E-DRUG: Registering New Drugs for Low-Income Countries: The African Challenge
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[Apologies for the incomplete message that was circulated yesterday. This PLOS article is an excellent summary of the DNDi report of last year. See http://www.dndi.org/images/stories/advocacy/regulatory-report_george-institute-dndi_jan2010.pdf WB]
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000411
Registering New Drugs for Low-Income Countries: The African Challenge
Mary Moran1*, Nathalie Strub-Wourgaft2, Javier Guzman1, Pascale Boulet2,
Lindsey Wu1, Bernard Pecoul2
1 Policy Cures, Sydney, Australia, 2 Drugs for Neglected Diseases initiative (DNDi), Geneva, Switzerland
Summary Points
A recent shift in the drug product environment for Africa has seen a score of new products being developed specifically for diseases of the developing world, 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.
The growing demand to assess novel neglected disease (ND) products for African use has generated a range of responses from policy makers and product developers, but there is limited guidance for product developers in choosing between approaches, and little or no integration between approval mechanisms.
We discuss the various mechanisms in which novel ND drugs are assessed and approved for developing country use, and put forth six recommendations to create an efficient integrated system of national, regional, and international approvals to achieve an optimal drug registration approach for Africa that can reliably evaluate safety, efficacy, and quality of drugs for African use.