This English translation is for reference only. The Chinese version shall prevail in case of any inconsistencies.
Notice of the Executive Committee of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin on Issuing the Several Measures to Support the High-Quality Development of the Biomedicine and Healthcare-related Industries in the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
All bureaus under the Executive Committee:
The Several Measures to Support the High-Quality Development of the Biomedicine and Healthcare-related Industries in the Guangdong-Macao In-Depth Cooperation Zone in Hengqin have been deliberated and approved by the Executive Committee of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin, which are hereby issued for your conscientious implementation. Should any issues arise during implementation, please promptly report the issues to the Economic Development Bureau of the Cooperation Zone.
Executive Committee of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
October 27, 2022
Several Measures to Support the High-Quality Development of the Biomedicine and Healthcare-related Industries in the Guangdong-Macao In-Depth Cooperation Zone in Hengqin
To implement the Master Plan for the Construction of Guangdong-Macao In-Depth Cooperation Zone in Hengqin, promote the development of Macao branded traditional Chinese medicine (TCM) industry, accelerate the growth of healthcare-related industries with a focus on TCM research and manufacturing, build an internationally leading and distinctive new highland for biomedicine and healthcare-related industries, and promote the moderate diversification of Macao’s economy, these Measures have been formulated according to the actual conditions of the Guangdong-Macao In-Depth Cooperation Zone in Hengqin (hereinafter referred to as the “Cooperation Zone”).
Chapter 1. General Provisions
Article 1. Applicable Entities
These Measures apply to enterprises, institutions, and organizations (hereinafter referred to as “institutions”) that are registered, have tax collection and administration relationships, and statistical relationships in the Cooperation Zone. Eligible institutions must possess independent legal entity status, adhere to standardized financial management systems, maintain corporate deposit accounts in banks within the Cooperation Zone, and engage in substantive operations in the biomedicine and healthcare-related industries.
Article 2. Supported Areas
The areas supported by these Measures in biomedicine and healthcare-related industries mainly include:
1.Innovative TCMs, modified new TCMs, complex-formulated TCM preparations derived from ancient classical formulas, TCMs with identical names and identical formulas, and prepared TCM decoction pieces;
2. Biologics, including gene therapies, cell therapies, and synthetic biology products;
3. Chemical medicine featuring new targets, new mechanisms, and new structures;
4. Medical devices such as imaging equipment, implant interventional devices and consumables, in vitro diagnostic instruments and reagents;
5. Healthcare-related products including health foods, foods for special medical purposes, and special-use cosmetics;
6. Contract pharmaceutical outsourcing services and related platforms.
Article 3. Expert Committee
The Cooperation Zone shall establish an Expert Committee Evaluation Mechanism for the development of the biomedical and healthcare-related industries. The Expert Committee, in accordance with the requirements of the Cooperation Zone, shall be primarily responsible for conducting technical assessments and providing opinions and recommendations on matters related to the development of the biomedical and healthcare-related industries and the implementation of projects within the Cooperation Zone. The opinions and recommendations of the Expert Committee shall serve as an important reference for decision-making in the development of the biomedical and healthcare-related industries.
Chapter 2. Support for Project Implementation
Article 4. Support for the Introduction of High-Quality Macao-Invested Projects
Support shall be provided for the establishment of high-quality Macao-invested projects in the Cooperation Zone. For Macao-invested projects that meet the requirements of Articles 5 and 6, an additional 20% subsidy will be granted on top of the calculated subsidy standards. Moreover, strong support shall be offered in terms of site provision, project facilitation services, and other related areas.
Article 5. Support for the Introduction of Major Projects
Projects that play a leading role in driving the development of biomedicine and healthcare-related industries, and that involve a substantial total fixed asset investment (excluding land costs, as defined below) shall be eligible for subsidies ranging from 10% to 30% of their total fixed asset investment. This generally applies to projects with a minimum investment of 200 million yuan. The maximum subsidy granted to a single project shall not exceed 600 million yuan.
Article 6. Support for the Introduction of Benchmark Projects
Efforts shall be made to attract globally competitive industrial projects characterized by strong research and development and good growth. For qualified enterprises, including those among the Fortune Global 500, the top 50 global pharmaceutical and medical device companies, the top 100 Chinese pharmaceutical companies, specialized and innovative “little giant” enterprises recognized by the Ministry of Industry and Information Technology, industry unicorns, leading companies in niche sectors, as well as domestic and international enterprises that have been listed or secured investments exceeding 10 million yuan from authoritative investment institutions (including the top 30 companies in the healthcare sector from authoritative rankings such asZero2IPO and Chinaventure), a one-time subsidy shall be granted as follows: 1. For actual operating entities and research and development institutions established in the Cooperation Zone with a paid-in registered capital of over 10 million yuan, a one-time subsidy of 10% of the paid-in capital shall be granted, capped at a maximum of 5 million yuan; 2. For entities that purchase property in the Cooperation Zone for research and development, production, and office use, a one-time subsidy of 10% of the purchase amount shall be granted, capped at a maximum of 10 million yuan; 3. For entities that engage in actual research and development activities, a one-time subsidy shall be provided for 50% of the R&D expenses incurred in that year, capped at a maximum of 18 million yuan.
