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Effective
medicine regulation and quality
assurance are fundamental to public
health. WHO helps countries to:
improve the effectiveness of their
national medicine regulatory
agencies; develop their quality
assurance capacity; improve their
implementation of good manufacturing
practices and their capacity to
inspect medicine distribution
channels; and combat counterfeit and
substandard medicines. WHO collects
and exchanges a significant amount
of information on medicine safety.
The quality of
medicines varies greatly,
particularly in low- and
middle-income countries. The use of
ineffective, poor quality, harmful
medicines can lead to therapeutic
failure, exacerbation of disease,
resistance to medicines and
sometimes death. It also undermines
confidence in health systems, health
professionals, pharmaceutical
manufacturers and distributors.
Money spent on ineffective, poor
quality medicines is wasted –
whether by consumers or governments.
Governments need to establish strong
national regulatory authorities (NRAs),
to ensure that the manufacture,
trade and use of medicines are
regulated effectively, to protect
and promote public health.
WHO’s work in the
area of quality and safety of
medicines has two main components:
the norms and standard-setting
function and the technical
assistance function. In
collaboration with WHO headquarters,
the Regional Office is working
to promote the prequalification
programme for medicines.
Quality of medicines in the Eastern Mediterranean Region
More on
quality and safety of medicines
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