Evaluating ATMPs
The committee’s most important accountability is to arrange a draft opinion on every ATMP utility submitted to EMA, earlier than the Committee for Medicinal Products for Human Use (CHMP) adopts a last opinion on the advertising and marketing authorisation of the drugs involved.
At the request of EMA’s Executive Director or the European Commission, the CAT also can draw up an opinion on any scientific matter regarding superior remedy medicinal merchandise (ATMPs).
Classification and certification of ATMPs and knowledgeable help
The CAT additionally:
- participates in certifying high quality and non-clinical information for small and medium-sized enterprises creating ATMPs;
- participates in offering scientific suggestions on the classification of ATMPs;
- contributes to scientific recommendation, in cooperation with the Scientific Advice Working Party (SAWP);
- takes half in any process delivering recommendation on the conduct of efficacy follow-up, pharmacovigilance or risk-management programs for ATMPs;
- advises the CHMP on any medicinal product which will require experience in ATMPs for the analysis of its high quality, security or efficacy;
- assists scientifically in creating any paperwork regarding the targets of the Regulation on ATMPs;
- gives scientific experience and recommendation for any Community initiative associated to the event of progressive medicines and therapies that requires experience on ATMPs;
- helps the work programmes of the CHMP working events.
The CAT was established in accordance with Regulation (EC) No 1394/2007 on ATMPs as a multidisciplinary committee, gathering a few of the greatest available consultants in Europe. The CAT’s work plan contains creating steering paperwork, contributing to cross-committee initiatives, work on simplification of procedures and necessities for ATMPs, coaching for assessors and organising scientific workshops. For full particulars, see the Committee for Advanced Therapies rule of process and work plan.
Committee for Advanced Therapies (CAT) guidelines of process
First printed: Last up to date: Reference Number: EMA/CAT/454446/2008 Rev. 5
English (EN)
(535.42 KB – PDF)View
Committee for Advanced Therapies (CAT): work plan 2023
First printed: Reference Number: EMA/CAT/910738/2022
English (EN)
(272.1 KB – PDF)View
Evaluating ATMPs
The committee’s most important accountability is to arrange a draft opinion on every ATMP utility submitted to EMA, earlier than the Committee for Medicinal Products for Human Use (CHMP) adopts a last opinion on the advertising and marketing authorisation of the drugs involved.
At the request of EMA’s Executive Director or the European Commission, the CAT also can draw up an opinion on any scientific matter regarding superior remedy medicinal merchandise (ATMPs).
Classification and certification of ATMPs and knowledgeable help
The CAT additionally:
- participates in certifying high quality and non-clinical information for small and medium-sized enterprises creating ATMPs;
- participates in offering scientific suggestions on the classification of ATMPs;
- contributes to scientific recommendation, in cooperation with the Scientific Advice Working Party (SAWP);
- takes half in any process delivering recommendation on the conduct of efficacy follow-up, pharmacovigilance or risk-management programs for ATMPs;
- advises the CHMP on any medicinal product which will require experience in ATMPs for the analysis of its high quality, security or efficacy;
- assists scientifically in creating any paperwork regarding the targets of the Regulation on ATMPs;
- gives scientific experience and recommendation for any Community initiative associated to the event of progressive medicines and therapies that requires experience on ATMPs;
- helps the work programmes of the CHMP working events.
The CAT was established in accordance with Regulation (EC) No 1394/2007 on ATMPs as a multidisciplinary committee, gathering a few of the greatest available consultants in Europe. The CAT’s work plan contains creating steering paperwork, contributing to cross-committee initiatives, work on simplification of procedures and necessities for ATMPs, coaching for assessors and organising scientific workshops. For full particulars, see the Committee for Advanced Therapies rule of process and work plan.
Committee for Advanced Therapies (CAT) guidelines of process
First printed: Last up to date: Reference Number: EMA/CAT/454446/2008 Rev. 5
English (EN)
(535.42 KB – PDF)View
Committee for Advanced Therapies (CAT): work plan 2023
First printed: Reference Number: EMA/CAT/910738/2022
English (EN)
(272.1 KB – PDF)View
