This note outlines the basic principles applied by PQP for prioritization of product dossier assessments and inspections of related sites within each therapeutic area.
Prioritization becomes essential when resources are limited.
Prioritization occurs at several levels in PQP:
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when determining which products are to be included in the Invitations for Expression of Interest (EOIs). This prioritization is done by experts outside of PQP
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during screening of dossiers
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during assessment of dossiers
Products are included in the EOIs based on their inclusion in the WHO treatment guidelines and/or WHO's Essential Medicines List (EML). The EOIs constitute a selection of priority products recommended by WHO and are "priority lists" in their own right.
Dossiers are screened for completeness as soon as they are received. Screening ensures that assessment resources are directed to dossiers that meet minimum data requirements, as opposed to dossiers that are incomplete and therefore not yet ready for full assessment.
For more information see the complete Note below.