Chapter 3. Promotion of the “Macao Registration+Hengqin Production” Brand
Article 7. Encouraging the Macao Registration of TCM Products Developed in Hengqin
Support shall be provided for innovative TCMs, modified new TCMs, complex-formulated TCM preparations derived from ancient classical formulas, and TCMs with identical names and identical formulas developed in the Cooperation Zone that obtain clinical trial approval or registration certificates from Macao’s Pharmaceutical Administration Bureau through affiliated companies in Macao. Based on research progress and actual R&D expenditures, an additional 20% shall be granted for the rewards calculated according to the standards outlined in Article 10. For independently developed products submitted for approval in both Macao and Chinese Mainland through affiliated companies, the higher reward standard from Macao registration shall be applied, or the difference shall be supplemented.
Article 8. Support for Biomedicine and Healthcare-relate Products Produced in Hengqin
1. For TCM products, food products and health products approved and registered in Macao and produced in the Cooperation Zone, and permitted to use the signs “production supervised by Macao”, “produced by Macao” or “design by Macao”, a subsidy of 20% of actual production costs shall be granted to the marketing authorization holders (including registrants, as defined below) associated with companies in the Cooperation Zone, with a maximum subsidy of 20 million yuan for each product. The annual total subsidy for each institute shall not exceed 40 million yuan.
2. For biomedicine and healthcare products that meet the requirements outlined in Chapter Ⅳ and are approved and registered by the National Medical Products Administration (NMPA), the State Administration for Market Regulation, or the Guangdong Provincial Medical Products Administration, and produced in the Cooperation Zone, a subsidy of 20% of actual production costs shall be awarded to the marketing authorization holders, with a maximum of 18 million yuan for each product. The annual total subsidy for each institute shall not exceed 36 million yuan.
3. Support shall be provided for enterprises in the Cooperation Zone to obtain production licenses for biomedicine and healthcare products. A reward of 1 million yuan shall be given for obtaining a new drug production license (Categories A, C, D); 600,000 yuan for a new drug production license (Category B); 500,000 yuan for a new medical device production license (Categories II and III); 300,000 yuan for a new food production license; and 200,000 yuan for a new license for the production of special-use cosmetics.
4. Coordinated development with Zhuhai shall be supported. For projects developed in the Cooperation Zone but unable to be produced or processed there, support shall be provided for establishing production bases in Zhuhai City, with specific support measures to be negotiated and determined by the Executive Committee of the Cooperation Zone and the Zhuhai Municipal People's Government.
Article9.Promotion of the Internationalization of “Macao Registration+Hengqin Production”
1. International registration shall be encouraged. For biopharmaceutical and healthcare products developed in the Cooperation Zone that have obtained registration through international bodies such as those in the “Belt and Road Initiative” and Portuguese-speaking countries, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union (CE), the Japan Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO), and have achieved exports to those countries, a subsidy of up to 12 million yuan per product shall be provided, based on 30% of the actual R&D and certification costs.
2. The introduction of imported new drugs shall be encouraged. For exclusive imported drugs with significant clinical advantages and good market prospects, whose marketing authorization holder (or an agent designated in the Cooperation Zone) and sales headquarters are registered in the Cooperation Zone, and full-caliber statistics and settlements are conducted within the Cooperation Zone, a subsidy of up to 36 million yuan per product will be provided, based on 30% of the actual investment costs, after obtaining the drug registration certificate issued by the NMPA.
3. Standardization of quality management shall be strengthened. For institutions that pass the Good Manufacturing Practice (GMP) certification by China or international GMP certification (from the U.S., Japan, EU, or WHO), a subsidy of up to 1.2 million yuan will be provided, based on 50% of the actual investment costs.
Chapter 4. Strengthening R&D Support
Institutions within the Cooperation Zone that conduct clinical trials domestically and carry out results transformation within the Cooperation Zone, and subsequently obtain clinical trial approvals (Clinical Trial Notification), registration certificates for drugs, medical devices, or health products from the National Medical Products Administration (NMPA), the State Administration for Market Regulation, or the Guangdong Provincial Medical Products Administration, will be awarded in stages based on the progress of their research and development activities.
