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However, the manufacturer of IV artesunate recently passed the WHO drug prequalification program (31 ).
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We pooled the results separately for drug registration, WHO-prequalification and licensing of drug outlets, given their differing nature.
In the next years, availability of other classes for second-line regimens, decreased prices and development of new drug formulation, following WHO prequalification and FDA approval of atazanavir/ritonavir FDC in late 2011, should facilitate strategic decisions regarding future switch of first-line combination ART to bPI.
While drug registration and WHO-prequalification of drugs appeared to be effective, the findings for drug registration highlighted the need for routine market surveillance and expansion of regulatory functions to cover local manufacturers and importers.
Overall, we found low quality evidence suggesting that regulatory measures, specifically drug registration and WHO-prequalification of drugs, may be effective in reducing the prevalence of counterfeit and substandard drugs.
Improvements have been noted in several countries due to the establishment of mechanisms such as drug facilities and the WHO/UN Prequalification program (57).
Tanzania's technology transfer agreement was undertaken by a partly state owned company without WHO prequalification of its drugs, another disincentive for private investors.
A procurement organisation has two levers to ensure that only quality drugs enter the system: (1) prequalification criteria to filter out unqualified suppliers and (2) external quality testing protocols.
Three cross-sectional studies examined the association between WHO-prequalification of drugs and changes in failure rates.
For WHO-prequalification of drugs, the quality of WHO-prequalified medicines still varied depending on the country of procurement.
Policymakers and stakeholders would benefit from registration and WHO-prequalification of drugs and may also consider multifaceted interventions.
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