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Globally, WHO is striving to provide countries with
adequate support for implementing policies and building capacity to assure
the quality and sustainable supply of all vaccines delivered by national immunization
services.
The WHO policy statement on vaccine quality is that all
vaccines used within national immunization programmes must meet WHO
prequalification requirements for quality and safety. To assure the quality
and safety of vaccines, countries must have in place a system of licensing
the product and product facilities, surveillance for the vaccine performance
in field conditions, lot release, use of laboratory testing when needed,
regular inspection and compliance with good manufacturing practice (GMP) and
evaluation of clinical trial data in licensing decisions. To make sure that
manufacturers comply with these parameters, the country must have a competent
and functioning independent national regulatory authority (NRA).
Prequalification requirements are rigorous and
standardized. A WHO prequalified vaccine has
successfully undergone an evaluation process including review of product
summary files, independent testing of samples, and
site visits to the manufacturer. This procedure ensures that a vaccine is
produced according to methods, specifications, and manufacturing standards
that are internationally acceptable and therefore eligible for purchase by
United Nations agencies. As of October 2003, five manufacturers in the Region
are producing a total of 15 WHO pre-qualified vaccines.
Although almost all of the Region’s vaccines for routine
immunization are now purchased using domestic funds (not donor funds), there
is still substantial procurement from outside the Region and UNICEF is an
important agent in this process.
New technology will play a part in improved vaccine
safety. WHO and UNICEF have committed to supplying all vaccines with vaccine
vial monitors, although there are challenges associated with this new
technology that may hamper its implementation in the Region.
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