Un rappel dans le débat: le service de pré-qualification de l'OMS agit pour
améliorer l'assurance qualité des productions de médicaments (ARV,
antipaludiques,...) et à la demande des laboratoires qui leur fournissent un
dossier. L'objectif in fine et de garantir la qualité et de sécurisation des productions ce qui est particulièrement important pour ces médicaments essentiels.
Pour plus d'information : http://apps.who.int/prequal/
Les moderateurs
PREQUALIFICATION PROGRAMME
A United Nations Programme managed by WHO
Vision
Good quality medicines for everyone. Mission
In close cooperation with national regulatory agencies and partner
organizations, the Prequalification Programme aims to make quality priority
medicines available for the benefit of those in need. This is achieved
through its evaluation and inspection activities, and by building national
capacity for sustainable manufacturing and monitoring of quality
medicines.Strategy
Apply unified standards of acceptable quality, safety and efficacy.
Comprehensively evaluate the quality, safety and efficacy of medicinal
products, based on information submitted by the manufacturers, and
inspection of the corresponding manufacturing and clinical sites.
Prequalify quality control laboratories of pharmaceuticals.
Build the capacity of staff from national regulatory authorities, quality
control laboratories, and from manufacturers or other private companies, to
ensure medicines quality.
Key output
The list of prequalified medicinal products used for HIV/AIDS, malaria,
tuberculosis and for reproductive health produced by the Programme is used
principally by United Nations agencies including UNAIDS and UNICEF to guide
their procurement decisions. But, the list has become a vital tool for any
agency or organization involved in bulk purchasing of medicines, be this at
country level, or at international level, as demonstrated by the Global Fund
to Fight AIDS, Tuberculosis and Malaria.