Original Title: Several Opinions of the General Office of the Shanghai Municipal People’s Government on Supporting Innovation and Development Across the Entire Value Chain of the Biopharmaceutical Industry
Shanghai Municipal Government General Office Regulation [2024] No. 9
To the People’s Governments of All Districts, and All Commissions, Offices, and Bureaus of the Municipal Government:
The development of the biopharmaceutical industry is a key driver for accelerating the formation of new-quality productive forces. To further establish Shanghai as a global hub for major strategic biopharmaceutical industries in the new era and to support the city’s high-quality economic and social development, the following opinions are hereby put forward regarding supporting the innovative development of the entire biopharmaceutical industry chain:
I. Significantly Enhancing Innovation Capabilities
(1) Accelerate innovation in fundamental theories and breakthroughs in cutting-edge technologies. Leverage the role of innovation platforms such as the National Strategic Science and Technology Forces, target fundamental and frontier fields as well as emerging sectors such as cell and gene therapy, mRNA, synthetic biology, and regenerative medicine, conduct research on new targets, mechanisms, and structures, and plan for the development of cutting-edge technologies and novel drugs. Strengthen the research and development of high-end medical devices, advanced pharmaceutical equipment and materials, and modern traditional Chinese medicine.(Responsible Units: Municipal Science and Technology Commission, Municipal Development and Reform Commission)
(2) Support the application of artificial intelligence (AI) to empower drug R&D. Fully leverage technologies such as generative AI and deep learning, focusing on key stages including new drug target identification and validation, drug discovery and design, novel drug screening, and drug safety analysis. Accelerate breakthroughs in models, algorithms, and specialized software, as well as the development of common platforms, and conduct demonstration projects for intelligent application scenarios. (Responsible Units: Municipal Science and Technology Commission, Municipal Commission of Economy and Information Technology, Municipal Development and Reform Commission)
(3) Support programs for leading scientists and outstanding young talents. Support world-class scientists and master-level figures with core intellectual property (IP) to pursue disruptive theoretical and technological breakthroughs in Shanghai, providing support on a case-by-case basis. Prioritize support for outstanding young talents in basic research pilot zones and various talent programs. (Responsible Units: Municipal Talent Bureau, Municipal Science and Technology Commission, Municipal Commission of Economy and Information Technology)
(4) Accelerate the translation of scientific research outcomes into preclinical studies. Establish an interest subsidy support mechanism with performance metrics such as the number of drug clinical trial approvals obtained and the number of locally translated research outcomes. Encourage Contract Research Organizations (CROs) to provide preclinical research services for new drugs to universities and research institutes, with annual interest subsidies of up to 10 million yuan per project provided in accordance with regulations. Encourage enterprises to take the lead in establishing multi-stakeholder, full-chain innovation and translation consortia.(Responsible Units: Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau)
(5) Continuously increase support for innovative drug R&D. For Class 1 new drugs for which domestic Phase I, II, and III clinical trials are conducted by local registrants and result in tangible outcomes, support of up to 40% of R&D investment—capped at 10 million, 20 million, and 30 million yuan respectively—will be provided on a competitive basis for different stages in accordance with regulations;For Class 1 new drugs in cell and gene therapy that require only early-stage and confirmatory clinical trials, support of up to 15 million yuan and 30 million yuan, respectively, will be provided on a competitive basis in accordance with regulations. The cumulative annual support amount for each entity shall not exceed 100 million yuan. (Responsible Units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Finance Bureau)
(6) Continue to increase support for the development of innovative medical devices. For products entering the national or municipal special review procedure for innovative medical devices, support of up to 3 million yuan will be provided in accordance with regulations; for such products that obtain their first registration certificate and commence production, additional support of up to 40% of R&D investment, with a maximum of 8 million yuan, will be provided in accordance with regulations. The cumulative annual support amount for each entity is capped at 30 million yuan. (Responsible Units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal Drug Administration, Municipal Finance Bureau)
II. Promoting the Better Utilization of Clinical Resources to Empower Industrial Development
