Advanced therapy medicines: towards increased development and patient access
Follow-up activities addressing stakeholder needs
The European Medicines Agency (EMA) has published today a set of ideas to better support development and expand patients' access to high quality, safe and effective advanced therapy medicinal products (ATMPs).
The existing efforts in the area of ATMPs are enriched by these ideas that were developed following a multi-stakeholder expert meeting on advanced therapy medicines organised in May 2016, at which EMA, the European Commission and representatives from the national competent authorities explored together with stakeholders ways to encourage innovation, research and development.
ATMPs, comprising gene therapies, tissue engineered products and somatic cell therapies, have the potential to reshape the treatment of a wide range of conditions. These therapies are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.