The total time to prequalification of a finished pharmaceutical product (FPP) (if full assessment is carried out) depends on the quality of the submitted dossier, and the quality and promptness of the applicant’s subsequent replies to PQTm’s questions during the assessment process, and the results of any inspection carried out. The median WHO time to prequalification has consistently been around 200 days during the past few years. Prequalification of a stringently-approved FPP (i.e. a product already approved by a stringent regulatory authority) does not involve reassessment of the SRA-approved dossier. Instead, PQTm verifies that the product submitted is the same as the one that received SRA approval. The total WHO time to prequalification of an SRA-approved FPP is generally one to two months (median).
The total time to prequalification of an active pharmaceutical ingredient (API) will be reviewed later in 2016 when the benefit of additional resources is expected to become evident.
The total time to prequalification of a medicines quality control laboratory (QCL) is strongly dependent on the outcome of the inspection and, if needed, the speed and efficiency with which the QCL carries out corrective and preventive actions (CAPAs). A QCL may be prequalified immediately after initial inspection (usually conducted within six months of application for prequalification), if no CAPAs or reinspection were required. A shorter timeline of one to two months is possible if a the QCL can provide a report of an inspection or audit performed by a regulatory authority that applies standards that are at least equivalent to WHO-recommended quality standards for QCLs.