Session (CTI)

ISSUE:As China’s biopharmaceutical ecosystem matures, China-generated clinical trial and real-world evidence are increasingly used to inform global development and access strategies. The key debate is no longer whether such evidence is credible, but whether it is sufficiently relevant, transferable, and decision-ready for European HTA and payer contexts. Clinical trial evidence may be more transferable when design, endpoints, comparators, populations, and execution quality align with international expectations. Real-world evidence is more context-dependent, with challenges around data provenance, coding systems, clinical pathways, standards of care, patient representativeness, and local resource use. The central question for Europe is whether China-generated evidence can serve as core evidence in HTA, or should remain supportive unless transferability is explicitly demonstrated.

OVERVIEW:This issue panel will bring together China HTA, European academic HTA, and European industry perspectives. Jing Wu will discuss how China’s HTA, pharmacoeconomic, and RWE landscape is evolving, and what this means for global evidence generation. Huajie Jin will examine transferability, uncertainty, and how China-generated evidence may be incorporated into European reimbursement and economic evaluation. Ross Selby will discuss evidence planning across markets, access strategy, and post-launch evidence generation from an industry perspective. The session will focus on practical methodological and policy principles for integrating China and European evidence streams in ways that are scientifically credible, HTA-relevant, and supportive of timely patient access. The moderator will use short audience polling questions to stimulate debate, including whether China-generated clinical trial evidence can ever serve as core evidence in European HTA, and whether China-generated RWE should be used as core evidence, supportive evidence, or scenario analysis only.