EMA: Regulation of advanced therapy medicines

Report details concrete proposals to encourage development and authorisation of advanced therapy medicinal products (ATMPs) in the EU. The European Medicines Agency (EMA) today published a report from a multi-stakeholder expert meeting held on 27 May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue engineered products and somatic cell therapies. These medicines have the potential to reshape the treatment of a wide range of conditions, particularly in disease areas where conventional approaches are inadequate. However, eight years since EU legislation on ATMPs entered into force in 2008, only five ATMPs are currently authorised. At the same time clinical trials investigating ATMPs appear to represent a fast-growing field of interest, underlining the need to better support innovation through a coherent and appropriate regulatory environment.