Action Plan of Shanghai Municipality for Promoting the International Competitiveness of Biopharmaceutical Enterprises (2024-2027)

This Action Plan is formulated with a view to further promoting the international competitiveness of biopharmaceutical enterprises in this Municipality, and advancing the overseas launch of innovative pharmaceuticals and medical devices produced in Shanghai so as to contribute Shanghai's part to the addressing of global clinical needs.

I. General Requirements

Targeting the overseas market, efforts shall be made to strengthen the research and development (R&D) of innovative products, and accelerate the expansion of Shanghai-produced innovative pharmaceuticals and medical devices into the international market through methods including self-built or co-built international marketing networks, overseas license-out, international organization procurement, and provision of aid and construction assistance. By 2027, the internationalization capabilities of the biopharmaceutical enterprises in this Municipality will have been further enhanced, with the export value of pharmaceuticals and medical devices exceeding 50 billion yuan, and two to three enterprises with annual overseas market sales exceeding 10 billion yuan.

II. Key Tasks

1. Strengthening the R&D of Innovative Pharmaceuticals and Medical Devices with International Competitiveness

(1) Providing continuous support for innovation and R&D. Biopharmaceutical enterprises are supported to strengthen their forward-looking strategic layout in the international cutting-edge fields and new arenas such as synthetic biology, cell and gene therapy, nucleic acid drugs, brain-machine interfaces, and AI-plus pharma, in order to enhance their innovation capabilities, including early-stage R&D. These enterprises will, in alignment with international standards and norms, develop high-quality and innovative pharmaceuticals and medical devices targeting the global market. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Health, and Shanghai Hospital Development Center)

(2) Promoting enterprises to build a global R&D system. Enterprises are supported to establish their R&D centers and other branches overseas, form overseas R&D teams, and to build a global innovation network through methods including in-depth cooperation with overseas high-level research institutes and leading enterprises. (Responsible units: the Municipal Commission of Science and Technology, and the Municipal Commission of Commerce)

(3) Enhancing the internationalization capability of clinical tests. Efforts shall be made to promote the establishment of partnerships with clinical testing institutions in the sister cities of and cities with friendly exchanges with this Municipality, to jointly conduct international multi-center clinical tests, and advance mutual data recognition, among other cooperative work. Support shall be provided to conduct overseas high-level clinical tests of Shanghai-developed innovative pharmaceuticals and medical devices. Medical institutions in this Municipality are supported in their undertaking of International Multi-center Clinical Tests (IMCT) initiated by registrants within this Municipality. Insurance institutions are encouraged to develop liability insurance for overseas clinical tests and high-end medical equipment, and support will be provided to insured enterprises. (Responsible units: the Municipal Commission of Science and Technology, Foreign Affairs Office of the Municipal People's Government, the Municipal Commission of Health, Financial Commission Office of the CPC Municipal Committee, the Municipal Bureau of Finance, the Municipal Medical Products Administration, Shanghai Municipal Financial Regulatory Bureau, and Shanghai Hospital Development Center)

(4) Increasing support for the overseas launch of innovative pharmaceuticals and medical devices. Innovative pharmaceuticals and medical devices which are developed by enterprises in this Municipality are supported to apply for registration, and launch into the market, with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), European Conformity (CE), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), the World Health Organization (WHO), and the medical products administrations of BRICS and Belt and Road Initiative countries. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Medical Products Administration, and the Municipal Bureau of Finance)

2. Accelerating the Cultivation of Local Multinational Enterprises

(5) Promoting the internationalization of enterprises. Stronger policy support is provided for enterprises in terms of their innovation and R&D, clinical tests and customs clearance, foreign exchange, and other related aspects. Enterprises are promoted to formulate and implement strategies on internationalized development and plans for cross-border operation and development, in terms of brands, capital, markets, talents and technology. Efforts shall be made to accelerate improvements in management structures and systems for cross-border operation, and comprehensively enhance the internationalization capabilities of enterprises in their overseas R&D, marketing, etc. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Commerce, and the Municipal State-owned Assets Supervision and Administration Commission)

(6) Encouraging enterprises to engage in overseas investment and mergers & acquisitions (M&A). Enterprises are supported in their undertaking of corporate venture capital (CVC) investments either independently or in collaboration with other enterprises. For the purpose of overseas investment or M&A, state-owned capital funds, industrial fund of funds (FOFs), and other funds are promoted to explore co-investment with enterprises in establishing CVC and other funds. (Responsible units: the Municipal Development and Reform Commission, the Municipal State-owned Assets Supervision and Administration Commission, the Municipal Commission of Science and Technology, and Financial Commission Office of the CPC Municipal Committee)

