OBJECTIVE: This study aims to assess Real world evidence (RWE) opportunities in China, in particular for pediatric, critical and rare diseases, as well as medical devices for which randomized controlled trial (RCT) could be challenging.

METHODS: RWE related policies and practices in China were reviewed and assessed, combined with case studies based on Simon-Kucher experiences.

RESULTS: RWE could play an increasingly important role in China, ranging from regulatory approvals to access and reimbursements. For regulatory approvals, CDE issued a number of guidelines on RWE applications for the R&D of innovative therapies across drug and devices, and local governments at Hainan and Greater Bay Area have introduced RWE in parallel to early access for innovative therapies seeking China entry. As a result, innovative therapies like Gavreto, XEN and Catalys have been approved in China partially based on RWE, and there are more in the process seeking NMPA approvals partially and purely based on RWE. In addition, RWE is also taken into account in reimbursement decisions like Commercial Health Insurances and NRDL, which would help improve access and affordability of innovative therapies in China.

CONCLUSION: In conclusion, RWE has enabled fast entry and access due to the “patient-centric” mindset in bridging the gap between launch timeline in China vs countries overseas. Pharma and medical device companies shall fully leverage the opportunities presented by RWE to gain fast approval and access for innovative products and services.