（April 16, 2021）

  SMPG GO G〔2021〕No.5

Attention: all District People's Governments, and all relevant Commissions, Offices and Bureaus of the Municipal People’s Government: 

With a view to further playing the leading role of the biomedical industry, accelerating the construction of an innovative highland of the biomedical industry with international influence, and endeavoring at full strength to build a world-class biomedical industry cluster, we hereby put forward the following opinions on promoting the high-quality development of the municipal biomedical industry with the approval of the Municipal People’s Government: 

 

IDefineGeneralRequirements

1. Main Objectives

We shall, based on the development foundation of Shanghai biomedicine industry, focus on the breakthrough of advantageous areas, innovate source guidance, prioritize regional development and ecological environment construction, and forge leading enterprises; we shall establish a policy - supporting system of "research + clinical study + manufacturing + application" for the whole industry chain, perfect the "1 + 5 + X" new layout for the biomedicine industry bases, implement high quality development of major industry projects and strive to reach 180 billion yuan RMB in the total annual industrial output value in the biomedical manufacturing industry of the whole Municipality through three - year efforts.

2. Supported Areas. Pharmaceutical field mainly include antibody drugs, new vaccines, gene therapy, cell therapy and other high-end biological products, innovative chemical drugs and high-end preparations, modern Chinese medicine, etc. High-end medical devices mainly include high-end imaging equipment, high-end implant interventional devices and consumables, surgical treatment and life support equipment, high-end rehabilitation assistive devices, in vitro diagnostic instruments and reagents, biomedical materials, etc. Advanced equipment and materials mainly include precision scientific research instruments, pharmaceutical equipment and high-end raw materials in the field of life science. Other areas include new service outsourcing, digital medical (pharmaceutical) products and services, etc.

3. Supported objects. Enterprises or public institutions or private non-enterprise units registered within this Municipality that are engaged in the research and development, production and professional services in the fields of drugs, medical instruments, scientific research instruments of biotechnology and life science. Priority support will be given to products, platforms and projects that have high technological content, good application prospects, strong demonstration role and are at key links in the industrial chain.

II Uplift Innovative Source Guidance Abilities

1.Building a national strategic platform for scientific and technological innovation

We shall actively undertake major national development strategic tasks, build a strategic platform for national pharmaceutical science and technology innovation by relying on key units, strengthen high-level basic research in frontier fields around new targets, new sites, new mechanisms and new molecular entities, and strive for the landing of several national major scientific and technological infrastructure projects and high-level biosafety laboratories. (Responsible units: Municipal Science and Technology Commission, Municipal Health Commission, Municipal Development and Reform Commission)

2. Deploy municipal-level major science and technology projects and innovation research institutions. We shall focus on basic frontier areas of life sciences, continue to deploy a number of major science and technology projects at the municipal level, and encourage key enterprises in scientific and technological innovation to tackle related key tasks. We shall focus on key areas such as prevention & control of major infectious diseases and biological safety, support relevant institutions to integrate their superior research forces to build a number of influential innovative research institutions. (Responsible units: Municipal Science and Technology Commission, Municipal Health Commission, Municipal Development and Reform Commission, Municipal Finance Bureau)

III Strengthen Support for Research and Development of Innovative Products

1.Support the research and development of innovative drugs. The 1st categories of chemical medicine, biological products and traditional Chinese medicine that are in the process of domestic clinical trials at Phase 1, Phase 2, Phase 3 and are manufactured by the registered applicants in this Municipality with the production permit shall be granted the fund support no more than 40% of R&D spending by its superiority in accordance with different phases of clinical trials, up to 5 million yuan, 10 million yuan, 30 million yuan maximum respectively. The accumulative support quota for each unit shall not exceed 100 million yuan RMB per year. (Responsible units: Municipal Science and Technology Commission, Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau)

