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 policymakers 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.
article disponible :
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.1000411