Invitations for Expressions of Interest (EOIs)
quality control laboratories
To manufacturers of medicinal products
The World Health Organization operates the WHO
Prequalification Programme on behalf of the United Nations.
The vision of the WHO Prequalification
Programme is of a world in which good-quality medicines are
available to all those who need them.
facilitates access to good-quality medicines through
assessment of products and inspection of manufacturing
facilities. Products that meet assessment criteria are added
WHO List of Prequalified Medicinal Products.
UN agencies and
others use the List to guide them in their procurement
decisions. Manufacturers of prequalified products may
therefore be invited by WHO
States or UN agencies, or
nongovernmental organizations, to submit tenders for supply
of their prequalified product (preferably at a preferential
price if supply will be to a developing country).
The first step in the prequalification
process consists in the joint issuing, by the WHO
Prequalification Programme, other UN agencies (UNAIDS
of an Invitation for Expression of Interest (EOI). EOIs
focus on products that have been identified by the
respective WHO disease departments as vital to effective
treatment and to expanding treatment programmes. Currently,
this means products for treating HIV/AIDS, TB and malaria,
and for reproductive health. Every product contained in an
EOI is already included on the WHO Model List of Essential
Medicines and/or in WHO treatment guidelines.
Each EOI invites manufacturers to submit a request for an
evaluation of their product(s).
In applying for
product evaluation, manufacturers are requested to submit a
covering letter, product dossier, product sample and site
master file to the WHO Prequalification Programme.
The Programme undertakes comprehensive evaluation of the
quality, safety and efficacy of medicinal products, based on
information submitted by the manufacturers, and inspection
of the corresponding manufacturing sites.
submitted for prequalification are often multi-source
generics. In such
cases, therapeutic equivalence with an innovator product is
verified by performing a bioequivalence study.
Such studies are
generally carried out by an independent
Clinical Research Organization (CRO), which
must therefore also be inspected and approved.
The results - both positive and negative - of
dossier assessments and inspections are relayed carefully to
manufacturers and CROs.