Circular of Guangzhou Municipal Bureau of Industry and Information Technology on Issuing the Measures to Deepen Institutional & Mechanism Reform, Expand Scenario Application and Support High-Quality Development of the Biomedical Industry

Sui Gongxin Letter〔2026〕No.198

All relevant entities:

The Measures to Deepen Institutional & Mechanism Reform, Expand Scenario Application and Support High-Quality Development of the Biomedical Industry has been approved by the Municipal People’s Government and is hereby issued to you for earnest implementation. Should any problems arise during implementation, please report them to the Municipal Bureau of Industry and Information Technology in a timely manner.

Guangzhou Municipal Bureau of Industry and Information Technology

July 2, 2026

Measures to Deepen Institutional & Mechanism Reform, Expand Scenario Application and Support High-Quality Development of the Biomedical Industry

To resolve prominent bottlenecks restricting the development of the biomedical industry, further advance institutional and mechanism reform as well as the expansion of scenario application in Guangzhou’s biomedical sector, and support Guangzhou’s development into a global hub for biomedical innovation and industrial growth, the following measures are formulated.

I. Strengthen Support for Key Industrial Links

(1) Support Clinical Research

Mutual recognition of medical ethics reviews shall be strengthened. Lead reviewing institutions shall issue review opinions within 15 working days upon acceptance, and participating institutions within 3 working days, targeting a mutual recognition rate of over 90% for multi-center clinical trials. Pilot programs will be launched at high-level provincial and municipal hospitals to promote cross-hospital recognition of ethics review results across Guangdong Province. We will support the establishment of a regional clinical trial consortium in Guangzhou. Relying on a secure electronic medical record sharing system, artificial intelligence will be deployed to streamline subject recruitment, with a goal to cut the overall launch cycle of clinical trial projects to less than 18 weeks.

Responsible entities: Municipal Health Commission, Municipal Administration for Market Regulation (the first listed entity acts as the lead unit unless otherwise specified).

Investigator-initiated clinical trials (IITs) will be supported. After scientific review, ethics review and filing, innovative, safe pharmaceutical and medical device products or technologies may carry out pre-registration clinical verification.

Responsible entity: Municipal Health Commission.

Clinical application research on innovative pharmaceuticals and medical devices will be carried out, led by tertiary hospitals with participation from multiple medical institutions. Research will cover real-world studies, comprehensive clinical value evaluation, and compilation of clinical diagnosis and treatment guidelines and expert consensus. Approved projects will receive policy and data resource support in accordance with laws and regulations. Research outcomes will be leveraged to support applications for inclusion in medical insurance catalogues, renewal negotiations and adjustments to reimbursement scopes.

Responsible entities: Municipal Health Commission, Municipal Medical Insurance Bureau.

(2) Upgrade Guidance and Service Capacity

Pharmaceutical and medical device registration services will be enhanced. A four-level review and approval service mechanism jointly built by central and local authorities will be established. The Guangdong-Hong Kong-Macao Greater Bay Area Branch of the Center for Drug Evaluation and the Center for Medical Device Evaluation under the National Medical Products Administration will be encouraged to provide one-on-one on-site guidance for enterprises. Service capacity will be upgraded at the Huangpu and Nansha service stations of the Review and Certification Center of Guangdong Provincial Drug Administration, as well as the Guangzhou Institute for Drug Control and Guangzhou Medical Device Inspection Center. Efforts will focus on building professional review teams and improving comprehensive services including regulatory consultation, scientific research cooperation, achievement transformation, standard formulation and inspection & testing. Mechanisms such as key project list management will be innovated to accelerate the R&D and launch of innovative pharmaceuticals and medical devices.

Responsible entity: Municipal Administration for Market Regulation; Huangpu District People’s Government, Nansha District People’s Government.

The technical support capacity of the Guangzhou Medical Device Inspection Center will be boosted. Inspection procedures will be optimized to deliver one-stop inspection services, with priority inspection channels set up for key product varieties to shorten testing cycles. Eligible medical device registrants will be exempted from administrative charges for inspection related to product registration as stipulated.

Responsible entity: Municipal Administration for Market Regulation.

Special training and project application counseling will be delivered covering key industrial links including R&D transformation, review and approval, industrialization, medical care and medical insurance.

Responsible entities (separately accountable): Municipal Science and Technology Bureau, Municipal Administration for Market Regulation, Municipal Bureau of Industry and Information Technology, Municipal Health Commission, Municipal Medical Insurance Bureau.

