Advanced therapies, including gene therapy medicinal products, offer the potential to transform the treatment of conditions that were previously untreatable. However, the UK’s GMO regulatory frameworks were developed before the emergence of modern advanced therapies and do not reflect current scientific and clinical realities. As a result, they create unnecessary barriers for clinical trials.
This new CERSI-AT white paper examines these outdated frameworks and outlines a more streamlined, risk-proportionate model for GMO requirements. The proposed approach integrates biosafety review directly into the clinical trial application process, thereby reducing duplication and administrative burden, accelerating trial start-up timelines, and supporting earlier patient access to innovative therapies while maintaining robust oversight.
