A Rapid Quality Risk Assessment Mechanism for Assessing Needed Pharmaceutical Products that Have Not Completed a Stringent Assessment. WHO Prequalification of Medicines Programme - Briefing Paper: 27 April 2012. Expert Review Panel (ERP)
(2012; 13 pages)


WHO prequalification of medicines for procurement by UN and other agencies has leveled the playing field and created 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 all medicines needed by treatment programmes.

Since 2009 the WHO Quality Assurance and Safety of Medicines Team (WHO-QSM) has hosted and coordinated a novel quality risk assessment mechanism on behalf of the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund): the Expert Review Panel (ERP). This expert group assesses the quality risks of pharmaceutical products that do not yet meet stringent quality requirements. Based on standardized and transparent criteria it then advises whether each product would be acceptable for procurement, for the next 12 months.

The ERP assessed a total of 310 dossiers of antiretrovirals, anti-tuberculosis products and antimalarials in its first six sessions; each session was completed within 4-6 weeks. The cost of ERP review is moderate as it is a one-off and abbreviated assessment. The outcomes have been crucial to 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 were subsequently prequalified by WHO or approved by a stringent regulatory authority. 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 the world to strengthen regulatory capacity in line with internationally accepted standards, so that all medicines are safe, effective and of good quality.

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