China GBA Reimbursement and Regulatory Updates

China’s Greater Bay Area (GBA) reimbursement frameworks have progressed to support the GBA Connect Scheme, with six mainland cities—Guangzhou, Shenzhen, Zhuhai, Dongguan, Zhongshan, and Jiangmen—each adapting their own policies. Following Guangdong-approved regulations effective December 1, 2024, these developments promote insurance coverage of GBA-approved medical products, thereby improving access to urgently needed treatments, enhancing healthcare affordability, and fostering greater regional integration.

As of July 21, 2025, the Guangdong Medical Products Administration (MPA) had approved 116 medical products (52 drugs and 64 medical devices) under the GBA Connect Scheme. So far, more than 10,000 patients have already benefited. For further details, see the Guandong MPA announcement.

GBA Reimbursement Policies and Multi-Layered Coverage

Core GBA cities have built tiered medical reimbursement and health insurance systems that incorporate GBA-approved products. As a result, these approaches broaden treatment options and cut out-of-pocket expenses.

City highlights:

• Guangzhou – Covers over 100 high-value innovative drugs and devices, including GBA-approved products. It provides up to RMB 4 million in coverage with zero deductible and full reimbursement for innovative therapies, specific diseases, and proton therapy. Furthermore, the scheme enables direct payment for hospital and designated pharmacy claims, including high-cost treatments such as CAR-T therapy.
• Zhuhai – Combines basic medical, critical illness, and supplementary insurance providing up to RMB 2.59 million in coverage. GBA-approved products are reimbursed at 60% for costs between RMB 10,000 and RMB 300,000. Since March 2025, the program includes reimbursement for Alitretinoin Cream, an innovative treatment approved under the GBA connect scheme for non-segmental vitiligo in patients aged 12 and above, available at Zhuhai People’s Hospital.
• Dongguan – Offers multi-tiered reimbursement for basic expenses, non-catalogue self-paid drugs, rare disease treatments, and GBA-approved products. Specifically, the 2025 annual deductible for GBA-approved products is RMB 40,000.
• Zhongshan – Supplementary insurance covers GBA-approved product costs with a deductible of RMB 40,000. Expenses above that are reimbursed at 50%, up to RMB 200,000.
• Shenzhen – Coverage for 15 GBA-approved products (erdafitinib, bevacizumab, lobaplatin, avelumab, azacitidine, asfotase alfa, tremelimumab, alpelisib, baclofen, isatuximab, ramucirumab, tislelizumab, ruxolitinib, romosozumab, imiquimod). Patients pay the first RMB 31,000 annually (RMB 30,000 for long-term insured), after which 50% of eligible costs are reimbursed up to RMB 500,000. In addition, GBA Connect coverage includes 70% reimbursement with no deductible for anti-D immunoglobulin and reimbursement under basic medical insurance rules for magnetically extendable titanium rods.

Moreover, on July 15, 2025, the Guangdong Administration for Market Regulation announced ongoing policy efforts to support the GBA Connect Scheme and insurance coverage for GBA-approved products. As part of this expansion, Jiangmen became the sixth GBA city to offer reimbursement, joining Guangzhou, Shenzhen, Zhuhai, Dongguan, and Zhongshan. For official details, see the Guandong AMR announcement.

From GBA to NMPA: Regulatory Sequencing and Pipeline Trends

The GBA Connect Scheme serves as a bridge for Hong Kong-approved medical products to enter Mainland China:

1. Hong Kong Approval – Initial market entry for innovative drugs and devices.
2. GBA Approval – Expedited access in designated Mainland hospitals, with real-world data (RWD) collection.
3. China NMPA Approval: RWD supports nationwide market authorization.

Notably, recent approvals show strong momentum in oncology, rare diseases, CAR-T therapies, and advanced medical devices—priority areas for Chinese health authorities.

Implications for Industry Stakeholders

• Manufacturers gain early market entry and a platform for RWD generation.
• Hospitals expand clinical offerings to meet unmet needs.
• Patients benefit from more affordable access, particularly in cities like Shenzhen.
• Insurers can expand portfolios and share financial risks by aligning with GBA policies.
• Healthcare providers need to track designated institutions and coverage rules to guide patients effectively.
• Regulators continue to promote cross-border collaboration, safety monitoring, and innovation.

Coordinated Regulatory Sequencing Transforming Market Access

The coordinated pathway is reshaping medical product access in China:

1. Hong Kong approval
2. GBA entry into designated hospitals
3. Real-world data generation
4. NMPA submission for national authorization
5. Reimbursement expansion through municipal and provincial schemes

By narrowing the regulatory gap between Hong Kong and Mainland China, the GBA Connect Scheme offers companies a faster, more strategic route to market. However, direct NMPA registration remains essential for nationwide access.

In Hong Kong, we provide support for NDA applications for pharmaceutical products as well as MDACS listings for medical devices. For further insights on HK–GBA integration or assistance with your China NMPA registration applications, please contact Cisema.

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