《五年規劃》與《2026年施政報告》香港醫療創科進入政策落地期
已更新：2天前
【從自主審評、創新藥械到手術機械人，一文掌握《五年規劃》與《2026施政報告》五大關鍵訊號】
香港首份《五年規劃》與《2026年施政報告》為醫療創科發展提供了前所未有的政策藍圖。相比以往聚焦個別科研資助或試驗項目，今次政策部署更強調建立完整產業生態圈，涵蓋監管制度、臨床研究、醫療應用、病人可及性，以及大灣區協同發展等關鍵環節。
從公共政策及持份者參與角度觀察，這不僅是醫療政策的調整，更反映香港正嘗試打造連接科研創新、醫療服務及產業發展的長遠策略框架。對藥械企業、醫療機構、投資者及病人組織而言，未來五年將是影響市場布局及政策參與的重要窗口期。
【From Independent Drug Reviews and Innovative Medicines to Surgical Robotics: Five Policy Signals from Hong Kong’s First Five-Year Plan and the 2026 Policy Address】
Hong Kong’s first-ever Five-Year Plan, together with the 2026 Policy Address, provides the clearest indication yet that healthcare innovation has become a strategic pillar of the city’s long-term economic and healthcare development agenda. Rather than focusing solely on research funding or isolated innovation initiatives, the Government is now pursuing a more comprehensive framework encompassing regulatory reform, clinical research, technology adoption, patient access, and Greater Bay Area (GBA) integration. It highlights a significant shift towards building a fully connected ecosystem spanning innovation, regulation, healthcare delivery and industrial development.
From a public affairs and government relations perspective, the policy direction signals more than healthcare reform. It reflects Hong Kong’s ambition to position itself as an international life sciences and healthcare innovation hub, connecting world-class research, regulatory expertise, healthcare infrastructure and regional market opportunities. For pharmaceutical companies, medical device manufacturers, healthcare providers, investors and patient organisations, the coming five years will represent a critical period for stakeholder engagement and strategic positioning.
未來香港的定位不再局限於科研平台，而是朝向亞洲醫療創新樞紐發展，結合國際監管接軌、大灣區市場及資本優勢，打造完整生命健康科技生態圈。
Hong Kong’s future role is evolving beyond that of a traditional research and innovation platform. The city is positioning itself as a leading healthcare innovation hub in Asia, leveraging international regulatory alignment, Greater Bay Area market opportunities, and capital market strengths to build a comprehensive life and health technology ecosystem.
五大關鍵政策訊號
5 Key Policy Signals
政策訊號一
香港正建立自主藥械監管及審評體系
政府將成立藥物及醫療器械監督管理中心，推進新藥「第一層審批」及醫療器械法定規管制度，顯示香港正由過往依賴海外認證機制，逐步發展具國際認受性的自主監管能力。
這將是未來數年最值得關注的政策改革之一。對創新藥物及醫療器械企業而言，監管改革不僅影響產品註冊程序，更將對市場准入策略、臨床證據要求、產品責任及上市後監察安排帶來深遠影響。
Policy Signal 1
Hong Kong Is Building an Independent Regulatory and Review Framework
The Government plans to establish a dedicated Drug and Medical Device Regulatory Centre, while progressively implementing the new "Primary Evaluation" pathway for drug registration and introducing statutory regulation of medical devices. These initiatives demonstrate Hong Kong’s intention to evolve from reliance on overseas approvals towards a more internationally recognised independent regulatory system.
This represents one of the most significant healthcare policy reforms of the next decade. For pharmaceutical and medical technology companies, the implications extend beyond product registration. The reforms are expected to influence market access strategies, evidence requirements, regulatory engagement, post-market surveillance obligations, and long-term commercial planning.
