The Evolving Regulatory Landscape

The panel examines where the regulatory frameworks of ICH M7, the FDA, and EMA currently stand, and where meaningful gaps and divergences remain. The discussion covers the disconnect between scientific consensus and formal regulatory acceptance, the practical implications of inconsistent reviewer responses, and the real-world consequences of divergence between agencies in different markets. The panelists also consider whether there is tolerance for staged or phased compliance approaches, and reflect on what defensible data actually means in the context of a regulatory submission. A sense of cautious optimism emerges around the prospect of greater international convergence, tempered by the recognition that formal guidance and the science underpinning it continue to move at different speeds.

Moderated by Joseph Lackey, Technical Manager at LGC Standards, the discussion brings together Jason Brown, Principal Consultant at Brown Pharma Consulting Ltd, Maria Kristina Parr, a professor in pharmaceutical chemistry from the Freie Universität Berlin, Jörg Schlingemann, Director, Principal Expert Quality Control Systems at Merck Healthcare KGaA, and George Johnson, an associate professor at Swansea University.