The European Medicines Agency (EMA) has updated procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The objective of the update is to streamline procedural aspects and strengthen collaboration between EMA’s scientific committees. Further aims include addressing the specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines handle the regulatory process in the European Union (EU).
The procedural advice addresses the developer’s need for more clarity in the evaluation procedures for ATMPs and reinforces timely and effective interactions between the applicants, EMA and its committees. ATMPs are currently assessed by at least three of the EMA’s scientific committees, including the Committee for Advanced Therapies (CAT), the Committee for Medicinal Products for Human Use (CHMP) and the Pharmacovigilance Risk Assessment Committee (PRAC).
The update of the procedural advice resulted from a joint effort between the CAT, CHMP and PRAC, in collaboration with the European Commission (EC), and was adopted by all three committees at their respective December 2017 meetings. A joint action plan was previously published by the EC and EMA in October 2017 to streamline procedures and help address the specific requirements of ATMP developers.
Improvements in the advice include clarity in which situations oral explanations might be needed and while the guidance concentrates on the initial evaluation of new ATMPs, its principles also apply to post-authorisation procedures. Furthermore, the updated advice give developers a greater time to respond to questions raised by the committees by allowing longer clock-stops to prepare answers to questions from EMA’s three committees.
To read the procedural advice on the evaluation of ATMPs, please click here.