To help developers navigate the ATMP regulatory process in the EU, EMA has released updated procedural advice on their evaluation, aiming to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees, and address specific needs of ATMP developers in the evaluation of marketing authorization applications. The document explains: ● the composition of the assessment teams ● the roles and responsibilities of all interested parties involved in the evaluation proce- dure for ATMPs ● submission deadlines and timetables of the assessment, and ● other details.
EMA also released a draft revised guideline on the safety and efficacy follow-up and risk management of ATMPs. Stakeholders are invited to send their comments by April 30, 2018. The press releases are part of the joint action plan published by the EC and EMA in October 2017.[/membership]