Navigating regulatory divides: Strategic diplomacy in rare hematology

By Sinan Sarac, M.D., Ph.D., M.Sc. , Senior Vice President, Head of Regulatory Science - Oncology

Mingping Zhang, Vice President, Regulatory Consulting

Published on: May 29, 2026

This article is part of Parexel's Hematology playbook series that is comprised of five chapters on the strategic decisions that separate hematology programs that launch from those that stall — from first-in-human design to post-approval evidence.

Intro Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5

Rare hematological cancers are increasingly defined by specific genetic alterations, which make these patient populations smaller and drug development significantly more complex. The regulatory pathways of the FDA and EMA are diverging in some settings, creating significant strategic challenges for sponsors. In China, years of regulatory reform and vast unmet needs have spurred innovation, especially in hematology. However, policies across these regions, the three largest pharmaceutical markets in the world, are not yet harmonized. 

For sponsors, a viable global regulatory strategy requires early, proactive, and iterative engagement with agencies to reconcile divergent expectations and standards of care (SOC) through meticulous planning and high-quality evidence. 

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