Registering new drugs: the African context. New tools for new times.
This report, commissioned from the George Institute for International Health by DNDi, reviews the various mechanisms and strategies available today to support the registration of new drugs for neglected tropical diseases in developing countries and offers recommendations to further address this issue. It describes the background to the issue and the problems with the current approach which depends largely on regulatory agencies in developed countries; these are experienced and well-resourced but unfamiliar with developing countries and the diseases that affect them. It then discusses the pros and cons of various formal and informal alternative approaches, involving developed-country agencies, the WHO, and/or the improvement of regulation in developing countries; most such approaches are in their infancy. Recommendations are made to optimise neglected disease drug registration for Africa by filling the capacity gap in the short term and strengthening African regulatory agencies in the medium to long term so they can conduct their own regulatory reviews.
Published by The George Institute for International Health, Sydney, New South Wales, Australia; 36 pp.