There is increasing demand for real-world evidence (RWE) in healthcare decision making around the global, same as in China. Being the world’s second-largest market (after the US) and the only major market growing in the high single-digits annually, the regulatory and market access environment is evolving rapidly amid the fast development of healthcare sector in China.
The Center for Drug Evaluation (CDE) had published several guidelines on RWE/RWD application in 2020/2021 to provide guidance on how RWE can be used to demonstrate unmet needs, support clinical development, evaluate effectiveness and safety post launch, and help with life cycle management. RWE is also important reference considered in National Reimbursement Drug List (NRDL) negotiation. Different types of RWD with different elements have been used to generate RWE to support regulatory and reimbursement decision making. But there are key challenges and need future development.
Understand the new guidelines on RWE/RWD and their implication on drug development and medical research.
Assess the RWD landscape in China.
Show studies using RWD to facilitate decision making from both regulatory and payer perspectives