WHO recognizes the scientific evaluation of finished pharmaceutical products (FPPs) that has been carried out by stringent regulatory authorities (SRAs), which apply similarly stringent standards for quality, safety and efficacy to those recommended by WHO.
If an applicant is willing to share with WHO information on an FPP that has been approved by an SRA, and that is invited for prequalification, WHO can consider it for inclusion in the WHO List of Prequalified Medicinal Products. In such cases, no assessment of the data underlying the approval by the reference SRA will be undertaken by WHO. However, WHO may request additional data relating to use of the product in populations, settings or regions relevant to the prequalified product. If considered necessary, this additional information will be included in the WHO Public Assessment Report. The SRA-approved product information will not be changed.