The committee's main responsibility is to prepare a draft opinion on each ATMP application submitted to EMA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the marketing authorisation of the medicine concerned.
At the request of EMA's Executive Director or the European Commission, CAT can also draw up an opinion on any scientific matter relating to advanced therapy medicinal products (ATMPs).
CAT also:
CAT was established in accordance with Regulation (EC) No 1394/2007 on ATMPs as a multidisciplinary committee, gathering some of the best available experts in Europe.
Its work plan includes developing guidance documents, contributing to cross-committee projects, work on simplification of procedures and requirements for ATMPs, training for assessors and organising scientific workshops.
For full details, see the CAT rule of procedure and work plan.
EMA's Committee for Advanced Therapies meets once a month. EMA publishes the agendas, minutes and meeting reports of its plenary meetings.
CAT has been producing meeting reports summarising the main outcomes of its meetings since it was established.
Before start of Committee plenary. EMA has been publishing agendas for CAT since its December 2013 meeting.
After Committee plenary where minutes are adopted. EMA has been publishing minutes for CAT since its December 2013 meeting.
After Committee plenary. As of 2022, CAT quarterly highlights and approved ATMPs replaced its monthly reports.
The CAT held four workshops in cooperation with learned societies to strengthen dialogue with stakeholders and provide guidance for ATMP developers:
Further information on interactions with stakeholders in the field of advanced therapies: