, the African Union (AU) Model Law on Medical Products
Regulation was endorsed by AU Heads of State and Government. The aims of the
legislation include harmonisation of regulatory systems, increasing collaboration
across countries, and providing a conducive regulatory environment for medical
product/health technology development and scale-up. A target was set to have
at least 25 African countries domesticating the model law by 2020. However,
this target has not yet been met. This research aimed to apply the Consolidated
Framework for Implementation Research (CFIR) in analysing the rationale, perceived
benefits, enabling factors, and challenges of AU Model Law domestication and
implementation by AU Member States.
Description
Keywords
Pharmaceutical policy, African medicines, Legislation, Medical health, African Union
Citation
Ncube, B. M. et al. (2023). The domestication of the African Union model law on medical products regulation: Perceived benefits, enabling factors, and challenges. Frontiers in Medicine, 10, 1117439. https://doi.org/10.3389/fmed.2023.1117439