Fajar Dumadi, BSc
International Society for Cell & Gene Therapy (ISCT)
Canada
Following the release of the latest edition of the ISCT CGT Global Regulatory Report—presenting a comprehensive year-end review of 2025—we are proud to share a significant milestone for the Society and its community. ISCT and its Global Regulatory Reports have been featured in the Springer Handbook of Medical Biotechnology, within the chapter titled “Regulatory and Health Technology Assessment of ATMPs in the European Union: Towards Patient Access.”
This recognition highlights the growing impact of ISCT’s thought leadership in addressing some of the most pressing challenges in advanced therapy medicinal products (ATMPs). Despite rapid scientific progress, ATMP development and translation remain slow, costly, and uncertain (1). Even after achieving EU marketing authorization, patient access is not guaranteed, with reimbursement barriers and increasing product withdrawals due to commercial non-viability underscoring the complexity of the landscape (1,2).
The featured chapter draws on insights aligned with ISCT’s work, outlining four key challenges (1): fragmented regulatory procedures, a high burden of proof, limited predictability, and significant budget impact. Together, these issues continue to shape access to innovative therapies across Europe.
This milestone reflects the relevance of ISCT’s Global Regulatory Reports in informing global dialogue and advancing solutions. We encourage members to read the chapter and share it within their networks as we continue working toward improving patient access worldwide.
references
- Bloem, L.T., Fabriek, B.O., Schiel, A., ten Ham, R.M.T. 2026. Regulatory and Health Technology Assessment of ATMPs in the European Union: Towards Patient Access. In: Silva, A.C. (eds) Springer Handbook of Medical Biotechnology. Springer Handbooks. Springer, Cham. https://doi.org/10.1007/978-3-032-01636-2_30
- International Society for Cell & Gene Therapy (ISCT). 2026. Global Regulatory Report. [accessed 12.05.26]. Available from: https://www.isctglobal.org/publications/regulatory-quality-initiatives/global-regulatory-report
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