(7) Support the development of research-oriented hospitals.Advance the development of Shanghai Clinical Research Centers. Promote the transformation of qualified high-level hospitals into research-oriented hospitals with clinical innovation research as their primary function. Encourage the allocation of 10% of approved beds as research beds and the establishment of fully functional, integrated, and shared research wards. Encourage private capital to invest in the construction of research-oriented hospitals. (Responsible Units: Municipal Health Commission, Shenkang Hospital Development Center, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau)
(8) Optimize and improve the mechanism for clinical research translation. Leverage the role of the Shanghai Institute of Clinical Innovation and Translation, allowing hospitals to transfer equity shares formed by contributing intangible assets as capital to the Institute for holding on their behalf and to receive corresponding equity returns. Implement the third round of the “Three-Year Action Plan to Promote Clinical Skills and Clinical Innovation in Municipal Hospitals,” support high-level hospitals in conducting medical innovation and research translation, and support eligible hospital researchers in initiating high-level clinical research.(Responsible Units: Shanghai Hospital Development Center, Municipal Health Commission, Municipal Science and Technology Commission, Municipal State-owned Assets Supervision and Administration Commission, Municipal Finance Bureau)
(9) Shorten the time required to initiate clinical trials. Coordinate and aggregate citywide health and medical data to build foundational databases for relevant cohorts, and establish high-quality, high-standard biobanking facilities and management systems. Create preparatory cohorts for clinical trials targeting major diseases such as cancer, cardiovascular and cerebrovascular diseases, metabolic disorders, and psychiatric and neurological conditions to facilitate rapid enrollment of trial participants. Strive to reduce the total time required for internal procedures at medical institutions prior to the initiation of clinical trials to within 25 weeks.(Responsible Units: Municipal Health Commission, Shanghai Kang Hospital Development Center, Municipal Data Bureau, Municipal Science and Technology Commission, Municipal Finance Bureau)
(10) Improve the efficiency of medical ethics review. Establish a “single set of materials, single submission” mechanism for ethics review, and conduct the preliminary review by the project management department, the formal ethics review, and the contract preliminary review in parallel.Improve the efficiency and frequency of ethics review meetings; the lead institution (primary reviewer) shall conduct the review and issue an opinion within 15 working days of acceptance, while participating institutions using the simplified review procedure shall do so within 5 working days of acceptance, with the goal of reducing the overall ethics review process to within 3 weeks.Encourage participating institutions in multicenter clinical research (trials) to proactively recognize the ethical review results of the lead institution, and continue to promote the mutual recognition of medical ethics review results across the city. (Responsible Units: Municipal Health Commission, Municipal Drug Administration, ShenKang Hospital Development Center)
(11) Establish an incentive mechanism for clinical trial teams at medical institutions. Promote the improvement of compensation distribution mechanisms for clinical trial teams at medical institutions, and support the use of clinical research work and its outcomes as important references for professional title evaluations, position competitions, and performance appraisals. Allow eligible clinical trial projects led by principal investigators to be treated as municipal-level research projects. (Responsible Units: Municipal Health Commission, Municipal Human Resources and Social Security Bureau, Municipal Science and Technology Commission, ShenKang Hospital Development Center)
(12) Conduct high-level clinical trial projects in accordance with international standards. Support eligible Contract Research Organizations (CROs) in implementing projects to enhance their clinical trial service capabilities in accordance with international standards, providing up to 1 million yuan in funding per project on a competitive basis in accordance with regulations. For high-level clinical trial projects for innovative products conducted overseas, provide up to 20 million yuan in funding on a competitive basis in accordance with regulations.The cumulative annual support for each entity shall not exceed 100 million yuan. (Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Finance Bureau, ShenKang Hospital Development Center)
