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Greater Bay Area 2026: foreign-investment opportunities in healthcare and cross-border medical services

The “Hong Kong/Macao medicine pass” (港澳药械通) had approved 162 innovative drugs and devices (71 drugs, 91 devices) across 71 designated hospitals in all nine GBA cities by late April 2026, serving over 17,000 patient-visits. 截至 2026 年 4 月底,”港澳药械通”已在九市 71 … Greater Bay Area 2026: foreign-investment opportunities in healthcare and cross-border medical servicesRead more

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Pharma opening measures under the 2026 action plan

The 2026 action plan supports rules for drug segmented manufacturing to facilitate overseas marketing-authorisation holders in cross-border segmented production. 2026年行动方案支持出台药品分段生产细则,便利境外药品上市许可持有人开展跨境分段生产。 Pilot regions for biotechnology and wholly-foreign-owned hospitals will be further expanded. 生物技术、外商独资医院开放试点区域将进一步扩大。 Insurers are encouraged to cover more innovative drugs … Pharma opening measures under the 2026 action planRead more

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Healthcare & pharma market access (NMPA)

Market access hinges on NMPA registration, not foreign approval — an FDA/EMA licence does not register a product in China. 市场准入关键在于NMPA注册而非境外批准——FDA或EMA许可并不等于在中国注册。 Imported drugs and devices need a registered China responsible agent to serve as the domestic Marketing Authorisation Holder stand-in … Healthcare & pharma market access (NMPA)Read more

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Wholly Foreign-Owned Hospital Pilot and Private Healthcare Opening

The “Pilot Work Plan for Expanding Opening in the Wholly Foreign-Owned Hospital Sector” (NHC, MOFCOM et al., Guowei Yizhengfa [2024] No. 36) permits wholly foreign-owned hospitals in nine provincial regions. 国家卫生健康委、商务部等四部门《独资医院领域扩大开放试点工作方案》(国卫医政发〔2024〕36号)允许在9个省市设立外商独资医院。 The pilot covers Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, … Wholly Foreign-Owned Hospital Pilot and Private Healthcare OpeningRead more

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Foreign-invested hospitals: the 2026 liberalisation and where they can land

Wholly-foreign-owned hospitals are piloted in nine regions — Beijing, Tianjin, Shanghai, Nanjing, Suzhou, Fuzhou, Guangzhou, Shenzhen and Hainan island — under the Nov-2024 pilot plan; outside those areas foreign-invested hospitals remain equity or cooperative joint ventures. 外商独资医院在九地试点——北京、天津、上海、南京、苏州、福州、广州、深圳及海南全岛——依 2024 年 11 … Foreign-invested hospitals: the 2026 liberalisation and where they can landRead more

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Medical-device import registration and the foreign-device strategy under domestic substitution (2026)

Imported medical devices still require NMPA registration by risk class (I/II/III), and Class II/III overseas manufacturers must register their production sites with the NMPA before any China market entry. 进口医疗器械仍须按风险分类(一/二/三类)取得国家药监局注册;二类、三类境外生产企业须向 NMPA 登记生产场地后方可进入中国。 Volume-Based Procurement has expanded from high-value implants into … Medical-device import registration and the foreign-device strategy under domestic substitution (2026)Read more

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China’s innovative-drug market and the foreign-pharma China playbook (2026)

China’s innovative-drug market is projected to exceed ¥1.3 trillion in 2026, with 2025 out-licensing deals reaching roughly US$135 billion and the first quarter of 2026 alone surpassing US$60 billion. 2026 年中国创新药市场规模预计突破 1.3 万亿元;2025 年对外授权交易总额约 1357 亿美元,2026 年一季度即突破 600 亿美元。 The … China’s innovative-drug market and the foreign-pharma China playbook (2026)Read more