Hind Al Belushi, PhDISCT Legal and Regulatory Affairs Committee: EuropeRoyal HospitalSultanate of Oman
Committee of Advance Therapy (CAT)
The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.
Minutes of the meetings
Minutes of the meeting on 10-12 August 2022
Minutes of the meeting on 13-15 July 2022
Agenda for the meeting on 5-7 October 2022
Agenda for the meeting on 7-9 September 2022
CAT quarterly highlights and approved ATMPs (July 2022).
CAT quarterly highlights and approved ATMPs (April 2022).
Updates and regulatory news
FDA User Fee Programs Reauthorizedhttps://www.cellandgene.com/doc/fda-user-fee-programs-reauthorized-fda-s-cber-is-a-clear-winner-0001
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President, currently Ursula von der Leyen.
Revision: Manufacture of Sterile Medicinal Product
Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)
The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
EMA is launching a pilot to support academics and non-profit developers of advanced therapy medicinal products (ATMPs) in the European Economic Area (EEA).
Extension of European Commission Decision Reliance Procedure (EC DRP) until 31 December 2023.
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