Date Published: February 1, 2011
Publisher: Public Library of Science
Author(s): Mary Moran, Nathalie Strub-Wourgaft, Javier Guzman, Pascale Boulet, Lindsey Wu, Bernard Pecoul
Abstract: Mary Moran and colleagues discuss the best strategies for African regulators to
be supported in their efforts to evaluate and approve drugs for their own
Partial Text: 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. However, a recent shift in the drug product
environment for Africa has put this approach under strain. A score of new products
are now being, or have been, developed specifically for diseases of the developing
world (Table 1), creating new
challenges for regulators in Africa and elsewhere.
Historically, the majority of new ND drugs have been first submitted to
well-established Western regulatory authorities (e.g., United States Food and Drug
Administration [FDA], European Medicines Agency
[EMA], SwissMedic), either for routine regulatory review or under
specific pathways such as Orphan Drug legislation (ODL) or expedited approval
mechanisms. Multinational pharmaceutical companies and some Product Development
Partnerships (PDPs) have typically used this approach because it offers clear
protocols and rules, liability management and, in the case of ODL, tax breaks, free
scientific advice, and market exclusivities. Firms also welcome the access Western
regulatory approval provides to early commercial returns on products with
overlapping rich and poor markets.
Policymakers have responded to these shortcomings by developing regulatory pathways
tailored for ND products, including the EMA’s Article 58, WHO drug
prequalification, and FDA “tentative approval”.
In response to the drawbacks of both standard and ND-specific regulatory review,
product developers have begun exploring alternatives, some of which offer insights
for drug registration in Africa. Parallel approvals have been a common strategy for
many PDPs, with dossiers submitted simultaneously to Western and developing country
MRAs. The aim is to achieve high regulatory standards while expediting African
registration. In practice, however, time gains are often illusory, as most African
MRAs wait on WHO or Western approval before commencing their own process. Parallel
approval also fails to assist or build the regulatory capacity of African MRAs.
An optimal drug registration approach for Africa should reliably evaluate safety,
efficacy, and quality of drugs for African use. It should include
African expertise, contribute to building African regulatory capacity, and,
ultimately, expedite African access by reducing duplicative and sequential reviews
by different regulators. However, as the above overview shows, the current system of
ND drug approval is still far from achieving these goals. It is often inefficient,
uses regulatory resources wastefully, and creates lengthy delays for patient access.
Capacity-building opportunities for African regulators are routinely lost and, in
the worst case, regulatory processes and decisions may not meet Africa’s
needs for the best, safest, and most appropriate drugs.