A recent shift in the drug product environment for Africa has seen a score of new products being developed specifically for diseases of the developing world, creating new challenges for regulators in Africa and elsewhere – reliance on developed-country regulatory systems may not be suitable. However, it is not at all certain that African regulatory authorities currently have the capacity to meet these new demands. The growing demand to assess novel neglected disease (ND) products for African use has generated a range of responses from policymakers and product developers, but there is limited guidance for product developers in choosing between approaches, and little or no integration between approval mechanisms. This article discusses the various mechanisms by which novel ND drugs are assessed and approved for developing country use, and makes six recommendations to create an efficient integrated system of national, regional, and international approvals to achieve an optimal drug registration approach for Africa that can reliably evaluate safety, efficacy, and quality of drugs for African use.
PLoS Medicine (2011) 8 (2): e1000411 [doi:10.1371/journal.pmed.1000411].
Registering New Drugs for Low-Income Countries: The African Challenge.