Deficiencies in generic product dossiers as submitted to the WHO Prequalification of Medicines Programme

This study was undertaken to determine the type and extent of deficiencies in generic product dossiers in the therapeutic areas of HIV/AIDS, tuberculosis, malaria and reproductive health, as submitted to the WHO Prequalification of Medicines Programme. There were considerably more quality-related deficiencies in tuberculosis, malaria and reproductive health dossiers compared to HIV dossiers, especially in the category specification of active pharmaceutical ingredients, development pharmaceutics, manufacturing method and finished pharmaceutical product specifications. The deficiencies related to the efficacy/safety portion of the dossiers displayed a trend similar to that observed in the quality portion in that the most critical deficiencies such as an incorrect study design, the use of an unacceptable comparator or the failure to include a study occurred considerably more frequently in the tuberculosis, malaria and reproductive health dossiers than in the HIV dossiers. The frequency of dossier-related def...