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.