Posted by Michael Wonder on 20 Oct 2017
New action plan to foster development of advanced therapies
20 October 2017 - Actions address specific challenges identified by stakeholders.
The European Commission's Directorate-General for Health and Food SafetyExternal link icon (DG SANTE) and the European Medicines Agency (EMA) have published today a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers.
ATMPs are medicines for human use that are based on genes or cells. These therapies offer ground-breaking new opportunities for the treatment of disease and injury. They are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.
ATMPs can be classified into four main groups: gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered medicinal products and combined ATMPs. EMA has received 18 marketing authorisation applications since the ATMP regulation came into force in 2009. Nine products have been approved.
