Registering New Drugs for Low-Income Countries: The African Challenge
(2011; 6 pages)


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...

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