(13) Improve the clinical trial liability and risk compensation mechanism. Encourage insurance institutions to develop liability insurance products for domestic clinical trials and products, as well as for overseas clinical trials and high-end medical equipment. In accordance with regulations, provide support to insured enterprises equivalent to 50% of the actual premiums paid, with a maximum of 500,000 yuan and 1 million yuan, respectively. (Responsible Units: Municipal Science and Technology Commission, Shanghai Financial Regulatory Bureau, Municipal Drug Administration, Municipal Finance Bureau)
III. Accelerating Review and Approval Processes
(14) Seek national support for registration review. Promote the implementation of national reform pilot programs to reduce the review period for drug supplemental applications to 60 working days and the review and approval period for drug clinical trial applications to 30 working days. Support capacity building at the Yangtze River Delta Branch of the National Medical Products Administration’s Drug and Medical Device Review and Inspection Center to enable it to play a greater role in the acceptance, review, and inspection of products in key areas. Accelerate research on detailed guidelines for continuous manufacturing processes.(Responsible Units: Municipal Drug Administration, Municipal Science and Technology Commission)
(15) Strengthen proactive guidance services for registration review. Focusing on key R&D products and projects, implement a dedicated team guidance mechanism within drug regulatory departments to provide proactive service coordination at critical stages such as clinical research, production licensing, marketing authorization, and inspection and testing;Implement measures such as pre-inspection and pre-review, fully online processing, immediate review upon submission, and smart review; prioritize registration sampling and GMP compliance inspections for key R&D pharmaceuticals; and provide services such as pre-review of application materials and priority scheduling of registration testing for key R&D Class III medical devices. (Responsible Units: Municipal Drug Administration, Municipal Science and Technology Commission, Municipal Health Commission)
(16) Accelerate the registration review of Class II medical devices. For Class II medical devices with clear clinical value and strong innovation, encourage the application for special review procedures, and prioritize registration testing, technical review, and registration system verification; medical device products that are the first of their kind nationwide or meet priority approval criteria shall be handled accordingly. The average review time for Class II medical devices shall be reduced to within 40 working days. (Responsible Unit: Municipal Drug Administration)
(17) Enhance the service capacity for drug and medical device registration testing. Support drug and medical device testing and inspection institutions in strengthening the development of specialized technical service platforms for biological products, implantable medical devices, large-scale medical equipment, and medical software, providing enterprises with services such as product safety evaluation, quality control, registration and filing, risk assessment, testing and inspection, and technical training. (Responsible Units: Municipal Drug Administration, Municipal Science and Technology Commission, Municipal Development and Reform Commission)
IV. Accelerating the Application and Promotion of Innovative Products
(18) Encourage the procurement and use of innovative products in hospitals. Continuously update the “New and Superior Drugs and Medical Devices” product catalog, establish a “green channel” for listing innovative drugs and medical devices online, and recommend their inclusion in the coverage scope of the National Medical Insurance Drug List or the “Shanghai Huibao” insurance program. Within one month of the release of updates to the National Medical Insurance Drug List and the “New and Superior Drugs and Medical Devices” catalog, medical institutions in our city shall procure and use the corresponding innovative drugs and medical devices based on clinical needs and hospital specialties, adhering to the principle of “procuring all that should be procured.”Promptly include eligible pharmacies within the scope of the “dual-channel” system. Strengthen performance evaluations of municipal hospitals regarding innovation responsibilities; medical institutions shall not restrict the adoption of innovative drugs and medical devices in hospitals based on factors such as drug usage volume or the proportion of drugs and consumables in total costs. (Responsible Units: Municipal Science and Technology Commission, Municipal Medical Insurance Bureau, Municipal Health Commission, ShenKang Hospital Development Center, Shanghai Financial Regulatory Bureau)
(19) Increase support for medical insurance reimbursement of innovative products. For diagnostic and treatment items related to nationally negotiated medicines and innovative medical devices, implement separate budget allocations for medical insurance reimbursement and treat them as distinct categories in DRG/DIP reforms; for eligible high-value innovative medical devices and innovative medical service items, establish independent groups within DRG/DIP reforms, raise reimbursement standards, and exempt them from restrictions on the number of high-multiplier cases.For “new and superior” drug and medical device products that meet the relevant regulations, promptly study their inclusion in the scope of medical insurance coverage. (Responsible Units: Municipal Medical Insurance Bureau, Municipal Health Commission, Municipal Drug Administration, Municipal Science and Technology Commission, Shenkang Hospital Development Center)
