Strengthened guidance on follow-up and risk management for ATMP developers

February 1, 2018 – The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs) for a three-month public consultation. The revision is part of the joint action plan published by the European Commission and EMA in October 2017 to streamline procedures and better address the specific requirements of ATMP developers. Stakeholders are … (leggi tutto)