Q&A For Innovators: Navigating The Complex Regulatory World Of ATMPs/CGTs

By Louis Cicchini, Ph.D., Michael Day, Ph.D., and Joerg Schneider, Ph.D., Cencora

Understanding the divergent regulatory standards between international markets is critical for therapy developers. Recent updates to European pharmaceutical legislation now redefine genome editing techniques, while new supply requirements introduce logistical hurdles for personalized therapies. In the U.S., the FDA maintains a high bar for Chemistry, Manufacturing, and Controls (CMC) consistency, particularly regarding the quality of starting materials in early-phase trials.

This Q&A explores these regulatory nuances, the role of orthogonal testing, and the necessity of early engagement with health authorities to ensure successful market entry across different jurisdictions. Dive into this informative discussion for insights that provide the strategic clarity needed to navigate these global hurdles and align development programs with the latest health authority expectations.