Registering New Drugs for Low-Income Countries: The African Challenge

What is the best strategy to approve novel drugs for disease such as sleeping sickness that predominantly affect patients in Africa? How can African regulators best be supported to evaluate these drugs for their own populations? For many years, African medicines regulatory authorities (MRAs) have relied on stringent regulators in developed countries to assess novel pharmaceutical products such as drugs and vaccines for use in African populations. However, a recent shift in the drug product environment for Africa has put this approach under strain. A score of new products are now being, or have been, developed specifically for diseases of the developing world (Table 1), creating new challenges for regulators in Africa and elsewhere. However, it is not at all certain that African regulatory authorities currently have the capacity to meet these new demands. A study conducted by the World Health Organization (WHO) in 2010 concluded that 90% of MRAs in subSaharan Africa ‘‘were in a situation which did not allow them to adequately carry out regulatory functions,’’ and thus could not guarantee the safety and efficacy of medicines to be used in their country [1– 3]. While undoubtedly improving, growth in African regulatory capacity is not keeping up with these new challenges. The growing demand to assess novel neglected disease (ND) products for African use has generated a range of responses from policymakers and product developers, as outlined below. While each approach offers unique benefits, none is ideally suited as a primary vehicle for drug registration for Africa. There is also no guidance to product developers in choosing between approaches, and little or no integration between approval mechanisms (see Figure 1). It is now critical to review how novel ND drugs are assessed and approved for African use. This article is based on research conducted for a report titled ‘‘Registering New Drugs: The African Context’’ [4], commissioned by the Drugs for Neglected Diseases initiative (DNDi), and builds upon this work with additional research and analysis.