{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T15:42:04Z","timestamp":1786549324277,"version":"build-2736575974"},"reference-count":53,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T00:00:00Z","timestamp":1786320000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:p>Launched in 2020, the \u201cHong Kong and Macao Medicine and Equipment Connect\u201d (HKMEC) policy introduced a novel delegated-authority model in China\u2019s 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.<\/jats:p>","DOI":"10.3389\/fmed.2026.1897761","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T11:37:57Z","timestamp":1786361877000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.3389","volume":"13","author":[{"given":"Bingxin","family":"Peng","sequence":"first","affiliation":[{"name":"School of Pharmacy, Guangdong Food and Drug Vocational College","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhenjie","family":"Mo","sequence":"additional","affiliation":[{"name":"School of Chinese Materia Medica, Guangdong Pharmaceutical University","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Yuan","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, The First People's Hospital of Foshan","place":["Foshan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui","family":"Yao","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, The Second People\u2019s Hospital of Foshan","place":["Foshan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liangkui","family":"Xu","sequence":"additional","affiliation":[{"name":"School of Pharmaceutical Engineering, Guangdong Food and Drug Vocational College","place":["Guangzhou, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,10]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"1442328","DOI":"10.3389\/fpubh.2025.1442328","article-title":"China\u2019s health service collaboration in the Guangdong-Hong Kong-Macao Greater Bay Area: barriers and next steps","volume":"13","author":"Wu","year":"2025","journal-title":"Front Public Health"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"118891","DOI":"10.1016\/j.socscimed.2025.118891","article-title":"An infrastructural approach to cross-boundary healthcare access: the case of Hong Kong patients in the Greater Bay Area, China","volume":"390","author":"Yan","year":"2026","journal-title":"Soc Sci Med"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"5","DOI":"10.13407\/j.cnki.jpp.1672-108X.2026.04.002","article-title":"Implementation effectiveness and optimization approach of the \u201cHong Kong and Macao medicine and equipment connect\u201d policy in ensuring drug availability of rare disease","volume":"32","author":"Li","year":"2026","journal-title":"J Pediatr Pharm"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"1025","DOI":"10.1002\/cpt.70198","article-title":"Assessing the \u201cdrug loss\u201d and \u201cdrug lag\u201d for rare diseases in China: a comparative analysis with the United States (2001-2024)","volume":"119","author":"Wang","year":"2026","journal-title":"Clin Pharmacol Ther"},{"key":"ref5","doi-asserted-by":"publisher","first-page":"1400","DOI":"10.1002\/cpt.3227","article-title":"The impact of regulatory reforms in China on drug lag: the role of clinical development strategies","volume":"115","author":"Han","year":"2024","journal-title":"Clin Pharmacol Ther"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"4365","DOI":"10.1016\/j.apsb.2022.08.004","article-title":"Evolution of drug regulations and regulatory innovation for anticancer drugs in China","volume":"12","author":"Liu","year":"2022","journal-title":"Acta Pharm Sin B"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1038\/s41392-025-02267-y","article-title":"Current landscape of innovative drug development and regulatory support in China","volume":"10","author":"Tan","year":"2025","journal-title":"Signal Transduct Target Ther"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"470","DOI":"10.1002\/cpt.70084","article-title":"Innovative drugs approved in China after registration classification reform: current status, disparities, and challenges","volume":"119","author":"Zhu","year":"2026","journal-title":"Clin Pharmacol Ther"},{"key":"ref9","year":"2020"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1007\/s44216-025-00060-w","article-title":"Toward more effective coordination of drug clinical trials in the Greater Bay Area","volume":"4","author":"Lin","year":"2025","journal-title":"Asian Rev Polit Econ"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"83","DOI":"10.15973\/j.cnki.cn11-3708\/d.2022.09.009","article-title":"The \u201cHong Kong and Macao medicine and equipment connect\u201d (HKMEC): a vivid embodiment of Guangdong\u2019s pioneering spirit","volume":"9","author":"Lian","year":"2022","journal-title":"China Health"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"45","DOI":"10.16809\/j.cnki.2096-3653.2022101106","article-title":"Analysis of the policy implementation process of \u201cHong Kong and Macao Yao Xie Tong\u201d from the perspective of model of policy implementation