Registering New Drugs: The African Context. New Tools for New Times
(2010; 38 pages)


For many years, African medicines regulatory authorities (MRAs) have managed a broad range of responsibilities, often with limited resources. Their focus has generally been on providing their population with access to a wide range of affordable essential medicines, usually multi-source generics, with less emphasis on rapid access to the latest products. As a result, African national MRAs may have experience in managing generics, but many have only limited experience in assessing, approving and registering innovator products, the vast majority of which are for shared "global" diseases, such as diabetes, hypertension and cancer.

Instead, these innovator products have in virtually all cases been first submitted to Western regulatory authorities - who thus have a great deal of experience in their assessment – and their judgements are, in turn, relied on by many developing country MRAs who may not have the experience or resources to conduct assessments of innovator products themselves.

Recent events have changed this picture, with the result that African MRAs are now being required (sometimes for the first time) to conduct first assessment of novel products that have not previously been reviewed by more experienced regulatory authorities...

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