WHO prequalification aims to ensure that diagnostics, medicines, vaccines and immunization related equipment and devices for high burden diseases meet global standards of quality, safety and efficacy, in order to optimize use of health resources and improve health outcomes. The prequalificatoin of a transparent, scientifically sound assessment, which includes dossier review, consistency testing or performance evaluation and site visits to manufacturers. WHO prequalification has become a trusted and reputed symbol for safety, quality and efficacy across stakeholders.
The programme promotes interaction and close collaboration with and between national drug regulatory agencies, in both developing and wealthy countries. The legitimacy of the WHO PQP’s decisions derives in part from this collaboration, and from its solid and transparent procedures and standards. The standards come out of an international consensus process conducted with Member States. The process concludes with review and adoption by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Transparency builds confidence. The WHO PQP goes beyond the current information-sharing practices of national drug regulators.
The programme promotes interaction and close collaboration with and between national drug regulatory agencies, in both developing and wealthy countries. The legitimacy of the WHO PQP’s decisions derives in part from this collaboration, and from its solid and transparent procedures and standards. The standards come out of an international consensus process conducted with Member States. The process concludes with review and adoption by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. Transparency builds confidence. The WHO PQP goes beyond the current information-sharing practices of national drug regulators.