system: based on the research of China resources Guangdong pharmaceutical","volume":"38","author":"Huo","year":"2022","journal-title":"J Guangdong Pharm Univ"},{"key":"ref13","volume-title":"The Implementation Dilemma and Optimization Path of Medical Policy in Guangdong-HongKong-Macao Greater Bay Area \u2014\u2014a Case Study of the \u201cHong Kong and Macao Medicine and Equipment Connect\u201d Policy [master\u2019s thesis]","author":"Xian","year":"2025"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"1721","DOI":"10.13286\/j.1001-5213.2023.15.12","article-title":"Exploring and establishing a real-world data quality management system based on Hong Kong-Macao medicines and devices policy","volume":"43","author":"Zhou","year":"2023","journal-title":"Chin J Hosp Pharm"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"6","DOI":"10.3969\/j.issn.1006-4931.2024.05.002","article-title":"Establishment of evaluation dimensions and indicators for the selection of new drugs based on the \u201cHong Kong and Macao medicine and equipment connect\u201d policy","volume":"33","author":"Li","year":"2024","journal-title":"China Pharm"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"141","DOI":"10.12048\/j.issn.1674-229X.2026.02.010","article-title":"Exploring clinical evaluation tools for drugs under the \u201cHong Kong and Macao medicine and equipment connect\u201d policy","volume":"36","author":"Cailin","year":"2026","journal-title":"Pharm Today"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"1642882","DOI":"10.3389\/fmed.2025.1642882","article-title":"Early access disparities in innovative therapies across the US, EU, China, and Japan","volume":"12","author":"Akodad","year":"2025","journal-title":"Front Med"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"484","DOI":"10.1007\/s43441-022-00480-3","article-title":"Regulatory pathways supporting expedited drug development and approval in ICH member countries","volume":"57","author":"Franco","year":"2023","journal-title":"Ther Innov Regul Sci"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"635","DOI":"10.1186\/s13023-025-04175-4","article-title":"Trends, lag and characteristics of rare disease drug approval in the USA and China, 1983-2022","volume":"20","author":"Wang","year":"2025","journal-title":"Orphanet J Rare Dis"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"426","DOI":"10.1038\/clpt.2011.345","article-title":"Adaptive licensing: taking the next step in the evolution of drug approval","volume":"91","author":"Eichler","year":"2012","journal-title":"Clin Pharmacol Ther"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"2293","DOI":"10.1056\/NEJMsb1609216","article-title":"Real-world evidence - what is it and what can it tell us?","volume":"375","author":"Sherman","year":"2016","journal-title":"N Engl J Med"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"118","DOI":"10.18773\/austprescr.2019.044","article-title":"Fast-track pathways for drug approvals: the Australian experience so far","volume":"42","author":"Bootes","year":"2019","journal-title":"Aust Prescr"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"148","DOI":"10.1002\/cpt.2906","article-title":"European conditional marketing authorization in a rapidly evolving treatment landscape: a comprehensive study of anticancer medicinal products in 2006-2020","volume":"114","author":"Bloem","year":"2023","journal-title":"Clin Pharmacol Ther"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"e069132","DOI":"10.1136\/bmjopen-2022-069132","article-title":"Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006-2021: a cross-sectional study","volume":"13","author":"Xie","year":"2023","journal-title":"BMJ Open"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"4027","DOI":"10.1111\/bcp.14807","article-title":"Achievements and challenges of the Sakigake designation system in Japan","volume":"87","author":"Tanaka","year":"2021","journal-title":"Br J Clin Pharmacol"},{"key":"ref26","year":"2021"},{"key":"ref27","year":"2024"},{"key":"ref28","year":"2021"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"1467","DOI":"10.20223\/j.cnki.1000-8535.2025.11.001","article-title":"Consensus on ethical review of Hong Kong and Macao drug and medical device access in Guangzhou","volume":"56","year":"2025","journal-title":"Guangzhou Med J"},{"key":"ref30","year":"2026"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"68","DOI":"10.3969\/j.issn.1673-5390.2025.08.008","article-title":"Reflections and suggestions on the current status and optimization directions of the \u201cHong Kong and Macao medicine and equipment connect\u201d policy","volume":"8","author":"Sun","year":"2025","journal-title":"China Food & Drug Administration Magazine"},{"key":"ref32","year":"2024"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"528","DOI":"10.16153\/j.1002-7777.2024-12-0043","article-title":"Enlightenment of \u201cHong Kong and Macao medicine and equipment connect\u201d and Lecheng pilot zone policy on anti-tumor drug regulation","volume":"39","author":"Chen","year":"2025","journal-title":"Chin