2. Support research and development of improved new drugs. The improved new drugs with high technical content and obvious advantages in safety and effectiveness that have completed the domestic clinical trials of Phase 2, Phase 3 and manufactured in this Municipality by the local registered applicants with the production permit shall be granted the fund support no more than 20% of R&D spending by its superiority, up to 5 million yuan RMB, 10 million yuan, 30 million yuan maximum respectively. The annual accumulative support quota of each unit shall not exceed 20 million yuan RMB. (Responsible units: Municipal Science and Technology Commission, Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau)

3. Support the research and development of innovative medical devices. The medical device products that have entered the special examination procedure of national and municipal innovative medical device will be granted the fund support of no more than 2 million yuan RMB; the products that have entered the above procedures and obtained the registration certificate of medical devices for the first time and are manufactured in this Municipality will be re-granted no more than 40% of the R&D spending, up to 5 million yuan RMB maximum; the annual accumulative support quota of each unit shall not exceed 15 million yuan RMB. (Responsible units: Municipal Science and Technology Commission, Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau)

4. Facilitate Customs clearance of R&D goods and special goods. We shall establish a multi-department joint assessment and supervision mechanism for the import of R&D goods, set up an information exchange and supervision platform covering the whole process of Customs clearance, formulate a "white list" of municipal biomedical pilot enterprises and products, and simplify the pre-approval procedures for related goods of enterprises within the list for their easy customs clearance. The joint supervision mechanism for entry and exit of special goods will be promoted on a pilot basis throughout this Municipality to strengthen safety supervision. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Commission of Commerce, Shanghai Customs, Municipal Drug Supervision Administration, Municipal Commission of Science and Technology, Shanghai Science and Technology Office)

5. Support the exploitation of overseas markets. The innovative drugs and high-end medical devices researched and developed in this Municipality that have completed the registration in the international agencies as FDA (Food and Drug Supervision Administration USA), the EMA (EuropeanMedicines Agency), CE (Communate Europpene), PMDA (Pharmaceuticals and Medical Devices Agency) or the WHO (World Health Organization), and achieve sales in the relevant foreign markets, shall be granted, through assessment and selection, the fund support of no more than 30% of the R&D spending, up to 10 million yuan RMBmaximum at one-time. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau)

IV Strengthen Clinical Research Transformation and Hospital-Enterprise Coordination

1. Strengthen incentives for the transformation of clinical research achievements. We shall, relying on the "Action Plan for Promoting Clinical Skills and Clinical Innovation in Municipal –level Hospitals", support relevant hospitals in carrying out clinical research and achievements transformation. The identified clinical research beds shall not be included in the beds management of medical institutions, and the evaluation of the efficiency, turnover rate and utilization rate of the beds shall not be managed. For the medical personnel who have made major contributions to the transformation of clinical research achievements, the cash rewards for the transformation of scientific and technological achievements at their posts are allowed to be included in the total amount of performance salary of the current year, but are not restricted by the total amount and not included in the total base. (Responsible units: Shenkang Hospital Development Center, Municipal Health Commission, Municipal Human Resources and Social Security Bureau, Municipal Finance Bureau)

2. Establish a working mechanism of hospital ethics collaboration review. A collaborative review mechanism of ethics committees of hospitals in this Municipality shall be established to carry out ethical review of multi-center clinical research collaboration. The ethics committees of all hospitals that sign the collaborative review agreement can explore the implementation of mutual recognition of ethical review results for multi-center clinical studies in accordance with relevant national rules and guidelines. (Responsible units: Municipal Health Commission, Municipal Drug Supervision Administration, Shenkang Hospital Development Center)

3. Improve the system of clinical research support platform. We shall unify the information collection standards of the municipal clinical bio-bank, realize the sharing mechanism of data collection and sample optimization. We shall formulate the classification standards for health big data openness, build medical big data access infrastructure, and promote the orderly openness of clinical data to enterprises. We shall, relying on high-level biosafety laboratories, strengthen the capabilities of building bacterial strain banks, and initiate construction of special disease database at municipal level. (Responsible units: Municipal Health Commission, Municipal Science and Technology Commission, Shenkang Hospital Development Center, Municipal Commission of Economy and Informatization, Municipal Finance Bureau)

