Mapping the Approval Landscape of Europe’s Cell & Gene Therapies
Europe is leading the charge in defining how advanced therapies are approved, reimbursed, and monitored after they reach patients. But until now, these post-approval rules have been scattered across dozens of national HTA decisions and regulatory annexes. Our new Cell & Gene Therapy Evidence & Access Navigator brings it all into one view - showing how each therapy, across the UK, France, Germany, and Italy, is linked to the evidence that sustains its market access.
Seeing the full picture
The Navigator, shown below, allows users to explore 70 therapies authorised or reimbursed in Europe. Each card links to its underlying regulatory and HTA documentation, tracking how obligations evolve across countries. The goal is simple: to make it easier to see where Europe’s post-approval frameworks are converging and where national variations are emerging.
1. Evidence is now a long-term contract
Almost every authorised CGT in Europe carries a 15-year long-term follow-up requirement. Our heatmap makes this clear: across all four major markets, over 90 % of products are monitored through formal LTFU programmes. For AAV-based therapies like Roctavian and Zolgensma, this means routine immunogenicity tracking and durability assessments. For autologous CAR-T and CRISPR therapies, it extends to comparability data whenever manufacturing changes occur.
2. Registries are becoming Europe’s data backbone
The Navigator’s country lens shows that:
Italy leads with fully operational AIFA registries - Breyanzi, Abecma, Carvykti, Yescarta, and Kymriah all run under registry-linked reimbursement.
Germany embeds evidence collection into AMNOG AbD registries, requiring structured post-market data for therapies like Zolgensma and Roctavian.
The UK uses Managed Access Agreements through NICE - gathering outcomes data within defined cohorts.
France remains the most traditional, granting reimbursement after HAS opinions but increasingly layering real-world data commitments on top.
Together, these systems are transforming registries from administrative tools into evidence currencies - the means by which therapies maintain reimbursement over time.
3. Patterns across modalities
Our Insights Dashboard aggregates the data across all therapies:
21 % of products have mandatory registries today - a figure expected to rise as newer approvals enter AIFA and G-BA systems.
91 % have ≥ 15-year follow-up obligations.
84 % carry explicit comparability data requirements.
Across modalities:
In vivo AAV products dominate immunogenicity monitoring.
Ex vivo autologous therapies (CAR-T, CRISPR, lentiviral) anchor the registry-linked access models.
Allogeneic therapies such as Ebvallo show that even donor-cell platforms now fall under long-term oversight.
4. What this means for enabling-tech providers
For the tools and technology companies Lonrú supports, Europe’s CGT evolution creates new commercial signals:
Evidence readiness is market readiness.
Launch success now depends on how well tools integrate with national registries and data standards.
Comparability analytics are a growth driver.
As regulators demand proof of consistency between manufacturing runs, there’s an expanding market for AI-driven release and process-monitoring platforms.
Data interoperability is the next competitive edge.
Enabling-tech firms that can bridge clinical, manufacturing, and payer data will lead Europe’s next phase of CGT industrialisation.
5. A VantagePoint™ for European alignment
By consolidating data from the EMA, NICE, HAS, G-BA, and AIFA, the Navigator provides a single vantage point to watch Europe’s evidence frameworks evolve in real time. Patterns that once required hours of cross-referencing are now visible in seconds.
Explore the Navigator Below
Visitors can filter by therapy, country, or modality; switch to the Evidence Obligations Heatmap to compare follow-up and registry intensity; or dive into the Insights Dashboard to see how obligations cluster across the continent.
About the Navigator
The CGT Evidence & Access Navigator is powered by Lonrú Consulting’s verified dataset (v12_master), built entirely from public sources:
EMA European Public Assessment Reports
NICE, HAS, G-BA, and AIFA decisions and registries
It’s part of our ongoing work to illuminate how post-approval evidence systems shape the future of advanced therapies in Europe.
