Evidence map›Paper›PMID 42657305›Full record

ArticleFrontiers in medicine2026

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.

Bingxin Peng, Zhenjie Mo, Yan Yuan, Hui Yao, Liangkui Xu

Abstract read
In one paragraph

Article in Frontiers in medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Bingxin PengSchool of Pharmacy, Guangdong Food and Drug Vocational College, Guangzhou, China.
Zhenjie MoSchool of Chinese Materia Medica, Guangdong Pharmaceutical University, Guangzhou, China.
Yan YuanDepartment of Pharmacy, The First People's Hospital of Foshan, Foshan, China.
Hui YaoDepartment of Clinical Pharmacy, The Second People's Hospital of Foshan, Foshan, China.
Liangkui XuSchool of Pharmaceutical Engineering, Guangdong Food and Drug Vocational College, Guangzhou, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

cross-jurisdictional drug accessdelegated regulatory governanceexpedited drug approval pathwayGuangdong-Hong Kong-Macao Greater Bay AreaHong Kong and Macao medicine and equipment connectpharmaceutical regulationreal-world evidence

Identifiers

PMID42657305
PMCPMC13508815

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.