Is China Becoming More Attractive to Manufacturers of Innovative Medicines? Insights From the Boao Medical Pilot Zone

OBJECTIVES: Since 2018, medicines approved by regulators outside of China such as the Food and Drug Administration (FDA) can be used in China’s Boao Lecheng International Medical Pilot Zone, if approved by the Hainan authority. In 2019, the Implementation Plan for the Clinical Real-world Data (RWD) Application Pilot was also introduced to facilitate RWD generation in Boao. This research examines the statuses of Boao-authorized medicines to evaluate how this pathway can support both National Medical Products Administration (NMPA) regulatory approval in China as well as National Reimbursement Drug List (NRDL) listing and public reimbursement.

METHODS: Information of Boao-authorized medicines and insurance coverage was extracted from the Lecheng Administration Bureau’s website and official WeChat account (31-Oct-2023). Regulatory information was extracted from the NMPA website (31-Oct-2023). Information of NRDL inclusion was extracted from the National Healthcare Security Administration (NHSA) website (13-Dec-2023).

RESULTS: 101 medicines have been authorized for use in Boao. 45/101 (45%) have been included in the Lecheng Global Special Drug Insurance scheme, which provides commercial supplementary insurance for Hainan citizens. 28/101 (28%) have later received NMPA approval. 4 NMPA marketing authorizations were supported by RWD generated as part of Boao’s Clinical RWD Application Pilot . 10/101 (10%) have subsequently been NRDL-listed.

CONCLUSIONS: Boao has become a channel providing foreign medicines with early access to the China market, with a considerable proportion covered by commercial supplementary insurance, subsequently obtaining NMPA approval and NRDL inclusion. Although few products have gone through Boao’s RWD pilot to date, early examples show that it offers a route of local RWD collection to support NMPA marketing authorization and subsequent NRDL inclusion.