4. Improve the innovation capabilities of the integration of industry and hospitals. We shall establish a demonstration base for industry-hospital integration and a mechanism for hospital-enterprise collaboration, and improve a research and innovation platform for cooperation between hospitals and enterprises in municipal hospitals as well as a platform for digital management of clinical trials. We shall support qualified institutions in building research hospitals and jointly establish technology transfer platforms with enterprises. We shall support research hospitals in carrying out trials of self-made in vitro diagnostic reagents and expand compassionate use of clinical trial drugs, support qualified medical institutions to set up clinical research centers in hospitals, support the renovation and construction of demonstrative research wards. (Responsible units: Municipal Commission of Economy and Informatization,Municipal Health Commission, Shenkang Hospital Development Center, Municipal Science and Technology Commission, Municipal Drug Supervision Administration, Municipal Finance Bureau)

V Reinforce the brand of "R & D in Zhangjiang + Made in Shanghai"

1. Uplift modernization level for industrial chains. For core technology research, key professional service platform construction and major product industrialization projects in the field of biomedicine, the fund support no more than 30% of new investment will be granted, up to 15 million yuan RMB maximum. Major projects that are listed in the special development directory of the strategic emerging industries within this Municipality will be granted the highest fund support of 100 million yuan RMB. This Municipality will continue to support the research and development of drugs and medical devices, relying on the Municipal Science and Technology Innovation Action Plan. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Development and Reform Commission, Municipal Commission of Science and Technology, Municipal Finance Bureau)

2. Promote the manufacturing industry in digital, intelligent and green transformation. For the purpose of promoting the deep integration of the new generation of information technology and manufacturing industry, the fund support of no more than 20% of the total investment or contracted amount of the approved project will be granted, up to 10 million yuan RMB maximum. Enterprises are encouraged to strengthen high-end, intelligent and green transformation, and will be granted the fund support no more than 10% of the total investment of the approved project, up to 50 million yuan RMB maximum. We shall promote research on evaluation standards for continuous pharmaceutical manufacturing, popularize technology application demonstrations, and encourage the development of green and miniaturized production equipment and processes such as micro-reactors. (Responsible units:Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau)

3. Promote new modes of contracted research, development and production organization. It is encouraged to entrust the Contracted Manufacturing Organization (CMO) or Contracted Development &Manufacturing Organization (CDMO) to carry out R&D and production activities, the single variety manufactured by the entrusting enterprise (the entrusting parties shall have no investment connection) will be granted 20% of the initial contracted amount in fund support, up to 5 million yuan RMB maximum. The highest annual subsidy for a single enterprise shall not exceed 10 million yuan. Eligible TCM manufacturing enterprises in this Municipality are allowed to conduct scientific research, production and clinical use of TCM formula granules, and encouraged to engage in the construction of TCM standardization system. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, Municipal Finance Bureau, Municipal Commission of Health and Health, Municipal Bureau of Medical Insurance)

4. Steadily increase the carrying capacity of industrial space. The relevant district people’s government shall quantify the spatial indicators of industries and properties newly launched in the municipal featured biomedicine parks in the next 3-5 years, and the Municipal Biomedicine Industry Development Leading Group (hereinafter referred to as the "Leading Group") shall carry out annual assessment on the implementation of the indicators. Under the premise of conforming to the industrial function orientation and the leading industrial use for projects, the Zhangjiang Science City and Lingang New Special Zone shall allow the transferees to independently determine the industrial use proportion of the land. (Responsible units: Relevant District People’s Governments, Leading Group Office, Municipal Planning and Resources Bureau, Municipal Ecological Environment Bureau, Shanghai Science and Technology Office, Lingang New Special Zone Management Committee)

