Prequalification Update - 27 April 2012

Expert Review Panel

WHO prequalification of medicines for procurement by UN and other agencies has levelled the playing field and created a competitive supply of quality products in response to donor demand. However, not enough finished products — that have either been prequalified by WHO or authorized by stringent regulatory authorities — are  available to ensure a sustainable supply of all essential medicines needed in treatment programmes.

Since 2009 the WHO Quality and Safety of Medicines Team (QSM) has hosted and coordinated a novel quality risk assessment mechanism on behalf of the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (Global Fund): the Expert Review Panel (ERP).  The work of this expert group does not replace WHO prequalification or stringent regulatory assessment. Rather, ERP’s role is to assess the quality risks of pharmaceutical products that do not yet meet  stringent regulatory requirements.

Based on standardized and transparent criteria the ERP advises whether, each product that is has assessed, could, in principle, be acceptable for procurement, for the next 12 months. Further, it categorizes the products in terms of the quality risks involved.

In its first six session the ERP assessed a total of 310 dossiers of antiretrovirals, anti-tuberculosis products and antimalarials; each session was completed within 4−6 weeks. The outcomes of ERP’s reviews have been crucial to securing a sustained supply of needed medicines, especially anti-TB products and some antimalarials. The cost of ERP review is moderate, as it is a one-off and abbreviated assessment.

The process has been well accepted by manufacturers and procurement agencies, and has promoted progression of medicines to prequalification. Of the 115 eligible products assessed by the ERP during 2009 and 2010, 44 were 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.

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.

The paper posted today gives an overview about ERP: what it is; how it functions; the standards upon which it is based; and the experience obtained so far.

Related Link: 

• A rapid quality risk assessment mechanism for assessing needed pharmaceutical products that have not completed a stringent assessment