Committee for Advanced Therapies (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, 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

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.

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.

The CAT held four workshops in cooperation with learned societies to strengthen dialogue with stakeholders and provide guidance for ATMP developers:

• Committee for Advanced Therapies (CAT) Scientific symposium (10/10/2024)
• Committee for Advanced Therapies (CAT) meeting with interested parties (16/05/2023)
• Committee for Advanced Therapies (CAT) meeting with interested parties (26/10/2021)
• Committee for Advanced Therapies (CAT) expert meeting on scientific and regulatory considerations for adeno-associated viral vector (AVV)-based gene therapy (06/09/2017)
• Committee for Advanced Therapies (CAT) workshop: scientific and regulatory challenges of genetically modified cell-based cancer immunotherapy products (15/11/2016 - 16/11/2016)
• Workshop with the European Society for Gene and Cell Therapy (27/10/2011)
• Workshop with the Translational Centre for Regenerative Medicine Leipzig (23/10/2013)
• Workshop with the German Society for Transfusion Medicine and Immunohematology and the German Stem Cell Network (11/09/14)
• Workshop with the International Society for Cellular Therapy (ISCT) in Seville (25/09/2015).

Further information on interactions with stakeholders in the field of advanced therapies:

• Meetings with stakeholders and other organisations