The implementation of the African union model law on medical products regulation and the establishment of the African medicines agency
Loading...
Date
2022
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
University of the Western Cape
Abstract
Within Africa, there is insufficient access to quality, safe, efficacious and
affordable medical products which can partly be attributed to lack of robust
regulatory systems, a lack of competent regulatory professionals in national
medicines regulatory authorities (NMRAs) and ineffective regional
collaborations among NMRAs. In response to national regulatory challenges, a
number of regional harmonisation efforts were introduced through the African
Medicines Regulatory Harmonisation (AMRH) initiative to, among others,
expedite market authorisation of medical products and to facilitate the alignment
of national legislative frameworks with the African Union (AU) Model Law on
Medical Products Regulation.
Description
>Magister Scientiae - MSc
Keywords
Pharmaceutical policy, African Medicines Regulatory Harmonisation Initiative, Legislation, Africa, Medicine