政策訊號二
臨床試驗將成為香港醫療創科核心競爭力
政府正積極推動大灣區臨床試驗協作平台、真實世界數據（RWD）應用及國際臨床試驗學院建設，目標是提升香港承接國際及區域臨床研究項目的能力。
關鍵部署
重點措施 政策戰略意義
大灣區臨床試驗協作平台 提高患者招募及研究效率
真實世界數據（RWD） 支援創新藥械審批及市場准入
國際臨床試驗學院 建立臨床研究人才庫
河套合作平台 強化深港科研與醫療協作
香港未來的定位將不只是研發基地，而是有機會成為連接國際研究、監管體系及大灣區市場的重要臨床試驗樞紐。
Policy Signal 2
Clinical Research Is Emerging as a Core Strategic Asset
Hong Kong is strengthening its clinical research capabilities through the Greater Bay Area Clinical Trial Collaboration Platform, Real-World Data (RWD) initiatives, and the forthcoming International Clinical Trial Institute. Together, these measures aim to enhance Hong Kong’s attractiveness as a regional and international clinical research hub.
Strategic Initiative Policy Objective
GBA Clinical Trial Platform Accelerate multi-centre clinical studies
Real-World Data (RWD) Support regulatory approvals and evidence generation
International Clinical Trial Institute Build local research talent
Hetao Collaboration Platform Enhance cross-border clinical and research cooperation
Hong Kong’s future value proposition is likely to extend well beyond research excellence. The city is positioning itself as a gateway connecting global innovation, regulatory science and GBA market opportunities, creating new pathways for innovative medicines and technologies.
政策訊號三
構建「產學研醫」協同生態圈：手術機械人如何成為香港醫療創新發展的示範案例
在《香港首個五年規劃》及《2026年施政報告》的醫療創科布局中，手術機械人正好為其一例子展示政府如何透過推動產業（產）、學術界（學）、科研機構（研）及醫療體系（醫）之間的協作，建立更完整的創新生態圈。政策重點已不再局限於研發資助，而是進一步打通由科研創新、臨床驗證、監管審批、醫院應用，以至產業化及市場拓展的完整鏈條。
過去醫療科技企業最大的挑戰往往是「有技術、缺場景；有創新、缺採用」。HA-TCH醫創融匯辦公室及公營醫院示範平台的設立，將有機會成為未來創新醫療科技進入醫療體系的重要政策接口。
值得關注
公立醫院手術室未來增加44%
京士柏將設全港首個綜合日間醫院
HA-TCH推動創新技術落地
河套支援跨境臨床試驗
手術機械人法規逐步完善
Policy Signal 3
Surgical Robotics and Advanced Medical Technologies as a Showcase of Hong Kong's Healthcare Innovation Strategy
Among the healthcare innovation initiatives outlined in Hong Kong's First Five-Year Plan and the 2026 Policy Address, surgical robotics stands out as a practical example of how the Government intends to strengthen collaboration across industry, academia, research institutions and healthcare providers. Rather than supporting innovation through funding alone, the policy direction aims to connect research, clinical validation, regulatory pathways, healthcare adoption and commercialisation into a more integrated ecosystem
Key Developments
Public hospital operating theatre capacity is projected to increase by 44%
Hong Kong’s first integrated day hospital will be established at King’s Park
HA-TCH will create new pathways for piloting and evaluating innovation
Cross-border clinical trial collaboration will expand through the Hetao platform
A comprehensive regulatory framework for advanced medical devices is being developed
Historically, one of the biggest barriers facing healthcare innovators has been the gap between innovation and adoption.
The establishment of the HA-TCH Office and designated innovation demonstration platforms within public hospitals could become a pivotal mechanism for accelerating the introduction of new technologies into Hong Kong’s healthcare system.
