WHO TRS (Technical Report Series) 961, 2011 Annex 11

Guidelines on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities

The World Health Organization (WHO) recognizes the scientific evaluation of innovator finished pharmaceutical products (FPPs) by regulatory authorities, which apply similarly stringent standards for quality, safety and efficacy to those recommended by WHO. Where an applicant and a stringent regulatory authority (SRA) can agree to share the following information on an innovator FPP with WHO, WHO will consider such an FPP for inclusion in the list of WHO prequalified products, as and when information about such a product becomes available to WHO and when the applicant in question expresses his or her interest in the product being prequalified by WHO.

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WHO TRS (Technical Report Series) 961, 2011 Annex 11: