The journey of Advanced Therapy Medicinal Product (ATMP) studies in the European Union

Sponsors developing combined advanced therapy medicinal products (CATMPs) play an important role in advancing potentially groundbreaking opportunities and addressing unmet healthcare needs. European legislation offers incentives for supporting continued research and development of CATMPs and future generations of therapies. Sponsors can also rely on the expertise of the European Medicines Agency (EMA) to assess their state-of-the-art products.

Understanding the distinct requirements for CATMPs

“The development of CATMPs is associated with additional challenges compared to conventional products because each component is often covered by distinct requirements, regulations and guidelines,” explained Sanjay Jain, PhD, PGMP, Senior Director, Global Regulatory Affairs, Fortrea.

“Typically, numerous national agencies/authorities regulate various aspects of ATMPs, and it is different in every Member State, but some Member States provide a single point of contact to ease the regulatory burden,” he added. “The EMA can address questions about the classification of an ATMP or CATMP and will receive scientific recommendations on ATMP classification after consultation with the EC within 60 days after receipt of the request.”

Providing educational resources for ATMP sponsors

As part of the multi-disciplinary and multimodal ATMP or cell and gene therapy (CGT) experience Fortrea offers to sponsors, we also provide educational materials to highlight relevant CGT topics and support the development of these novel products. We believe these efforts help enable more efficient, cost-effective clinical development and reduce risk across critical milestones.

We invite you to read our white paper, “Combined advanced therapy medicinal products: European regulatory requirements, pathways and processes” to get an in-depth review of CATMPs and understand their regulatory framework.