News

Additional bioequivalence information now required in Module 2.7

In order to improve the PQTm’s depth of knowledge regarding products submitted for prequalification and to better understand their performance as it potentially relates to safety and efficacy, PQTm has introduced a new requirement with respect to the information that should be included in a product dossier:

Effective October 1, 2018, product applications should include the following information in Module 2.7 of the dossier:

  1. A list of of all bioequivalence studies, including pilot studies, conducted with the proposed product i.e., same formulation and manufacturing process as that submitted for prequalification, regardless of the comparator (reference) product employed and regardless of the study outcome. Complete study synopses should be provided for all listed studies, in accordance with Annex I of ICH Guideline E3: Structure and Content of Clinical Study Reports.

  2. A list of all bioequivalence or comparative bioavailability studies, including pilot studies, conducted during pharmaceutical development (development of formulation and/or manufacturing processes) of the product, regardless of the comparator (reference) product employed and regardless of the study outcome. Complete study synopses should be provided for all listed studies, in accordance with Annex I of ICH Guideline E3: Structure and Content of Clinical Study Reports.

Full study reports for all listed studies should be available upon request.