(3) Promote Product Application

Admission of innovative pharmaceuticals and medical devices into medical institutions will be facilitated. Relevant selection policies will be fully implemented. Medical institutions shall hold pharmaceutical affairs committees or medical device committees within one month after the release of innovative products. Such products will be excluded from monitoring indicators including average per-patient medical expense growth and medical service revenue growth.

Responsible entity: Municipal Health Commission.

Marketing and promotion support will be provided for first generic drugs approved by Marketing Authorization Holders, especially those listed in the national Catalogue of Encouraged Generic Drugs.

Responsible entities: Municipal Bureau of Industry and Information Technology, Municipal Health Commission.

Innovative pharmaceuticals and medical devices will be categorized as special items under DIP (Diagnosis Intervention Packet) payment, with enhanced score coefficients and higher DIP reimbursement standards.

Responsible entity: Municipal Medical Insurance Bureau.

A dedicated green channel for innovative pharmaceuticals and medical devices will be launched on the Guangzhou Drug and Medical Consumables Procurement & Trading Platform (GPO Platform). The entire listing process shall take no more than 15 working days after submission and acceptance via the provincial procurement sub-system. Direct settlement between medical insurance authorities and pharmaceutical enterprises will be promoted for innovative drugs and centralized volume-based procurement medicines.

Co-lead entities: Municipal Medical Insurance Bureau, Municipal Health Commission; supporting entity: Municipal Bureau of Government Services and Data Administration.

Promotion and application of the first sets of key technical equipment, first batches of new materials and first editions of new software covering medicine, medical care and medical insurance sectors will be supported.

Responsible entity: Municipal Bureau of Industry and Information Technology.

II. Accelerate Development of Key Industrial Tracks

(4) Drive High-Quality Development of the In Vitro Diagnostics (IVD) Industry

Medical institutions qualified as pilot operators for Laboratory Developed Tests (LDTs) will be supported to take the lead in building joint LDT R&D centers together with third-party medical laboratories, research institutes and manufacturers, alongside the establishment of an LDT project standards committee. Eligible hospitals will be encouraged to cooperate with high-quality IVD enterprises to carry out LDT pilots for IVD products with major clinical demand, mature technologies and controllable risks that have no equivalent domestic products on the market. A regulatory system covering pilot institution administration, product management and exit mechanisms will be explored to form replicable institutional innovation outcomes.

Co-lead entities: Municipal Health Commission, Municipal Administration for Market Regulation.

(5) Boost High-Quality Development of Hospital-prepared Medicines and Traditional Chinese Medicine (TCM) Industry

A Guangdong Provincial Industrial Manufacturing Center for hospital-prepared medicines will be constructed to support high-quality development of hospital pharmaceutical preparations.

Responsible entity: Liwan District People’s Government.

Resource integration and functional upgrading of national and provincial TCM innovation platforms will be supported to strengthen core functions including technical R&D, achievement transformation and talent aggregation, accelerating the translation of innovative outcomes into clinical and industrial applications.

Responsible entities: Municipal Science and Technology Bureau, Huangpu District People’s Government.

Leading TCM enterprises will be supported to collaborate with medicinal herb planting bases and medical institutions to build a full-chain collaborative system covering planting, R&D, clinical practice and industrialization. Distinctive regional TCM brands will be cultivated, well-known national TCM trademarks incubated, and overall brand value of TCM elevated.

Responsible entity: Municipal Bureau of Industry and Information Technology.

Implementation of national demonstration projects for TCM inheritance and innovation will be deepened, with strengthened policy support and whole-process management covering technical inheritance, scientific research innovation, talent development, service upgrading, management systems and cultural branding.

Responsible entity: Municipal Health Commission.

(6) Accelerate Layout of the Nuclear Medicine Industry

Research institutions, enterprises and other entities will be encouraged to conduct cutting-edge technical research on new medical isotope preparation, radiopharmaceutical R&D and high-end diagnostic and therapeutic equipment manufacturing. Domestic substitution of radiopharmaceuticals and high-end nuclear medical equipment already approved and widely used overseas will be accelerated.

Responsible entities: Municipal Science and Technology Bureau, Municipal Development and Reform Commission.

Enterprises will be encouraged to build commercial production projects for medical isotopes via medium and high-energy accelerators. Eligible nuclear medical projects will be included in major project lists to apply for special local government bonds, ultra-long-term special treasury bonds and central special fund support, guiding social capital to invest in the nuclear medical industry.

Responsible entity: Municipal Bureau of Industry and Information Technology.

