Cross-jurisdictional access to innovative drugs and devices: a five-year policy and practice review of the Hong Kong and Macao medicine and equipment connect in the Greater Bay Area of China.

Launched in 2020, the "Hong Kong and Macao Medicine and Equipment Connect" (HKMEC) policy introduced a novel delegated-authority model in China's Greater Bay Area (GBA), enabling designated hospitals to use Hong Kong- or Macao-approved drugs and devices through Guangdong provincial approval, thereby bypassing standard National Medical Products Administration (NMPA) registration. To synthesize five-year implementation evidence, this review followed PRISMA-ScR guidelines and systematically searched Chinese (CNKI, Wanfang, VIP) and English (PubMed, Embase, ScienceDirect) databases covering 2020 to May 2026, supplemented by official documents. By early 2026, the in-use catalog comprised 115 products (45 drugs and 70 devices), while cumulative approvals reached 140 products across 71 institutions, serving more than 17,000 documented patient encounters (as of December 2025; Guangdong Provincial Health Commission, 8 December 2025), mainly in the fields of oncology, rare diseases, and chronic disease. While reliance on external approvals accelerated access, challenges remain, including fragmented real-world data (RWD) infrastructure, self-pay barriers, institutional disparities, and limited cross-border integration. Overall, HKMEC demonstrates a pragmatic delegated regulatory governance model with implications for subnational and transnational pathways, although three priority tasks remain: establishing a regulation-grade RWD platform, advancing financing reforms beyond self-pay, and pursuing substantive collaboration with Hong Kong and Macao. Sustained evidence-driven iteration will be essential to transform this pilot into a robust, scalable model bridging accelerated access and formal regulatory approval.