Session (CTI)

Real-world evidence (RWE) in China is advancing on multiple fronts at once, spanning regulatory and payer policy, new data sources, and AI applications. This progress reflects growing recognition among regulators, payers, and researchers that real-world data (RWD) can play a larger role in demonstrating the value of new therapies and informing a broad range of health care decisions.
New data solutions — including regional data, disease-specific registries, and multimodal data integration — are emerging to capture richer, more consistently curated data. e, Federated solutions that link institutions and data custodians, offer a path to expand analytic reach while respecting data localization requirements. Artificial intelligence adds a further layer by helping improve data quality and dimensionality, model disease trajectories, and accelerate evidence generation at the scale increasingly expected by decision makers.
On the payer side, national authorities have formalized a comprehensive value-evaluation framework built on RWD, recently designating a cohort of hospitals as trusted sites for generating standardized evidence to support National Reimbursement Drug List (NRDL) negotiations. Regulatory use of RWD can supplement clinical trial evidence and strengthen the totality of evidence for regulatory submissions and post-approval commitments, especially in diseases where conventional randomized evidence may be difficult to generate or may not fully reflect Chinese clinical practice. The speakers will also share examples in which RWE was used to support a more complete evidence package following conditional approval by characterizing relevant Chinese patient populations, treatment patterns, clinical outcomes, and the robustness of findings in real-world practice.
This symposium brings together perspectives on China's evolving RWE landscape, - covering data, payer and regulatory policy and innovation, and the growing application of innovation solutions such as AI — to discuss what it will take for China's RWE to meet the growing stakeholder demands.
Sponsored by Corporate Partner, Analysis Group