New EC Guidelines Address GCPs for Advanced Therapy Products
The European Commission released new guidelines on trials for advanced therapy medical products (ATMPs) in the European Union.
For ATMPs — complex and innovative products that may pose specific challenges to the design and conduct of clinical trials — the agency stresses that sponsors need to carefully track ATMPs containing human cells or tissue, follow up with patients after the end of a trial and train staff on the process of taking biopsies/extracting cells before manufacturing or administering the investigational product.
Control groups receiving the placebo only should not be subjected to a procedure if it presents more than minimal risk and minimal burden, the commission says.
The guidelines are meant to be used in conjunction with the ICH E6 GCP guidelines, but where the two documents diverge, the ATMP guidelines take precedence.