Guidelines for preparation of the product summary file for vaccine prequalification
This procedure is targeted to countries that are sourcing their vaccines either through UN agencies or directly from manufacturers, using the WHO prequalified list of products, and that wish to ensure that these products are under appropriate regulatory oversight, but that may lack the resources to carry out a regulatory approval procedure. Because in executing the prequalification process, WHO assures that the necessary regulatory functions are in place, countries that source their vaccines using the WHO prequalified list could expedite the regulatory process for these products by using an expedited approval (fast-track procedure). Such a procedure would recognize the contribution of the WHO prequalification process, while facilitating development of national regulatory capacity. The aim of the fast-track procedure is two-fold: a) to comply with national regulations and international standards of regulatory approval of products and b) to continue to provide timely access to vaccines used in national immunization programs that meet standards of assured quality.
Size: 922 KB