Committee for Advanced Therapies (CAT)

Overview

Role and responsibilities

The Committee for Advanced Therapies (CAT) was established in accordance with Regulation (EC) No 1394/2007 on advanced-therapy medicinal products (ATMPs). It is a multidisciplinary committee, gathering together some of the best available experts in Europe to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field.

The main responsibility of the CAT is to prepare a draft opinion on each ATMP application submitted to the EMEA, before the Committee for Medicinal Products for Human Use (CHMP) adopts a final opinion on the granting, variation, suspension or revocation of a marketing authorisation for the medicine concerned. At the request of the EMEA Executive Director or of the European Commission, an opinion is also drawn up on any scientific matter relating to ATMPs.

Other responsibilities of the CAT include:

participating in EMEA procedures for the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced-therapy medicinal products;
participating in EMEA procedures for the provision of scientific recommendations on the classification of advanced-therapy medicinal products in accordance with Article 17 of Regulation (EC) No 1394/2007;
contributing to the EMEA's provision of scientific advice, following relevant procedures established between the CAT and the Scientific Advice Working Party (SAWP);
involvement in any procedure regarding the provision of advice for undertakings on the conduct of efficacy follow-up, pharmacovigilance and risk-management systems of ATMPs;
advising, at the request of the CHMP, on any medicinal product which may require, for the evaluation of its quality, safety or efficacy, expertise in ATMPs;
assisting scientifically in the elaboration of any documents related to the fulfilment of the objectives of Regulation (EC) No 1394/2007;
providing, at the request of the European Commission, scientific expertise and advice for any Community initiative related to the development of innovative medicines and therapies that requires expertise on ATMPs;
assisting, at the request of the CHMP, in the tasks identified in the work programmes of the CHMP working parties.

Composition

The Committee for Advanced Therapies is composed of:

five members of the Committee for Medicinal Products for Human Use (CHMP), with their alternates, appointed by the CHMP itself;
one member and one alternate appointed by each EU Member State whose national competent authority is not represented among the members and alternates appointed by the CHMP;
two members and two alternates appointed by the European Commission to represent clinicians;
two members and two alternates appointed by the European Commission to represent patients associations.

Members of the CAT are appointed for a renewable period of three years. The Chair and Vice-chair of the CAT will be elected from its members for a term of three years, which may be renewed once.

Rules of procedure

Rules of procedure