政策訊號四
病人可及性成為醫療改革的重要衡量標準
除了產業發展，政府亦同步加大對癌症及重症患者的支援力度，包括擴充診斷及治療能力、增加新藥評估及資助，以及利用AI提升醫療服務效率。
重點措施
✅ 增加癌症診斷及化療服務容量
✅ 擴展癌症個案經理計劃
✅ 引入更多創新藥物及醫療器械
✅ 推動AI輔助診斷及風險預測
政策焦點正逐步由「能否引入創新」延伸至「病人能否真正受惠」。未來企業在政策倡議及持份者溝通時，需要更積極展示未被滿足醫療需要（Unmet Medical Needs）、健康經濟效益及病人價值。
Policy Signal 4
Patient Access Is Becoming a Key Measure of Policy Success
Alongside industrial development, the Government is placing greater emphasis on ensuring that innovation translates into meaningful patient benefits. The policy package includes expanded diagnostic and treatment capacity, increased evaluation of innovative medicines, and broader access to cancer and rare disease services.
Key Measures
✅ Increased capacity for cancer diagnosis and treatment
✅ Expansion of the Cancer Case Manager Programme
✅ Additional innovative medicines and technologies under evaluation
✅ Greater adoption of AI-enabled diagnostics and risk prediction tools
Healthcare innovation policy is increasingly being evaluated not by whether innovation is introduced, but by whether patients can access and benefit from it. As a result, future stakeholder engagement and policy advocacy efforts will need to focus on unmet medical needs, health economics, patient outcomes and broader societal value.
政策訊號五
大灣區協同發展進入深化階段
政策文件顯示，大灣區合作不再局限於市場拓展，而是進一步擴展至臨床試驗、監管協作、數據應用及人才交流等範疇。
平台 | 預期角色 |
香港 | 國際接軌與監管中心 |
河套 | 臨床試驗及制度創新 |
新田科技城 | 成果轉化及產業化 |
大灣區 | 市場拓展及應用場景 |
對醫療創科企業而言，大灣區策略不應只停留於市場規模考量，更應從研發、臨床驗證、產品註冊、醫療採用及跨境合作等角度制定整體布局。
Policy Signal 5
Greater Bay Area Integration Is Moving Beyond Market Expansion
Policy documents indicate that GBA cooperation is evolving from a market-focused initiative into a broader framework covering clinical research, regulatory collaboration, real-world data utilisation and healthcare talent mobility.
Platform | Strategic Role |
Hong Kong | International gateway and regulatory centre |
Hetao | Clinical trials and policy innovation |
Northern Metropolis | Research translation and industrialisation |
Greater Bay Area | Commercialisation and healthcare deployment |
For healthcare companies, a GBA strategy should not be viewed solely through a commercial lens. Future success will increasingly depend on integrating regulatory planning, clinical development, evidence generation, stakeholder engagement and cross-border collaboration into a coherent regional strategy.
政策觀察
綜觀《五年規劃》及《2026年施政報告》，香港醫療創科政策已由以往的科研資助模式，逐步發展成為涵蓋監管改革、臨床研究、成果轉化、醫院應用及病人可及性的全方位政策框架。
未來值得持續關注的關鍵議題包括：
藥物及醫療器械監督管理中心成立進度
新藥第一層審批制度發展
醫創融匯辦公室（HA-TCH）運作模式
大灣區臨床試驗及真實世界數據應用
創新藥械進入公營醫療系統的完整路徑
上述政策發展將影響香港未來醫療創新競爭力，以及創新技術轉化為病人效益的實際速度。
Policy Perspective
Taken together, Hong Kong’s First Five-Year Plan and the 2026 Policy Address mark a transition from innovation funding towards ecosystem building. Regulatory reform, clinical research, technology adoption, healthcare system transformation and patient access are increasingly being connected through a coordinated policy framework.
The key developments we will continue to monitor include:
Establishment of the Drug and Medical Device Regulatory Centre
Expansion of the Primary Evaluation pathway
Operational rollout of the HA-TCH Office
Greater Bay Area clinical trials and Real-World Data initiatives
The end-to-end pathway for innovative medicines and medical technologies into Hong Kong’s public healthcare system
The pace and effectiveness of implementation will ultimately determine Hong Kong’s competitiveness as a healthcare innovation hub and how quickly patients can benefit from the next generation of medical advances.
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