WHO Prequalification
Programme in the Eastern
Mediterranean Region – a
programme for medicines
of priority disease
areas
About the
Programme
The
WHO Prequalification
Programme was launched
in 2001, driven by
global public health
needs, to achieve
universal access to
quality priority
medicines, especially to
those in need. The
Programme strives to
achieve its vision
through close
collaboration with
national medicines
regulatory authorities
and partner
organizations.
The Prequalification
Programme is a service
provided by WHO to
facilitate access to
medicines that meet
unified standards of
quality, safety and
efficacy for HIV/AIDS,
malaria, tuberculosis
and reproductive health.
The Programme is
supported by UNAIDS,
UNICEF, the United
Nations Population Fund
(UNFPA) and the World
Bank as a concrete
contribution to the
United Nations (UN)
priority goal of
addressing the problem
of widespread diseases
in countries with
limited access to
quality medicines.
Prequalification was
originally intended to
give UN procurement
agencies, such as
UNICEF, the choice of a
range of quality
medicines. With time,
the growing list of
products
(i.e. medicines) that
have been found to meet
the set requirements has
come to be seen as a
useful tool for anyone
bulk-purchasing
medicines, including
countries themselves and
other organizations. For
instance, the Global
Fund to Fight AIDS,
Tuberculosis and Malaria
disburses money for
medicines that have been
prequalified by the WHO
process.
Prequalification in the
Eastern Mediterranean
Region
The availability of
quality, safety and
efficacy of medicines is
a major concern of WHO.
To ensure that quality
pharmaceuticals are
available, WHO sets
norms and standards,
develops guidelines and
advises Member States on
issues related to
quality assurance of
medicines in national
and international
markets. These
activities have been
endorsed and supported
by Member States through
numerous World Health
Assembly resolutions.
The Prequalification
Programme is part of
these activities and
WHO’s mandate. It does
not intend to replace
national regulatory
authorities or national
authorization systems
for importation of
medicines, however,
prequalification draws
from the expertise of
some of the best
national regulatory
authorities to provide a
list of prequalified
products that comply
with unified
international standards.
With the exemption of
amodiaquine-artesunate
tablets produced in
Morocco and fixed-dose
combination tablets of
ethambutol-isoniazid-pyrazinamide-rifampicin
produced in Pakistan
(currently suspended),
no other priority
medicines produced in
the Eastern
Mediterranean Region are
on the WHO
prequalification list to
date. This is in spite
of the fact that there
are a number of
producers in the Region
who are producing these
priority medicines; many
of whom are also
exporting medicines and
have the potential for
prequalification of
their products.
In this context WHO
Regional Office, in
collaboration with WHO
headquarters, decided to
systematically promote
the Programme in the
Region. Between June
2007 and January 2009
informative meetings and
training workshops were
organized in five
countries with sizeable
pharmaceutical
industries in the Region
(Egypt, Islamic Republic
of Iran, Jordan,
Pakistan and Syrian Arab
Republic) in order to
raise the awareness of
interested manufacturers
and regulators.
Why
participate in the WHO
Prequalification
Programme?
-
Ensure inclusion on
WHO’s prequalified
list of products.
-
Make
use of opportunities
for fast-track
registration in some
countries.
-
Take
part in global
tenders with
international
procurement agencies
and developing
countries.
-
Ensure that the
capacities of both
local manufacturers
and regulators in
the Region are
strengthened with
reference to the
standards and
requirements of the
Prequalification
Programme through
programme-related
events organized by
WHO in the Region.
-
Receive technical
assistance with
reference to WHO
prequalification
Good Manufacturing
Practices and
bioequivalence
standards.
-
Receive assistance
in preparation and
submission of the
dossier requirement
for prequalification
by WHO.
Informative news
service
How to
apply?
Access the following
link
If you need further
information please,
contact
prequal@who.int
