E-DRUG: TM&H article on international medicine registration programmes
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[Abstract copied as Fair Use - DB]
Registering medicines for low-income countries: how suitable are the
stringent review procedures of the World Health Organisation, the US
Food and Drug Administration and the European Medicines Agency?
Joachim Y. Doua*, Jean-Pierre Van Geertruyden
ABSTRACT
New medicines are registered after a resource-demanding process.
Unfortunately, in low-income countries (LICs), demand outweighs
resources. To facilitate registration in LICs, stringent review
procedures of the European Medicines Agency (EMA Article-58), Food and
Drug Administration (FDA PEPFAR-linked review) and WHO Prequalification
programme have been established. Only the PEPFAR-linked review gives
approval, while the others make recommendations for approval. This study
assessed the performance and discussed the challenges of these three
stringent review procedures. Data from WHO, FDA, EMA, Medline and
Internet were analysed. Over 60% of medicines reviewed by stringent
review procedures are manufactured in India. Until 2012, WHO
prequalified 400 medicines (211 vaccines, 130 antiretrovirals, 29
tuberculostatics, 15 antimalarials and 15 others). PEPFAR-linked review
approved 156 antiretrovirals, while EMA Article 58 recommended approval
of 3 antiretrovirals, 1 vaccine and 1 antimalarial. WHO Prequalification
and PEPFAR-linked review are free of charge and as a result have
accelerated access to antiretrovirals. They both built capacity in
sub-Saharan Africa, although WHO prequalification relies technically on
stringent regulatory authorities and financially on donors. Article-58
offers the largest disease coverage and strongest technical capacities,
is costly and involves fewer LICs. To meet the high demand for quality
medicines in LICs, these stringent review procedures need to enlarge
their disease coverage. To improve registration, EMA Article 58 should
actively involve LICs. Furthermore, LIC regulatory activities must not
be fully resigned to stringent review procedure.
Doua, J. Y. and Geertruyden, J.-P. V. (2013), Registering medicines for
low-income countries: how suitable are the stringent review procedures
of the World Health Organisation, the US Food and Drug Administration
and the European Medicines Agency?. Tropical Medicine & International
Health. doi: 10.1111/tmi.12201