Access Generic Medicines work-sharing initiative operational procedures update

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) Operational Procedures.

The GMWSI is a work-sharing submission pathway for the coordinated assessment of generic applications that are filed with multiple Access Consortium agencies.

The updates to the GMWSI Operational Procedures include information on the acceptability of reference/comparator products used in bioequivalence (BE) studies submitted with GMWSI applications. This includes details on which Access countries will accept a previously conducted BE study using a Foreign Comparator Product (FCP), and current regulatory requirements regarding the acceptance of FCPs.

It is hoped this information will help facilitate and streamline generic medicine applications submitted under the Access GMWSI pathway.

Additional information and references are also included in the section Related Links below: