BBCT-Hip Qualification advice with EMA - Public Domain Documents

BBCT-Hip qualification advice 

The Bologna Biomechanical Computed Tomography at the Hip (BBCT-Hip) is a digital twin technology that can estimate an individual's risk of fracture at the proximal femur. 

On 04/12/2021, the applicant Mimesis S.r.l., on behalf of the In Silico World Consortium, requested advice from EMA on how to qualify BBCT-Hip as a drug development tool. 

On February 10th, 2022, the applicants had a preliminary informal meeting with the appointed Qualification team. 
The Briefing Book was subsequently resubmitted in its modified version, and the procedure started on the 3rd of April 2022. 

On the 13th of May 2022, EMA sent the applicants a list of issues. 

After submitting the response to the issues document, a discussion meeting with the EMA Qualification Team took place on September 1st, 2022, where the issues and the proposed answers were discussed. 

On the 15th of September 2022, the EMA Committee for Medicinal Products for Human Use adopted the advice to be given to the Applicant.