Article 10. Key Support for TCM R&D
1. For innovative TCMs, financial support amounting to 50% of the actual R&D expenses shall be provided. A maximum reward of 11 million yuan, 14 million yuan, 26 million yuan, and 40 million yuan shall be granted for obtaining clinical approvals and completing Phase I, II, and III clinical trials, respectively. Breakthrough therapy drugs that receive a drug registration certificate shall be awarded 15 million yuan. The annual total reward for each institution shall not exceed 150 million yuan.
2. For modified new TCMs, financial support amounting to 50% of the actual R&D expenses incurred shall be provided. A maximum reward of 3 million yuan, 4 million yuan, 14 million yuan, and 20 million yuan shall be awarded for obtaining clinical approvals and completing Phase I, II, and III clinical trials, respectively. The annual total reward for each institution shall not exceed 40 million yuan.
3. For complex-formulated TCM preparations derived from ancient classical formulas, financial support amounting to 50% of the actual R&D expenses incurred shall be granted, with a maximum reward of 6 million yuan for each product. The total annual reward for each institution shall not exceed 12 million yuan.
4. For TCMs with identical names and formulas, support will be provided at 50% of the actual R&D expenses, with a maximum reward of 500,000 yuan per product. The maximum annual reward for each institution shall not exceed 2.5 million yuan.
5. For TCM preparations prepared by medical institutions that obtain a registration number from the Guangdong Provincial Medical Products Administration or a record number for traditional TCM preparations, support will be provided at 50% of the actual R&D expenses, with a maximum reward of 300,000 yuan per product. The maximum annual reward for each institution (or entrusted R&D institution) shall not exceed 3 million yuan.
6. Support shall be provided for the research and formulation of new standards and processing specifications for TCM decoction pieces. For each standard recognized and included by the Guangdong Provincial Medical Products Administration, a reward of 120,000 yuan shall be granted; for standards recognized and included by national standards, a reward of 1.2 million yuan shall be granted. The maximum annual reward for each institution shall not exceed 5 million yuan.
Article 11. Support for R&D of Biologics and Chemical Drugs
1. Innovative biologics and chemical drugs shall receive 40% funding support based on the actual R&D expenses incurred. The maximum rewards for obtaining clinical approvals and completing Phase I, II, and III clinical trials are as follows: 10 million yuan, 12 million yuan, 24 million yuan, and 36 million yuan, respectively. For breakthrough therapy drugs that receive a drug registration certificate, a reward of 12 million yuan shall be granted. The total annual reward for each institution shall not exceed 120 million yuan.
2. Modified new drugs based on biologics and chemical medicines shall also receive 40% funding support based on the actual R&D expenses incurred. The maximum rewards for obtaining clinical approvals and completing Phase I, II, and III clinical trials are as follows: 2.4 million yuan, 3.6 million yuan, 12 million yuan, and 18 million yuan, respectively. The annual total subsidy for each institute shall not exceed 36 million yuan.
3. For drugs that are among the first three nationwide to pass generic drug consistency evaluations, a reward of up to 6 million yuan will be provided at 20% of the actual R&D expenses. The maximum annual reward for each institution shall not exceed 12 million yuan.
Article 12. Support for Medical Device R&D
For Class II and III medical devices (excluding Class II diagnostic reagents and device components) that first obtain a medical device registration certificate and hold invention patents, a reward of 40% of the actual R&D expenses incurred shall be granted, with a maximum reward of 3.6 million yuan for Class II devices and 6 million yuan for Class III devices. For those entering the special review process for innovative medical devices at the provincial or national levels, the reward amounts can be increased to 4 million yuan for Class II devices and 7 million yuan for Class III devices. The total annual reward for each institution shall not exceed 18 million yuan.
Article 13. Support for the R&D of Healthcare-related Products
1. For those who obtain a registration certificate for health foods, a reward of 40% of the actual R&D expenses incurred shall be granted, with a maximum reward of 600,000 yuan per registration certificate. The total annual reward for each institution shall not exceed 6 million yuan.
2. For those who obtain a registration certificate for formula food for special medical purposes, a reward of 40% of the actual R&D expenses (including clinical trial expenses) shall be provided, with a maximum reward of 2.4 million yuan for each product. The total annual reward for each institution shall not exceed 12 million yuan.
3. For those who obtain a registration certificate for special-use cosmetics from the NMPA, a reward of 40% of the actual R&D expenses shall be granted, with a maximum reward of 200,000 yuan for each registration certificate. The total annual reward for each institution shall not exceed 1 million yuan.
Chapter 5. Optimizing the Industrial Ecosystem
Article 14. Establishing Industrial Service Platforms
1. Support shall be provided for the development of the industry-education-research demonstration bases for Macao higher education institutions in the Cooperation Zone. Collaboration between Macao higher education institutions or their industry-education-research bases in the Cooperation Zone with enterprises, hospitals, and research institutes shall be encouraged to carry out transformation projects in biomedicine and healthcare-related industries. A subsidy of 50% of the operating costs for the base transformation projects shall be granted, with a maximum subsidy of 1 million yuan for each project. The total annual subsidy for each base shall not exceed 5 million yuan. For projects in biomedicine and healthcare-related industries funded by the Macao Government’s science and technology grants, a matching subsidy of up to 8 million yuan shall be provided, corresponding to 50% of the funding amount.
