Europe – EC Drafts Guideline on GCP for Advanced Therapies

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.”…