Pharm Aff"},{"key":"ref34","first-page":"1218","volume-title":"Proceedings of the 2024 Emerging Economies Forum","author":"Lin","year":"2024"},{"key":"ref35","doi-asserted-by":"publisher","first-page":"1167","DOI":"10.1007\/s43441-023-00555-9","article-title":"Use of real-world evidence for drug regulatory decisions in China: current status and future directions","volume":"57","author":"Li","year":"2023","journal-title":"Ther Innov Regul Sci"},{"key":"ref36","doi-asserted-by":"publisher","first-page":"1059","DOI":"10.1016\/j.clinthera.2024.09.009","article-title":"Drug review and approval policies based on real-world evidence in China and the United States: a comparative study","volume":"46","author":"Mohetaer","year":"2024","journal-title":"Clin Ther"},{"key":"ref37","first-page":"151","article-title":"Research on local administrative pilot legislation of the \u201cHong Kong and Macao medicine and equipment connect\u201d","volume":"2","author":"Liu","year":"2023","journal-title":"Rule Law Forum"},{"key":"ref38","year":"2022"},{"key":"ref39","year":"2024"},{"key":"ref40","doi-asserted-by":"publisher","first-page":"e005519","DOI":"10.1136\/bmjgh-2021-005519","article-title":"Lowering drug prices and enhancing pharmaceutical affordability: an analysis of the national volume-based procurement (NVBP) effect in China","volume":"6","author":"Yuan","year":"2021","journal-title":"BMJ Glob Health"},{"key":"ref41","doi-asserted-by":"publisher","first-page":"686","DOI":"10.3390\/healthcare13060686","article-title":"Intended and unintended impacts of \u20184+7\u2019 volume-based drug procurement on the use of drugs in China: a natural experimental study","volume":"13","author":"Zhao","year":"2025","journal-title":"Healthcare (Basel)"},{"key":"ref42","doi-asserted-by":"publisher","first-page":"771","DOI":"10.1186\/s12913-024-11217-3","article-title":"The vacated space of volume\/price of the drugs centralized procurement with quantity in secondary and above public hospitals of China","volume":"24","author":"Wang","year":"2024","journal-title":"BMC Health Serv Res"},{"key":"ref43","year":"2022"},{"key":"ref44","doi-asserted-by":"publisher","first-page":"397","DOI":"10.1186\/1471-2458-10-397","article-title":"Comparison of primary care experiences among adults in general outpatient clinics and private general practice clinics in Hong Kong","volume":"10","author":"Wong","year":"2010","journal-title":"BMC Public Health"},{"key":"ref45","doi-asserted-by":"publisher","first-page":"e0121269","DOI":"10.1371\/journal.pone.0121269","article-title":"Comparing quality of public primary care between Hong Kong and Shanghai using validated patient assessment tools","volume":"10","author":"Wei","year":"2015","journal-title":"PLoS One"},{"key":"ref46","doi-asserted-by":"publisher","first-page":"112","DOI":"10.4258\/hir.2022.28.2.112","article-title":"Applying the OMOP common data model to facilitate benefit-risk assessments of medicinal products using real-world data from Singapore and South Korea","volume":"28","author":"Tan","year":"2022","journal-title":"Healthc Inform Res"},{"key":"ref47","year":"2025"},{"key":"ref48","doi-asserted-by":"publisher","first-page":"1419","DOI":"10.3969\/j.issn.1671-332X.2024.09.029","article-title":"Practice and thinking of hospital operation under the policy of \u201cHong Kong and Macao medical device and pharmaceutical access\u201d: a case study of Nansha hospital, Guangzhou first people\u2019s hospital","volume":"24","author":"Fang","year":"2024","journal-title":"Mod Hosp"},{"key":"ref49","doi-asserted-by":"publisher","first-page":"83","DOI":"10.3969\/j.issn.1671-7104.2023.01.015","article-title":"Discuss application of real-world data from the Boao Lecheng pilot zone to support premarket clinical evaluation of medical device","volume":"47","author":"Cai","year":"2023","journal-title":"Chinese J Medical Instrumentation"},{"key":"ref50","year":"2024"},{"key":"ref51","volume-title":"Special Column on Regulatory Innovation and Development of Drugs and Medical Devices in the Guangdong\u2013Hong Kong\u2013Macao Greater Bay Area","year":"2026"},{"key":"ref52","year":"2018"},{"key":"ref53","doi-asserted-by":"publisher","first-page":"7","DOI":"10.1186\/s12962-022-00412-w","article-title":"Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in \u201cBoao Lecheng pilot zone\u201d","volume":"21","author":"Li","year":"2023","journal-title":"Cost Eff Resour Alloc"}],"container-title":["Frontiers in Medicine"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1897761\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T14:41:35Z","timestamp":1786545695000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fmed.2026.1897761\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,10]]},"references-count":53,"alternative-id":["10.3389\/fmed.2026.1897761"],"URL":"https:\/\/doi.org\/10.3389\/fmed.2026.1897761","relation":{},"ISSN":["2296-858X"],"issn-type":[{"value":"2296-858X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,10]]},"article-number":"1897761"}}