Role of the CAT

Evaluating ATMPs

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, the CAT can also draw up an opinion on any scientific matter relating to advanced therapy medicinal products (ATMPs).

Classification and certification of ATMPs and expert support

The CAT also:

  • participates in certifying quality and non-clinical data for small and medium-sized enterprises developing ATMPs;
  • participates in providing scientific recommendations on the classification of ATMPs;
  • contributes to scientific advice, in cooperation with the Scientific Advice Working Party (SAWP);
  • takes part in any procedure delivering advice on the conduct of efficacy follow-up, pharmacovigilance or risk-management systems for ATMPs;
  • advises the CHMP on any medicinal product that may require expertise in ATMPs for the evaluation of its quality, safety or efficacy;
  • assists scientifically in developing any documents relating to the objectives of the Regulation on ATMPs;
  • provides scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies that requires expertise on ATMPs;
  • supports the work programmes of the CHMP working parties.

The 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. The CAT's 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 Committee for Advanced Therapies rule of procedure and work plan.

Committee for Advanced Therapies (CAT) rules of procedure

Committee for Advanced Therapies (CAT): Work Plan 2024

Publication of CAT agendas, minutes and reports

EMA's Committee for Advanced Therapies meets once a month. EMA publishes the agendas, minutes and meeting reports of its plenary meetings. The Committee has been producing meeting reports summarising the main outcomes of its meetings since it was established. 

CAT publication times

Agendas

Before start of Committee plenary. EMA has been publishing agendas for the CAT since its December 2013 meeting.

Minutes

After Committee plenary where minutes are adopted. EMA has been publishing minutes for the CAT since its December 2013 meeting.

Meeting reports

After Committee plenary. As of 2022, CAT quarterly highlights and approved ATMPs replaced CAT monthly reports.

Useful information

CAT meetings in 2022, 2023 and 2024

Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activities

Upcoming CAT meetings

SEE ALL EVENTS

CAT agendas

Agenda of the CAT meeting 13-15 March 2024

Agenda of the CAT meeting 14-16 February 2024

Agenda of the CAT meeting 17-19 January 2024


CAT minutes

Minutes of the CAT meeting 17-19 January 2024

Minutes of the CAT meeting 6-8 December 2023

Minutes of the CAT meeting 30-31 October 2023


CAT meeting reports

CAT quarterly highlights and approved ATMPs - November 2023 - January 2024

CAT quarterly highlights and approved ATMPs - October 2023

CAT quarterly highlights and approved ATMPs - July 2023


Related documents

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