GBA Connect Scheme: 25 New Designated Hospitals and 7th Batch of Approvals

The GBA Connect Scheme is significantly enhancing healthcare accessibility within the Greater Bay Area (GBA). Recently, the program expanded its network by designating 25 new hospitals, bringing the total to 45 across the nine mainland cities. This initiative not only facilitates access to vital medical services but also streamlines the introduction of innovative pharmaceutical and medical solutions from Hong Kong and Macao. As demand for medical products continues to surge, the GBA Connect Scheme is positioned to address the region's evolving healthcare needs effectively.

25 New GBA Designated Hospitals

Recently announced by the Guangdong Provincial Health Commission and the Guangdong Provincial Medical Products Administration, the following 25 new hospitals have been designated under the GBA Connect Scheme:

1. First Affiliated Hospital of Sun Yat-sen University (Nansha)
2. Third Affiliated Hospital of Sun Yat-sen University
3. Sixth Affiliated Hospital of Sun Yat-sen University
4. Sun Yat-sen University Zhongshan Ophthalmic Center
5. Sun Yat-sen University Cancer Prevention and Treatment Center
6. First Affiliated Hospital of Jinan University
7. Guangdong Maternal and Child Health Hospital
8. Guangdong Provincial Traditional Chinese Medicine Hospital
9. First Affiliated Hospital of Guangzhou Medical University
10. Guangzhou Medical University Women and Children's Medical Center
11. Qianhai Life Guangzhou General Hospital
12. Shenzhen Hospital of Southern Medical University
13. People's Hospital of Luohu District, Shenzhen
14. Maternal and Child Health Hospital of Baoan District, Shenzhen
15. Shenzhen New Frontier Health Hospital
16. Shenzhen Hengsheng Hospital
17. Peking University Shenzhen Hospital
18. Fifth Affiliated Hospital of Sun Yat-sen University
19. Fosan Qiming Lin Shun Chao Eye Hospital
20. Third People's Hospital of Huizhou
21. Huizhou Qiming Lin Shun Chao Eye Hospital
22. Donghua Hospital in Dongguan
23. People's Hospital of Zhongshan City
24. Central Hospital of Jiangmen City
25. Zhaoqing Zhengda Guo Health Rehabilitation Hospital

These hospitals are all at least second-tier facilities, ensuring they meet the necessary qualifications for providing medical services associated with Hong Kong and Macao.

7th Batch of GBA Connect Scheme Approvals

On September 12, 2024, the Guangdong Medical Products Administration (MPA) announced the 7th batch of approvals under the GBA Connect Scheme, which includes 10 new medical devices and 10 pharmaceutical products:

10 GBA approved pharmaceuticals in September 2024:

1. Azacitidine
2. Tremelimumab-actl
3. Lurbinectedin
4. Ropeginterferon alfa-2b
5. Ponatinib
6. Asfotase alfa
7. Anifrolumab
8. Mirvetuximab soravtansine-gynx (MIRV)
9. Ruxolitinib
10. Tezepelumab

10 GBA approved medical devices in September 2024:

1. Cardiac Resynchronization Therapy Defibrillator
2. TriClip G4 Delivery System
3. TriClip Steerable Guide Catheter
4. Aurora EV-ICD MRI SureScan SW041
5. Epsila EV MRI SureScan
6. Epsila EV Sternal Tunneling Tool
7. Epsila EV Transverse Tunneling Tool
8. Aurora EV-ICD MRI SureScan
9. EPack
10. Echopulse

As of October 9, 2024, the GBA Connect Scheme has a total of 79 GBA-approved medical products—comprising 39 pharmaceuticals and 40 medical devices—benefiting nearly 10,000 patients in the GBA. This rapid introduction of critical therapies alleviates wait times and ensures that residents can access treatments not yet available on the mainland, especially those with urgent medical needs.

Ongoing Demand of Medical Products in the GBA

In December 2023, Guangzhou customs authorities reported 155 batches of drugs and medical devices imported from Hong Kong and Macao via the GBA connect scheme, with a total value exceeding 21.6 million RMB. This includes six previously approved batches of medical products, highlighting the region's ongoing efforts to enhance healthcare access. The upward trend underscores the increasing importance of regulatory compliance for overseas manufacturers aiming to meet entry criteria and maintain competitiveness in the GBA market. For details of the six previously approved batches, read our 2023 summary report here.

Regulatory Enhancements for Importing Medical Products

On July 31, 2024, new regulations were approved to better manage the import of drugs and medical devices from Hong Kong and Macao into the nine cities of the GBA. These regulations aim to address critical challenges in managing urgently needed medical supplies through a legal framework, thereby promoting high-quality development of the health sector in the region. Additionally, the scheme implements a catalog management system for urgently needed medical products based on clinical demands, with expedited approval times. The review process for non-listed urgent products has been reduced from 35 working days to 20, while listed products will see their approval times cut from 25 working days to just 10. This efficiency marks a 50% reduction in approval times, effectively shifting the focus from patients waiting for medications to ensuring that medications are readily available for patients. For further details, read our blog post on Updated regulations for importing Hong Kong drugs and medical devices starting December 1, 2024.

Further information

Read the announcement on the list of 25 new GBA designated hospitals.

Read the announcement on the 7th batch of approvals under the GBA Connect Scheme.

As the GBA Connect Scheme continues to evolve, it presents unique opportunities for global biopharmaceutical and medical device companies to engage with the rapidly growing market in the GBA. The integration of cross-border healthcare solutions not only improves patient outcomes but also fosters an environment ripe for innovation and collaboration. For further insight into the application procedure in Hong Kong or the China GBA expedited scheme, please reach out to Cisema.

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