Europe – EC Publishes New Guidelines on Good Clinical Practices for ATMPs

Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies.

The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and administration procedures, traceability, retention of samples, protection of trial subjects, safety reporting and monitoring.

“While the general principles of GCP set out in ICH Guidelines are applicable to clinical trials with ATMPs, in some cases, it may be necessary to adapt those to the specific characteristics of ATMPs (e.g. regarding retention of samples). The implementation of additional measures may also be necessary (e.g. traceability requirements for ATMPs that contain cells or tissues of human origin, follow-up of patients after end of the clinical trial, training on upstream intervention of subjects and/or administration procedures),” the guidelines explain…