Nuclear medical industrial parks will be built in Huangpu and Panyu Districts, forming R&D, production, warehousing and logistics bases for radiopharmaceuticals and nuclear medical equipment, with efforts to incorporate them into provincial plans and key provincial projects.

Lead entities (separately): Huangpu District People’s Government, Panyu District People’s Government; supporting entities: Municipal Bureau of Industry and Information Technology, Municipal Development and Reform Commission, Municipal Investment Promotion Committee, Municipal Bureau of Natural Resources and Planning, Municipal Ecology and Environment Bureau, Municipal Science and Technology Bureau, Municipal Health Commission.

Construction of nuclear medicine departments in medical institutions will be promoted. High-level public hospitals will take the lead in upgrading nuclear medicine and radiotherapy departments, aiming for full coverage of nuclear medicine departments in tertiary general hospitals.

Responsible entities: Municipal Health Commission, relevant district people’s governments.

A nuclear medicine industry development alliance led by leading enterprises with participation from universities, research institutes and medical institutions will be established to foster an industrial ecosystem featuring collaborative innovation and full-chain development.

Responsible entities: Municipal Bureau of Industry and Information Technology, Municipal Education Bureau, Municipal Science and Technology Bureau, Municipal Health Commission, Municipal Administration for Market Regulation.

(7) Accelerate Layout of the Cell and Gene Therapy Industry

Implementation paths for aligning Nansha’s relevant pilot policies with national administrative regulations will be explored to sustain the growth of the cell and gene industry. Qualified foreign-invested enterprises will be permitted to engage in R&D and application of human stem cell, gene diagnosis and therapy technologies within the Nansha Free Trade Zone for product registration, launch and production.

Responsible entities: Nansha District People’s Government, Municipal Health Commission, Municipal Administration for Market Regulation, Municipal Science and Technology Bureau.

Expansion of the pilot scope to the Sino-Singapore Guangzhou Knowledge City (Guangzhou Development Zone) will be actively pursued.

Co-lead entities: Municipal Development and Reform Commission, Municipal Bureau of Commerce, Municipal Administration for Market Regulation, Municipal Health Commission; supporting entity: Huangpu District People’s Government.

Local legislation targeting cell and gene therapy in Guangzhou will be advanced.

Responsible entities: Municipal Bureau of Industry and Information Technology, Municipal Bureau of Justice.

Support will be provided for major innovative institutions and national-level platforms in cell and gene therapy, as well as construction of public infrastructure and service platforms including R&D, transformation and evaluation centers for cell technologies and products, medical science and technology innovation transformation platforms, regional cell resource banks and medical research centers.

Responsible entities: relevant district people’s governments, Municipal Science and Technology Bureau.

(8) Accelerate Layout of the Brain-Computer Interface (BCI) Industry

Special supporting policies for BCI technology and industrial development will be formulated and implemented. Cross-industry joint R&D will be promoted between BCI enterprises and players in artificial intelligence, new materials and robotics to build an innovative cross-sector collaboration ecosystem. High-level exhibitions and conferences will be hosted to fully showcase innovative outcomes. Industrial supply-demand matching events will be organized to build an empowerment platform for the sector, break down application barriers and accelerate the commercialization of innovations. The Guangdong-Hong Kong-Macao Greater Bay Area Brain-Computer Interface Industry Alliance will be founded, a Southern BCI Center established, standards formulated, and multi-layer application scenarios expanded covering medical care, consumer electronics and special fields, to build a clustered BCI industrial belt.

Responsible entities: Municipal Science and Technology Bureau, Municipal Bureau of Industry and Information Technology.

Medical device inspection institutions will be guided to benchmark world-class testing bodies and technical standards, continuously upgrading testing and inspection support capacity for the BCI industry. Communication and cooperation with research institutes and leading enterprises will be strengthened to boost mutual advancement of clinical verification and inspection technologies and speed up outcome transformation and application.

Responsible entities: Municipal Administration for Market Regulation, Municipal Science and Technology Bureau, Municipal Bureau of Industry and Information Technology.

III. Deepen Guarantee of Core Production Factors

(9) Drive Innovation of "AI +" Applications

Data aggregation and application in the biomedical sector will be advanced. Coordinated construction will proceed on the Greater Bay Area Biomedical Data Center under Guangzhou Laboratory, the municipal health data middle platform and industry trusted data spaces. Industry databases covering medical and health care, specialized disease treatment, population cohort information and biological samples will be established. Data development and utilization will be carried out in compliance with laws and regulations, alongside cross-border data exchange with Hong Kong and Macao.

