The European Commission (EC), European Medicines Agency (EMA) and the expert group of the competent authorities of the Member States have developed a new draft guideline on good clinical practice (GCP) for advanced therapy medicinal products (ATMPs). A consultation on the draft guideline is open, and stakeholders are invited to comment by 31st October 2018 at the latest.
The new 14-page draft guideline is specific to clinical trials that are conducted with ATMPs. The guideline will focus on ATMP specificities only and will apply in addition to the GCP guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Comments that are received on the guidance will be taken into account by the European Commission in the finalisation of the guidelines on GCP specific to ATMPs.
Clinical trials that are conducted with ATMPs may be complex to design and conduct, for example, the draft guidance states that “manufacturing constraints and the short shelf-life of the product may require the implementation of tight controls on logistical arrangements to administer the product”. Furthermore, “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.”
The draft 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.
To read more about the targeted stakeholder consultation on the draft guidelines on GCP for ATMPs, please click here.