Session (CTI)

PURPOSE: The utilization of real-world evidence (RWE) in China has gained significant momentum, influencing key aspects of the product lifecycle, from regulatory approval to market access and physician adoption. The experts in this session will discuss how RWE is being utilized across the product lifecycle in China, analyzing its impact on regulatory decisions, NRDL evaluations, and clinical adoption. We will also explore the opportunities and challenges associated with applying RWE in China’s evolving healthcare landscape.

DESCRIPTION: The session will begin with an interactive audience poll to capture initial thoughts on RWE in China, with a word cloud summary displayed on screen (3min, Zhang). Next, there is an introduction of policy initiatives, e.g., pilot zones in Hainan Boao and the Greater Bay Area and share examples of innovative products that have integrated RWE data into regulatory submissions for accelerated approval (9min, Zhang). Afterwards, we will explore the impact of RWE on reimbursement evaluations and decisions and potential future trends (20min, Liu). Following that, we will consider how RWE is influencing clinical practice, industry dynamics, and the broader healthcare landscape, highlighting the opportunities and challenges it presents (20min, Wu). The session will be concluded by a discussion between the audience and presenters (8 minutes). This discussion will benefit policymakers, researchers, and industry stakeholders by providing insights into the current state and future trends of RWE in China.