(20) Support the demonstration and promotion of innovative products. Support medical institutions in collaborating with enterprises to carry out demonstration projects for the application of innovative medical devices and pharmaceuticals, and to conduct post-market evaluations, real-world efficacy assessments, and research on expanding indications. In accordance with regulations, provide up to 2 million yuan in support to each project on a merit-based selection basis. Support collaborative innovation in government procurement within the biomedical sector.(Responsible Units: Municipal Science and Technology Commission, Municipal Finance Bureau, Municipal Drug Administration, Shanghai Financial Regulatory Bureau, Municipal Health Commission, Municipal Medical Insurance Bureau, Shanghai Hospital Development Center)
V. Strengthening Enterprise Services and Support for Industrialization
(21) Establish a mechanism for coordinating and resolving enterprise development issues. Relying on dedicated task forces at the municipal and district levels, focus on 100 key enterprises, 100 major investment projects, 100 key products, and 100 key pipelines to establish a system for coordinating and resolving the “4×100” issue list. Relying on the Municipal Strategic Advisory Committee on Industry-Medicine Integration, build a communication platform connecting government, industry, academia, research, finance, and service sectors.(Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Health Commission, relevant district governments)
(22) Vigorously Cultivate Blockbuster Products. Provide guidance and support for innovative products developed in Shanghai that achieve commercial output and surpass relevant output value and scale thresholds for the first time. Leverage the role of state-owned investment funds, strengthen policy support at the municipal and district levels, and encourage the expansion of market scale for relevant products. (Responsible Units: Municipal Science and Technology Commission, Municipal Development and Reform Commission, Municipal State-owned Assets Supervision and Administration Commission, Municipal Finance Bureau, relevant district governments)
(23) Accelerate the advancement of major industrialization projects. Support the construction of projects such as process technology R&D, specialized technical service platforms, and industrialization bases; provide support of up to 30% of the approved new investment based on merit in accordance with regulations. Encourage enterprises to accelerate high-end, intelligent, and green transformation; provide support of up to 10% of the approved total project investment based on merit in accordance with regulations. The maximum support for both of the above items is 100 million yuan.(Responsible Units: Municipal Science and Technology Commission, Municipal Commission of Economy and Information Technology, Municipal Development and Reform Commission)
(24) Promote new models of Contract Research and Manufacturing Organizations (CMOs). Support Contract Research and Manufacturing Organizations (CMOs) and manufacturing enterprises with mature production experience in undertaking contract manufacturing activities (where the contracting parties have no investment or other affiliations). In accordance with regulations, provide support to the contractor amounting to no more than 10% of the annual contract manufacturing output value, with a maximum of 5 million yuan per product and 10 million yuan per enterprise annually. (Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Finance Bureau)
(25) Strengthen support for industrial implementation and coordination. Establish a municipal-district industrial coordination mechanism, enhance municipal-level planning and coordination, and promote inter-district collaboration, information sharing, and complementary resource utilization. Provide 5 million square meters of standardized biopharmaceutical production facilities and support eligible projects in implementing “industrial vertical integration.”Encourage state-owned park management companies to develop and strengthen investment and financing operations, while de-emphasizing performance metrics such as rent and profit. (Responsible Units: Municipal Science and Technology Commission, Municipal Commission of Economy and Information Technology, Municipal State-owned Assets Supervision and Administration Commission, relevant district governments)
VI. Strengthening Investment and Financing Support
