Regulatory considerations in the development of gene therapies for neurological disorders in the EU region: an industry perspective

Gene therapy medicinal products (GTMPs) offer hope to patients across a broad range of diseases, including neurological disorders. In the European Union (EU), the development of advanced therapies, including GTMPs, is governed by a comprehensive medicines regulatory framework, which has evolved over the last decade. The complexity of this regulatory framework presents some challenges to GTMP developers irrespective of the disease area, where some of the clinical and manufacturing aspects require careful consideration. As science and technology continues to advance there are opportunities for the EU GTMP regulatory framework to develop further in order to keep pace with innovation. The development potential for GTMPs in neurological disorders is an emerging area that shows promise and reflects advances in scientific understanding. However, there are some specific considerations for the development of GTMPs in neurological diseases that must be addressed in order to successfully deliver these promising treatments to patients.

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