Bioequivalence and Bioavailability Forum

Dear all,

at the BioBridges 2018 Paola Coppola (MHRA, observer at the CHMP’s PKWP) presented a flowchart explaining how a product-specific BE guidance is developed. The devil is in the details. Once the public consultation of the draft is closed, a preliminary version of the final guidance is sent to the originator only (!) to allow for additional comments within ten days.
That’s problematic because these comments are referring to the preliminary version and not the public draft. It also explains some of the published comments which seemingly were out of context.

Attendees of the generic industry were upset and urged to change in this procedure.