In the EU, advanced therapy medicinal products (ATMPs), as per Regulation EC 1394/2007 are classified into four main groups: gene-therapy medicines (transgene, type of vector, genetically modified cells); somatic-cell therapy medicines; tissue-engineered medicines; combined ATMPs; using either autologous cells or allogeneic cells.
Even though research into ATMPs is growing, until now, only five ATMPs have been granted a marketing authorization in the EU. Last year, the Innovative Medicines Initiative (IMI) hosted a workshop with industrial players and a group of key opinion leaders to discuss how Europe could play a leadership role in this new generation of therapeutics and whether the IMI platform can facilitate the collaboration to put Europe at the forefront of ATMPs development. Discussion and preliminary recommendations are in a report published by IMI.
IMI and EFPIA are looking for input from scientific, regulatory, patient and healthcare systems communities on the key questions mentioned in the draft report. They have thus opened the draft for public consultation. On the basis of input, a second workshop will be organized by IMI in 2016 that will draw conclusions from and conclude the consultation. These conclusions will inform the development of an IMI ATMP portfolio of projects that could be launched from 2017 onward.
Deadline for submitting comments: 25 July 2016