5. Optimize the access management of biomedical environment. For featured biomedicine parks that meet the requirements, we shall accelerate the linkage between planning EIA and projectEIA, and simplify the EIA handling process. Municipal major industrial projects will have an access to green approval channels, and the total pollutant emission quota will be adjusted from three-level allocation to overall planning of the whole region or the whole Municipality. Districts are encouraged to subsidize the professional institutions that deal with hazardous wastes in biomedical parks in accordance with the amount of hazardous wastes disposed. (Responsible units: Municipal Bureau of Ecology and Environment, Municipal Commission of Economy and Informatization, Municipal Drug Supervision Administration, and Relevant District Governments)

6. Promote the parks’ specialized development and inter-district cooperation. We shall optimize the layout of biomedical industrial bases, focus on building Zhangjiang biomedical industrial cluster led by "Zhangjiang Pharmaceutical Valley", continue to build the five industrial development clusters of Lingang New Special Zone, Fengxian, Jinshan, Baoshan, Minhang, and cultivate featured industrial carriers in Xuhui, Songjiang, Qingpu, Jiading, Putuo districts. We shall strengthen the guidance and coordination of cross-district industrial cooperation projects, accelerate the construction of a whole - chain industrial information platform, explore and improve the district cooperation and benefit sharing mechanism. (Responsible units: Leading Group Office, Municipal Science and Technology Commission, Municipal Planning and Resources Bureau, Shanghai Science and Technology Office, Municipal Drug Supervision Administration, Municipal Health Commission, Shenkang Hospital Development Center, and Relevant District People’s Governments)

VI. Accelerate the Application and Promotion of Innovative Products

I. Optimize the admission process of innovative products. The registered and listed products of medical devices that have been included in the special examination procedure for national or municipal innovative medical devices and are confirmed to be additionally charged can directly get the municipal charging code and be listed and purchased through the network of Sunshine Platform. The Municipal Committee for Pharmaceutical Administration and Pharmacotherapeutics of Medical Institutions shall be established to provide technical support for the pharmaceutical administration and pharmaceutical care in this Municipality. Medical institutions shall be organized to set up the management committee of medical devices clinical use and be responsible for guiding and supervising the clinical use of medical devices. (Responsible units: Municipal Medical Insurance Bureau, Municipal Drug Supervision Administration, Municipal Health Commission, Shenkang Hospital Development Center)

2. Support the application demonstration of innovative products. The government shall be the first to purchase and order the innovative products listed in the "Shanghai Innovative Products Recommend Catalogue". The initial purchasing power for innovative medical equipment shall be increased and the share of government procurement be raised. For the first set of high-end medical devices and the first batch of new materials, the fund support of no more than 20% of the sales contract amount will be granted, up to 30 million yuan RMB and 3 million yuan maximum respectively. The re-evaluation of innovative products after they are launched will be supported. (Responsible units:Municipal Commission of Economy and Informatization, Municipal Health Commission, Municipal Finance Bureau)

3. Launch a pilot program to purchase services for AI-assisted diagnostic systems. Pilot hospitals are allowed to purchase technical services of AI-assisted diagnostic systems with registration certificates of medical devices Class 3 from service providers through agreement. Pilot hospitals when purchasing services should carry out health economics evaluation on clinical application effect, pay service providers by the number of times for system use, and control the total amount of annual payment. (Responsible units: Shenkang Hospital Development Center, Municipal Health Commission, Municipal Drug Supervision Administration, Municipal Commission of Economy and Informatization, Municipal Finance Bureau)

4. Strengthen the support of the medical insurance system for the application of innovative products. We shall strive to include all kinds of innovative products in the national regular drug list or the drug list under negotiation. We shall include qualified diagnosis and treatment items and medical supplies in the municipal medical insurance directory, improve the face-to-face mechanism between medical insurance and enterprises, give full play to the role of financial services such as commercial insurance in this Municipality, build a multi-tiered medical security system, enrich the supply of medical insurance products, and speed up efforts to benefit more people in need. (Responsible units: Municipal Medical Insurance Bureau, Municipal Health Commission, Municipal Commission of Economy and Informatization, Shenkang Hospital Development Center)

