CAT/EMA Collaboration

Published 13 July 2016

EATRIS participated on Thursday 11th of December at the hearing of the Committee for Advanced Therapies (CAT, EMA HQ, London, UK) as an interested party. The main topics of discussion were:

  • Reflection paper on classification of ATMPs. CAT’s current considerations on the following criteria for classification of ATMPs: ‘substantial manipulation’ and ‘non-homologous use’
  • The application of the concept of Risk-based approach (RBA) during the development and marketing authorisation of ATMPs
  • CAT workplan and CAT interested parties focus groups

For more information visit: EMA/CAT and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group