14/15 December 2023
In 2009, the Committee for Advanced Therapies (CAT) and Committee for Medicinal Products for Human Use (CHMP) adopted the first document on " Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".The ongoing developments in sciences and ATMP regulations necessitate an ongoing update of advice documents as well.
In their release text for the updated version, the EMA explained: "The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
It is an important step forward in the support of developers as it addresses their need for more clarity in the evaluation procedures for these innovative medicines"
During the centralised evaluation of an ATMP, a timely and effective interaction between the EMA and the different committees (CAT, CHMP and the Pharmacovigilance Risk Assessment Committee (PRAC)) in conjunction with the applicant is desirable. The aim of the current document is to describe the procedure for the evaluation of marketing authorisation applications for ATMPs and thus to enable an optimised interaction. Therefore the document gives an overview about the legal basis, the composition of the assessment teams, appointment of rapporteurs and the roles and responsibilities of all interested parties involved in the evaluation procedure for ATMPs. Additionally it includes a standard timetable for the evaluation of an ATMP for initial marketing authorisation application under the centralised application.
For more details please read the complete document "Procedural advice on the evaluation of advanced therapy medicinal product in accordance with Article 8 of Regulation (EC) No 1394/2007".