After the launch of such in September 2022, the European Medicines Agency (EMA) initiated a pilot scheme welcoming three academic and non-profit organizations developing advanced therapy medicinal products (ATMPs), providing tailored support to guide them through regulatory processes in the European Union (EU) and aiming to enhance their understanding of requirements to facilitate progress towards marketing authorization. The scheme, intended to assist developers addressing unmet medical needs, plans to include two more participants by the end of 2024.
Among the inaugural participants is the Hospital Clínic de Barcelona, developing ARI-0001, a chimeric antigen receptor (CAR) product targeting relapsed/refractory acute lymphoblastic leukemia. EMA’s commitment to supporting non-commercial developers underscores the significance of their contributions to ATMP development, recognizing the challenges they face in navigating regulatory pathways. While the pilot doesn’t introduce new regulatory tools, participants benefit from fee reductions and waivers, enhancing access to essential support measures. Initial results are slated for release in 2025, with insights from the initiative to be shared in a comprehensive report upon its conclusion. Prospective candidates interested in participating in the pilot can apply through the EMA website or contact the agency directly at atmppilot@ema.europa.eu for further information and to express their interest in participating in the pilot.
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