ISCT Global Regulators Summit
From Reliance to Resilience: Advancing Collaboration in CGT to Support Global Regulatory Development
Tuesday, May 5, 2026 • Closed, Invitation-Only Event
The 4th ISCT Annual Global Regulators Summit will bring together representatives from international regulatory agencies to collaboratively examine the current landscape of regulatory work-sharing initiatives and models for cell and gene therapy products. The dialogue will center on fostering global regulatory alignment and consensus, while also advancing inclusive collaboration strategies that empower low- and middle-income countries (LMICs) in the development and oversight of cell and gene therapy products.
The summit will address:
- Assess Current Work-Sharing and Collaboration Models: conduct a thorough review of existing work-sharing initiatives and regulatory collaboration frameworks, evaluating their effectiveness, efficiency, and relevance to the Cell and Gene Therapy (CGT) field.
- Explore Implementation Challenges: facilitate stakeholder engagement to identify key challenges and barriers to implementing current collaborative approaches in CGT, particularly within low and middle-income countries (LMICs), where regulatory gaps and resource constraints may limit patient access to CGT products.
- Identify Opportunities for Enhanced Collaboration: pinpoint specific areas for strengthening regulatory collaboration and work-sharing among agencies, with a focus on post-marketing evidence generation, integration of real-world data into regulatory decision-making, and capacity-building efforts to support regulatory development in LMICs.
The unprecedented event in 2025 brought together key regulatory leaders and experts from 13 global regulatory agencies and government organizations to address and enhance understanding of the global regulatory landscape for gaining and maintaining accelerated approval for cell and gene therapy products. Agencies and organizations included ANVISA (Brazil), CAT-EMA (European Union), HSA (Singapore), ICMR (India), ISPCH (Chile), MHLW (Japan), NDA (Uganda), NPRA (Malaysia), PMDA (Japan), SFDA (Saudi Arabia), Swissmedic (Switzerland), TFDA (Taiwan), and TGA (Australia).