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The Expert Review Panel
WHO prequalification of medicines for procurement by United Nations (UN) and other agencies has levelled the playing field by creating a competitive supply of quality products in response to donor demand. However, there are still too few WHO-prequalified or stringently authorized finished products available on the market to ensure a sustainable supply of medicines needed in treatment programmes. Since 2009, the WHO Prequalification of Medicines Programme (PQP) has been hosting and coordinating a novel quality risk assessment mechanism on behalf of the Global Fund to Fight AIDS, Tuberculosis and Malaria. The Expert Review Panel (ERP) assesses quality risks of pharmaceutical products which do not yet meet stringent quality requirements. Based on standardized, transparent criteria, it gives advice on whether each product is acceptable for procurement for the next 12 months.
In six review rounds, the ERP has assessed a total of 310 dossiers of antiretroviral medicines (ARVs), antituberculosis products and antimalarials, with a time frame of 4-6 weeks for completion of each round. The cost of ERP review is moderate as it is a once-off, abbreviated assessment. The outcomes have been crucial in securing a sustained supply of needed medicines, especially anti-TB products and some antimalarials.
The process has been well accepted by manufacturers and procurement agencies and has promoted progression of medicines to prequalification. Of 115 eligible products assessed by the ERP in 2009 and 2010, 44 became prequalified or approved by a stringent regulatory authority thereafter. Agencies have harmonized their quality assurance policies and are using the mechanism jointly with the Global Fund. This has resulted in unified quality standards and efficiency gains for all stakeholders.
The ERP approach could be adapted for assessment of additional product categories such as life-saving antibiotics or zinc for the treatment of diarrhoea in children. But it should be borne in mind that ERP is not intended to replace WHO prequalification or stringent regulatory assessment.
Incentives for manufacturers to submit products to ERP for evaluation may remain limited for medicines that have a market outside donor-funded programmes but this does not signify that such products need not adhere to stringent quality standards or that such standards should apply to donor-funded products only. On the contrary, WHO is working with manufacturers and regulators around...