Regulatory Pathways for Advanced Therapies: Meetings and Designations Overview
Author:
Dr Demi Wiskerke
Associate Consultant
Introduction
The evolution of the regulatory landscape for biopharmaceutical and advanced therapy companies demands a focus on aligning innovative technologies, such as platform methods and advanced manufacturing, with the expectations of regulatory agencies. For companies pursuing innovative therapies or cutting-edge manufacturing approaches, proactive engagement with regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has become essential.
Two meeting frameworks—the FDA’s CATT (Center for Advanced Technology Translational) and EMA’s QIG (Quality Innovation Group)—provide platforms for aligning development strategies with regulatory expectations, optimizing approval pathways, and mitigating risks associated with complex technologies…