Hospital-exemption cell therapies at scale, backed by a shared registry

The EU hospital exemption (and analogous national point-of-care manufacturing provisions in the UK, Spain, Japan and elsewhere) permits non-routine manufacture of advanced therapy medicinal products for individual patients under national oversight. It is used unevenly and generates little comparable evidence. The proposal is a harmonised framework: common quality standards, a mandatory prospective registry with standard outcome and toxicity capture, and a defined pathway by which registry evidence supports wider use or a conditional marketing authorisation. This lets academic products reach patients years earlier and creates a real-world evidence base for regulators.