(University of the Western Cape, 2021) Dhanraj, Keshnee; Dube, Admire; Ward, Kim
Medicines have to be regulated in an effort to monitor their quality, safety, and efficacy. The
process of medicines registration is lengthy, costly, and document-heavy. Many countries have
limited expertise and resources at national medicines regulatory authorities (NMRAs) and
some countries have adopted unified approaches to medicines registration legislation.
Harmonised guidelines and initiatives have been adopted in South Africa and the Southern
African Development Community (SADC). However, there are no studies that have identified
the effects of these initiatives and guidelines on major stakeholders such as the pharmaceutical
industry and regulators.