2. Support shall be provided for the establishment of key laboratories and engineering research centers in biomedicine and healthcare-related sectors at the provincial level or above within the Cooperation Zone. A subsidy of 50% of the total project investment shall be granted, with a maximum subsidy of 36 million yuan. For provincial-level or higher enterprise technology centers established in the Cooperation Zone, a subsidy of 50% of the total project investment shall be granted, with a maximum subsidy of 18 million yuan.
3. Support shall be provided for the construction of evidence-based evaluation systems that integrate TCM theory, application experience in humans, and clinical trials. This includes public service platforms that conduct TCM theoretical research, real-world studies (RWS), patient-focused drug development (PFDD), patient-reported outcomes (PRO), and research centers for TCM quality, safety, and standardization. A subsidy of up to 50% of the total project investment, with a maximum of 60 million yuan, shall be provided.
4. Support shall be provided to develop Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs). This includes establishing specialized technical service platforms for drug screening, synthesis, toxicology research, efficacy evaluation, laboratory animal services, new drug applications, third-party testing, industrial pilot production, Marketing Authorization Holder (MAH) comprehensive services, and drug R&D big data services, with a subsidy of 40% of the total project investment granted, up to 60 million yuan.
5. Established public service and specialized technical platforms in the biomedicine and healthcare-related sector shall receive a subsidy equivalent to 20% of the actual service amount rendered to institutions in the Cooperation Zone (not having an investment relationship with the platform) for the previous year, with a maximum annual subsidy of 1.2 million yuan. For institutions in the Cooperation Zone utilizing services from the aforementioned platforms, a subsidy of 50% of the actual service amount shall be granted, with each institution’s total annual subsidy not exceeding 2.4 million yuan.
6. Clinical medical institutions that obtain National Good Clinical Practice (GCP) certification shall receive a reward of 40% of the total project investment, with a maximum reward of 6 million yuan. An additional 600,000 yuan shall be granted for each newly added GCP specialty. The total annual reward for each institution shall not exceed 12 million yuan.
7. Support shall be provided for introducing, planning and organizing academic conferences, professional forums, summit meetings, and exhibitions in biomedicine and healthcare-related industries at the provincial level or above. For qualified activities, a subsidy of 40% of the actual expenses incurred shall be granted, with a maximum subsidy of 6 million yuan for each event. For industry associations with significant influence established in the Cooperation Zone, starting from the second year after establishment, an annual subsidy of up to 1 million yuan shall be provided based on the activities conducted in the previous year.
Article 15. Supporting Talent Introduction and Cultivation
1. Providing Talent Introduction Subsidy: A one-time talent introduction subsidy shall be provided to institutions that have newly introduced “high-end, professional, and urgently needed” research and development personnel who work in the Cooperation Zone and have signed labor contracts for three years or more. The subsidy shall amount to 10% of the annual personnel costs, with a maximum annual subsidy of 2.4 million yuan per institution.
2. Supporting the Development of Talent Training Bases: Support shall be provided for institutions within the Cooperation Zone to establish training bases for talent in the biomedicine and healthcare-related industries. Training may cover R&D techniques, manufacturing processes, regulatory and registration policies, corporate management, intellectual property protection, and investment and financing. A subsidy of up to 50% of the actual training expenses, with a maximum annual subsidy of 1 million yuan, shall be provided.
Article 16. Optimizing Specialized Park Services
1. Providing Rent Subsidy: Institutions that sign lease agreements with a term of no less than three years will be eligible for rental subsidies according to the relevant policies of the Cooperation Zone. During the period in which the subsidy is received, the institution is prohibited from subleasing or changing the use of the premises.
2. Green Industrial Development: Specialized parks are encouraged to construct hazardous waste treatment facilities. A subsidy of up to 30% of the construction costs, with a maximum of 2.4 million yuan, shall be provided. Support shall also be provided for institutions within the Cooperation Zone that commission specialized agencies for medical waste disposal, with a subsidy of 50% of the actual service fees, limited to a maximum annual subsidy of 200,000 yuan for each institution.
Article 17. Supplementary Provisions
1. These Measures shall come into force on January 01, 2022, and remain in force until December 31, 2024.
2. In the event of any conflict between these Measures and national laws or regulations, or relevant provisions of Guangdong Province, the latter shall prevail.
3. The Executive Committee of the Cooperation Zone shall be responsible for interpreting these Measures. The Economic Development Bureau of the Cooperation Zone shall be responsible for formulating the implementation details and organizing the execution of these Measures.