Guest Column | April 14, 2025
From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials
By Jessica Cordes, senior consultant, Clinical Excellence GmbH
In the EU, among the most critical challenges are those that emerge at the intersection of donor tissue legislation and GMP. For clinical research professionals developing cell therapies and overseeing apheresis procedures, the European Union’s Directive 2004/23/EC serves as a foundational framework. Understanding how this directive interacts with GMP — and where its jurisdiction begins and ends — is essential for successful planning, compliance, and execution.
Please read the full Clinical Leader Article.