(26) Cultivate medium- and long-term investors and patient capital. Leverage the roles of the Shanghai Biomedical Industry Mother Fund, the Biomedical Industry Equity Investment Fund, and the Biomedical Innovation and Commercialization Fund to strengthen strategic rescue investments in promising enterprises and high-quality R&D pipelines. Encourage government-guided funds to “invest early, invest in small-scale projects, and invest in hard technology.”Study the establishment of long-term performance evaluation and error-tolerance mechanisms for projects funded by state-owned funds. (Responsible Units: Municipal SASAC, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau, Municipal Party Committee Financial Affairs Office)
(27) Encourage corporate venture capital (CVC) activities. Support enterprises in establishing CVCs independently or in collaboration with others to strengthen innovation incubation and synergy across the industrial chain. Provide support to eligible CVCs, including capital contributions from municipal state-owned assets and industrial master funds, as well as fast-track procedures for fund establishment. (Responsible Units: Municipal State-owned Assets Supervision and Administration Commission, Municipal Commission of Economy and Information Technology, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Party Committee Financial Affairs Office)
(28) Support enterprises in expanding and strengthening their operations through mergers and acquisitions (M&A). Establish the Shanghai Biomedical Industry M&A Fund and actively guide qualified biomedical enterprises to initiate and establish M&A funds based on industrial transformation and upgrading needs, supporting enterprises in conducting M&A investments across the upstream and downstream of the industrial chain. (Responsible Units: Municipal SASAC, Municipal Science and Technology Commission, Municipal Party Committee Financial Affairs Office, Municipal Commission of Economy and Information Technology, Municipal Development and Reform Commission)
(29) Expand enterprise financing channels through diverse approaches. Strengthen credit support for enterprises through policy tools such as preferential interest rates and long-term credit interest subsidies for key industries.Leverage the role of the Municipal Policy-Based Financing Guarantee Fund for Small, Medium, and Micro Enterprises to raise the maximum single-batch guarantee limit for small, medium, and micro biopharmaceutical innovation enterprises to 20 million yuan, and to 30 million yuan for medium-sized biopharmaceutical innovation enterprises holding qualifications such as High-Tech, Specialized, Refined, Unique, and New (SRUN), or Science and Technology Little Giant. (Responsible Units: Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Finance Bureau, Municipal Party Committee Financial Affairs Office, Shanghai Financial Regulatory Bureau)
VII. Unlocking the Value of Data Resources
(30) Establish a mechanism for the open sharing of cohort study data. Promote the recording of cohort study data on blockchain platforms. Relying on the Municipal Health Data Platform, provide cohort data analysis services to medical institutions, research institutes, and enterprises and public institutions upon request. Promote the sharing and use of genetic and cellular data among hospitals. Advance the construction of a real-world research information platform for rare diseases and pilot the establishment of an operational mechanism for real-world research on rare disease drugs.(Responsible Units: Municipal Health Commission, Municipal Data Bureau, Municipal Science and Technology Commission, ShenKang Hospital Development Center)
(31) Improve the mechanism for collaborative use of medical and health insurance data resources. Utilizing technologies such as blockchain, privacy-preserving computing, and data spaces, and relying on the “Health Insurance Big Data Innovation Laboratory,” establish a mechanism for data collaboration and utilization among hospitals, health insurance and commercial insurance institutions, and pharmaceutical companies. Strengthen the application of data in scenarios such as innovative drug R&D, clinical diagnosis and treatment, and commercial health insurance products, and accelerate the development of commercial health insurance products.(Responsible Units: Municipal Medical Insurance Bureau, ShenKang Hospital Development Center, Municipal Health Commission, Municipal Data Bureau, Shanghai Financial Regulatory Bureau)
(32) Build high-quality corpora and industry datasets. Focusing on areas such as basic research, new drug R&D, medical services, and insurance product development, create several high-quality AI corpora and industry datasets. Support enterprises and institutions in conducting training of large-scale healthcare models using AI data training facilities. (Responsible Units: Municipal Commission of Economy and Informatization, Municipal Development and Reform Commission, Municipal Data Bureau, Municipal Health Commission, Municipal Medical Insurance Bureau, Shanghai Hospital Development Center)
(33) Promote the secure and compliant flow of industry data. Establish a biopharmaceutical section at the Shanghai Data Exchange to facilitate the lawful and compliant trading of pharmaceutical patents, experimental and testing data, and industry analysis data. Conduct pilot programs in the Lingang New Area of the China (Shanghai) Pilot Free Trade Zone (hereinafter referred to as the “Shanghai Pilot Free Trade Zone”) to support the secure and compliant cross-border flow of data for biopharmaceutical enterprises. (Responsible Units: Municipal Data Bureau, Municipal Cyberspace Administration Office, Lingang New Area Management Committee)
