EC Drafts Guideline on GCP for Advanced Therapies
Posted 06 August 2018 | By
The European Commission (EC) last week opened for consultation a new draft guideline on good clinical practices (GCPs) for advanced therapy medicinal products (ATMPs).
The new 14-page draft guideline was created in consultation with the European Medicines Agency and is specific to clinical trials that are conducted with ATMPs, which may be complex to design and conduct.
“For example, manufacturing constraints and the short shelf-life of the product may require the implementation of tight controls on logistical arrangements to administer the product,” the draft says. “Likewise, the mode of application may render very difficult the use of placebo controls and/or may require specific training. Additionally, the long-term effects of the product may require specific arrangements for long-term follow up of the subjects. Moreover, it is recognised that it may not always be feasible to generate relevant preclinical data before the product is tested in humans.”
GCPs may therefore need to be adapted to specific characteristics of ATMPs, the guideline says.
The guideline features sections on clinical trial design, application dossier, specific considerations concerning the protocol and Investigator’s Brochure, quality of the investigational ATMP, administration procedures, traceability, retention of samples, protection of clinical trial subjects, safety reporting and monitoring.
Stakeholders are invited to comment on this consultation by 31 October 2018 at the latest. Responses should be sent to sante-pharmaceuticals-B5@ec.europa.eu
Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products