The UK Government has unveiled a major regulatory reform aimed at accelerating patient access to innovative therapies by 3–6 months, positioning the UK as a more attractive environment for life sciences innovation and investment. Under a new joint pathway, the MHRA and NICE will offer parallel regulatory and health technology assessments, replacing the current sequential model. This coordinated approach will reduce duplication, compress timelines, and provide earlier clarity on both licensing and reimbursement decisions for developers. The process, launching with a pilot in April 2026, will cover a broad range of products including medicines, personalised therapies, diagnostics, devices, and digital health technologies. Developers will be able to opt in early and receive streamlined, joined-up guidance from both agencies throughout development. In a significant shift, NICE’s statutory funding mandate—currently applicable only to medicines—will be extended to include diagnostics and digital tools. When deemed clinically and cost-effective, these technologies will be routinely funded by the NHS. To support national adoption, the government will establish a single UK-wide formulary within two years, providing greater consistency and reducing post-approval access delays. For industry, these changes promise faster market access, greater regulatory predictability, and enhanced return on innovation, all while reinforcing the UK’s competitiveness in global drug and health tech development. This initiative signals a more agile, innovation-friendly regulatory environment—aligning with broader efforts to strengthen the UK’s leadership in health and life sciences. #MHRA #NICE #NHS #Pharma #Biopharma #Regulatory