Lead entities (separately): Municipal Development and Reform Commission, Municipal Health Commission; supporting entities (per respective duties): Municipal Science and Technology Bureau, Municipal Bureau of Industry and Information Technology, Municipal Bureau of Government Services and Data Administration, Municipal Medical Insurance Bureau.

Development of "AI + pharmaceutical R&D, manufacturing and medical robots" will be supported. Demand collection and "rewarded open bidding" projects for AI-enabled biomedical R&D and manufacturing will be launched to boost collaborative innovation among universities, research institutes, medical institutions and enterprises.

Responsible entities: Municipal Bureau of Industry and Information Technology; People’s Governments of Huangpu, Nansha, Yuexiu, Liwan and Haizhu Districts.

Application of "AI + medical and health care" will be expanded. Key AI applications will be deepened in grassroots medical services, clinical diagnosis and treatment, patient services, TCM, public health, scientific research & education, industry governance and health industries. Application scenarios will be enriched, service capacity elevated, service safety guaranteed, resource allocation optimized, and full-chain intelligent services covering prevention, diagnosis, treatment, rehabilitation and health management innovated.

Responsible entities: Municipal Health Commission, Municipal Development and Reform Commission, Municipal Bureau of Industry and Information Technology.

(10) Optimize Industrial Spatial Layout

A "One Core, Two Poles, Four Nodes" industrial spatial layout will be constructed, with four core industrial parks as key carriers: Huangpu International Biomedical Park, Nansha Life Health Park, Yuexiu Clinical Technology Achievement Transformation Park, and Liwan Modern TCM & High-End Medical Device Park. Projects for reinforcing, supplementing and extending industrial chains will be concentrated within these parks.

Responsible entities: Municipal Bureau of Industry and Information Technology; People’s Governments of Huangpu, Nansha, Yuexiu and Liwan Districts.

A series of characteristic industrial parks will be built, including hospital-prepared medicine parks, IVD industrial parks, nuclear medical industrial parks and organoid medical industrial parks.

Responsible entities: Municipal Bureau of Industry and Information Technology; relevant district people’s governments.

IV. Promote International Development

(11) Advance Industrial Internationalization

A dedicated import and export zone for biomedical products will be built relying on the Guangzhou Knowledge City Comprehensive Bonded Zone, delivering one-stop administrative services, full-chain customs clearance facilitation and diversified logistics support.

Responsible entities: Huangpu District People’s Government, Huangpu Customs, Municipal Bureau of Commerce, Municipal Administration for Market Regulation.

Pilot cross-border commissioned production of Hong Kong and Macao medical devices will be explored. Products entering medical institutions under the "Hong Kong and Macao Medicines and Medical Devices Access Scheme" will be encouraged to complete domestic registration and launch.

Responsible entity: Municipal Administration for Market Regulation.

Training and professional guidance will be provided for biomedical enterprises going global, covering overseas regulatory policy interpretation and product market access.

Responsible entity: Municipal Administration for Market Regulation.

Enterprises and scientists will be encouraged to go global to participate in cooperation and exchanges at top international innovation platforms. Efforts will be intensified to introduce high-quality projects and enterprises led by international award winners.

Responsible entities: Municipal Investment Promotion Committee, Foreign Affairs Office of the Municipal Party Committee, Municipal Bureau of Industry and Information Technology.

(12) Build a World-Class International Medical Service Hub

Medical institutions selected as international medical service pilots will deepen cooperation with overseas medical insurance providers and medical rescue organizations. A streamlined cross-border medical service matching mechanism will be established to expand the scale and influence of international medical services and build a globally competitive international medical hub.

Responsible entities: Municipal Health Commission, Municipal Medical Insurance Bureau.

Yuexiu District will be supported to develop the Guangdong-Hong Kong-Macao Greater Bay Area Life Health Industry Innovation Zone.

Lead entity: Yuexiu District People’s Government; supporting entities: Municipal Development and Reform Commission, Municipal Health Commission.

International medical exchange platforms will be built via medical expos and academic conferences. International medical training programs will be launched to invite medical students and practitioners from Belt and Road Initiative countries and other key regions to receive clinical training in Guangzhou. Focusing on the application of local innovative pharmaceuticals and medical devices, advanced diagnosis and treatment technologies, concepts and models will be promoted to accelerate the global rollout of innovative products.

Responsible entities: Municipal Health Commission, Municipal Bureau of Industry and Information Technology, Foreign Affairs Office of the Municipal Party Committee.

Reminder

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Source: Guangzhou Industry and Information Technology Bureau