Abstract
Registering New Drugs for Low-Income Countries: The African Challenge
Highlights
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
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 could not guarantee the safety and efficacy of medicines to be used in their country [1,2,3]
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
Summary
What is the best strategy to approve novel drugs for disease such as sleeping sickness that predominantly affect patients in Africa? 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. A score of new products are being, or have been, developed for diseases of the developing world (Table 1), creating new challenges for regulators in Africa and elsewhere. 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. It is 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
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