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
医药医疗 / Healthcare & Pharma
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
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
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
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
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