CAT: Overview

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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 European Medicines Agency, 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 EMA Executive Director or of the European Commission, the CAT can also draw up an opinion on any scientific matter relating to ATMPs.

Other responsibilities of the CAT include:

  • participating in Agency procedures for the certification of quality and non-clinical data for small and medium-sized enterprises developing advanced-therapy medicinal products;
  • participating in Agency 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 Agency'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.

The rules of procedure provide full details of the CAT's responsibilities, composition and the roles of its members.

Work plan 2015-2016

In January 2016 CAT adopted its work plan for 2016. The objectives listed in the work plan include the development of guidance documents, contribution to cross-committee projects, work on simplification of procedures and requirements for ATMPs and the organisation of an ATMP assessor training course and a scientific workshop on cell-based cancer immunotherapy products.

In the context of interactions with its stakeholders, the CAT organised four workshops in cooperation with learned societies to strenghten dialouge with stakeholders and provide guidance for ATMP developers:

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