VIII. Promoting the Internationalization of the Industry
(34) Support the investment and development of foreign-invested enterprises in Shanghai. Support foreign-invested enterprises in establishing regional headquarters, foreign-invested R&D centers, open innovation platforms, proof-of-concept centers, and generic technology platforms in Shanghai. Select eligible foreign-invested enterprises within the Shanghai Pilot Free Trade Zone (including the Lingang New Area) to conduct pilot programs for expanding the opening-up of gene diagnosis and therapy technology development and application.Explore the promotion of cross-border segmented production of biopharmaceuticals in Shanghai. (Responsible Units: Municipal Commission of Commerce, Municipal Development and Reform Commission, Municipal Science and Technology Commission, Municipal Health Commission, Municipal Drug Administration, Pudong New Area Government, Lingang New Area Management Committee)
(35) Further improve the convenience of importing and exporting goods. Optimize pilot policies for the import of goods used in R&D, refine the enterprise credit-oriented management model, and expand the scope of the pilot to include reference standards for trace-level testing; exempt eligible reference standards for trace-level testing from the requirement to obtain import permits issued by agricultural and environmental protection authorities. Further expand the scope of items covered by the joint supervision mechanism for special goods entering and leaving the country, and support the import and export of cell therapy products and related special goods.(Responsible Units: Municipal Commission of Commerce, Municipal Commission of Science and Technology, Shanghai Customs, Municipal Drug Administration)
(36) Increase support for the global registration and certification of innovative products.For innovative drugs, modern traditional Chinese medicines, and high-end medical devices developed by local enterprises that are successfully registered with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union (CE), the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, the World Health Organization (WHO), or the drug regulatory authorities of BRICS countries and “Belt and Road” countries, and subsequently sold in those markets, support of up to 30% of R&D expenditures (capped at 10 million yuan) will be provided on a competitive basis in accordance with regulations.Innovative enterprises are encouraged to establish partnerships with multinational corporations. For overseas licensing transactions with an initial payment of 100 million yuan or more (where the parties have no investment or other affiliations), support of up to 50% of the licensing enterprise’s expenditure on third-party professional services—capped at 5 million yuan—will be provided on a merit-based basis in accordance with regulations. (Responsible Units: Municipal Science and Technology Commission, Municipal Commission of Commerce, Municipal Finance Bureau)
(37) Promote international academic and commercial exchanges in the pharmaceutical sector. Deepen scientific and industrial cooperation and exchanges in the biopharmaceutical field among Shanghai, Hong Kong, and Macao. Support the hosting of biopharmaceutical-related conferences, academic exchanges, regulatory alignment activities, and similar events. For enterprises or organizations in our city participating in international events and exhibitions, support of up to 50% of project expenses, with a maximum of 50,000 yuan, will be provided upon approval in accordance with regulations. The cumulative annual support amount for each entity shall not exceed 500,000 yuan. (Responsible Units: Municipal Science and Technology Commission, Municipal Drug Administration, Municipal Finance Bureau)
The scope of support under these guidelines covers enterprises, public institutions, or private non-enterprise units registered within the municipality that are engaged in research and development, production, or professional services in the fields of pharmaceuticals, medical devices, biotechnology, and life science research instruments. Where there is overlap with other similar municipal policies, support shall be provided in accordance with the principle of “selecting the most favorable, applying the highest standard, and avoiding duplication.” Districts are encouraged to provide corresponding supporting measures based on local conditions and to strengthen policy coordination between the municipal and district levels.
These guidelines shall take effect on August 1, 2024, and remain valid until July 31, 2029. During the period from June 1 to July 31, 2024, relevant policy measures involving financial support shall be implemented in accordance with these guidelines.
General Office of the Shanghai Municipal People’s Government
July 15, 2024
