By Jessica Cordes – Clinical Leader –
Advanced therapy medicinal products (ATMPs), including cell and gene therapies, have the potential to transform treatment paradigms across oncology, immunology, and rare diseases and are expanding into new indications. Yet these clinical trials require an intricate coordination of clinical, logistical, and regulatory components that span international borders, specialized vendors, and evolving regulatory frameworks.
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.
