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
ó that have either been prequalified by WHO or
authorized by stringent regulatory authorities
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,
ERPís 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 ERPís 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
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.