The European Commission is preparing to launch Guidelines on Good Clinical Practice (GCP) for Advanced Therapy Medicinal Products (ATMPs), as required by a 2007 regulation. As part of this process, a consultation has been launched, in order to
“give an opportunity for concerned stakeholders to express their views on the GCP requirements that should apply to ATMPs”
The Commission is especially interested in the views of small and medium sized enterprises (SMEs), academia, hospitals and patient organisations, so that they can factor in advice from all sources. The consultation is open until 31 October 2018.