VII. Implement the Three-year Action Plan in Building up a World-class Biomedical Industry Cluster

1. Implement major projects for high-quality industrial development. Focus shall be placed on the eight major projects of high quality industry development such as construction of major basic scientific research platform, industrial core technology research, innovation service carrier construction, clinical transformation ability elevation, industrial chain supplement, consolidation and enhancement, advanced manufacturing level uplifting, industrial spatial capacity increase, innovative product promotion and so on, speed up the world-class industrial clusters. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Commission of Science and Technology, Municipal Development and Reform Commission and other related units)

2. Improve the service system for industrial innovation. We will hold international high-level industry conference, support the development of various biomedical professional service institutions and organizations. The construction projects of incubators and accelerators in the field of biomedicine will be supported with interest subsidy in accordance with the relevant policies for the municipal new infrastructure construction."Housekeeping" personalized service and precise support will be provided for all kinds of enterprises. A digital regulatory platform for drugs and medical devices shall be set up to improve regulatory efficiency. A workstation for product registration guidance and service will be established in biomedicine industry-related parks to improve the efficiency of registration review. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Commission of Science and Technology, Municipal Development and Reform Commission, Shanghai Science and Technology Foundation, Municipal Drug Supervision Administration)

3. Foster and expand leading enterprises and innovation-oriented enterprises. We shall support leading enterprises in the Municipality to strengthen capital operation and mode innovation, strengthen research and development leadership and manufacturing support, and promote global development. We shall encourage biomedical enterprises in this Municipality to develop and expand through independent innovation, acquisition and merger. We shall strengthen investment attraction and attract high-quality enterprises at home and abroad to set up various headquarters, research and development centers and production bases in Shanghai. We shall encourage the districts of municipal featured biomedicine parks to put in place the specialized policies to promote the development of leading enterprises. We shall support innovative development of supply chain service enterprises in the field of biomedicine. (Responsible units: Municipal Commission of Economy and Informatization, Municipal Commission of Commerce, Municipal State-owned Assets Supervision and Administration Commission, and relevant district people’s governments)

4. Build a talent highland. We shall formulate a list of key bio-pharmaceutical enterprises in this Municipality, implement dynamic management, and enclose key enterprises in the key support scope of the institutions that may directly settle the introduced talents in this Municipality. The qualified high-level talents introduced or recommended by key enterprises after the examination and approval of the Leading Group Office shall be recommended to the Municipal Talent Office, and the application of various talent cultivation plans will be supported. We shall deepen pilots programs to integrate industry with education, and support key biomedicine enterprises to develop bases for training highly skilled personnel. (Responsible units: Leading Group Office, Organization Department of CPC Municipal Committee, Municipal Human Resources and Social Security Bureau, Municipal Public Security Bureau, Municipal Development and Reform Commission)

5. Innovate industrial financial service modes. We shall continue to promote the listing and financing of biomedical enterprises on the Science and Technology Innovation Board, give full play to the role of policy-based guarantee funds in this Municipality and support pilot projects to innovate financial products such as loans for new drugs. We shall continue to expand the scale of Shanghai biomedical industry equity investment fund and simplify relevant subject registration procedures when an accredited venture capital institution initiates or funds a biomedical fund as a limited partner. When eligible state-owned venture capital institutions participate in market investment projects by adopting benchmark market valuation, they shall be allowed to handle the record of state-owned assets assessment afterwards. (Responsible units: Municipal Local Financial Supervision Bureau, Municipal Commission of Economy and Informatization, Municipal Finance Bureau, Municipal Market Regulation Bureau, Municipal Development and Reform Commission, Municipal State-owned Assets Supervision and Administration Commission)

These Opinions shall be effective as of June 1, 2021 and remain valid until May 31, 2024. In case these Opinions are overlapping with other similar policy opinions of this Municipality, they shall be supported in accordance with the principle of "preferential, superior and no repetition".