A roadmap for supporting the development of advanced therapy medicinal products in a European framework.

Abstract

Advanced therapy medicinal products (ATMPs) represent a paradigm shift in medicine; however, their implementation in European health systems is often hampered by EU regulations. Amidst a rapidly evolving and increasingly competitive global landscape, dominated by the US and China, it becomes imperative that Europe strengthens its position. This requires establishing a dialogue with European authorities to devise new regulatory mechanisms and incentives paving the way for innovation in drug development and implementation. Here, experts from the European University Hospitals Alliance (EUHA) specialising in ATMPs, share their vision on changes needed at the regulatory and organisational level to incentivise the development and clinical use of ATMPs and ensure an equitable and fast access for patients, largely inspired by the problems encountered in an academic environment and in developing ATMPs for rare diseases. To achieve real-world impact, these solutions should be supported by competent authorities at regional, national, and EU levels.