3. Promoting the Internationalization of Innovative small and Medium-sized Enterprises (SMEs)

(7) Supporting the establishment of a league for enterprise internationalization. Resources for driving innovation in biopharmaceutical R&D, clinical tests, registration, and selling shall be pooled together to leverage the leading roles of multinational enterprises and leading enterprises, as well as the catalytic effect of these enterprise incubators. Enterprises in this Municipality are supported to collaborate with related industry chain enterprises in connecting with overseas institutions, in order to co-build international marketing networks, and jointly tap into the international market. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Commerce, and the Municipal State-owned Assets Supervision and Administration Commission)

(8) Organizing and conducting international exchanges and cooperation. Enterprises in this Municipality are organized and supported to engage in international exchanges and exhibitions. Relying on hallmark events such as the Shanghai International Biopharmaceutical Industry Week, these enterprises are supported to launch their new achievements, new technologies and new products in the overseas market, thereby enhancing the international influence of the enterprises in this Municipality. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Council for the Promotion of International Trade, and the Municipal Bureau of Finance)

4. Promoting the Entry of Innovative Pharmaceuticals and Medical Devices into the International Market

(9) Encouraging overseas licensing-out. Exchange platforms shall be established to foster connection and cooperation between multinational enterprises and innovation-based enterprises. Local enterprises are supported to license out the rights of Shanghai-produced innovative pharmaceuticals and medical devices to multinational enterprises, for the purpose of leveraging the latter's resources including R&D capabilities and marketing networks to conduct clinical tests, application and registration, and selling to hospitals, and to accelerate the launch in the overseas market of these innovative pharmaceuticals and medical devices. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Commerce, and the Municipal Bureau of Finance)

(10) Supporting participation in international bulk procurement. Enterprises are encouraged to actively participate in international bulk procurement organized by international organizations such as the World Health Organization and the United Nations Children's Fund, non-governmental organizations, and overseas governmental agencies. Support is provided to enterprises who have passed the WHO product prequalification. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Health, the Municipal Medical Products Administration, and the Municipal Bureau of Finance)

(11) Supporting participation in international aid and construction assistance. Support shall be provided to incorporate innovative medical devices and equipment in this Municipality into the Recommended Industry-specific Catalog of Major Equipment, Materials and Products for Foreign Aid Complete-Equipment Projects. Enterprises of innovative pharmaceuticals and medical devices in this Municipality are encouraged to actively participate in international construction assistance and aid. (Responsible units: the Municipal Commission of Commerce, the Municipal Commission of Health, and Foreign Affairs Office of the Municipal People’s Government)

5. Optimizing the Environment for Enterprises' Internationalized Development

(12) Strengthening overall coordination. The Municipal Commission of Science and Technology shall strengthen coordination and collaboration with relevant departments and units, to play an active role in addressing difficulties and issues encountered by enterprises in the process of internationalization. (Responsible units: the Municipal Commission of Science and Technology, Financial Commission Office of the CPC Municipal Committee, the Municipal Talent Bureau, the Municipal Development and Reform Commission, the Municipal Commission of Commerce, the Municipal Commission of Education, the Municipal Commission of Health, the Municipal Administration for Market Regulation, Foreign Affairs Office of the Municipal People's Government, the Municipal Healthcare Security Administration, the Municipal Intellectual Property Administration, the Municipal Medical Products Administration, and Shanghai Customs District of the PRC)

(13) Enhancing capabilities for professional service. Efforts shall be made to strengthen the development of public service platforms concerning clinical tests and laboratory animals, in order to support domestic and international enterprises in their early-stage R&D and clinical tests in Shanghai. Efforts shall be made to accelerate the building of functional platforms for internationalized development, including the Shanghai "Belt and Road" Integrated Service Center, the Consultation Station for Serving the RCEP Enterprises, and the Hongqiao Service Center for Overseas Development. A group of market-oriented institutions that provide professional service are cultivated, including internationalized Contract Research Organizations (CROs), and inspection and testing agencies. Relevant institutions are supported in their in-depth development in destination countries and regions, so as to provide services for the overseas expansion of enterprises. Efforts shall be made to accelerate the building of quality inspection centers for innovative biopharmaceutical products and medical robotics in Shanghai, and enhance the inspection and testing capabilities of Shanghai Testing & Inspection Institute for Food and Drug and Shanghai Testing & Inspection Institute for Medical Devices. Third-party inspection and testing institutions are supported to obtain recognition qualifications from mainstream international regulatory agencies, and meanwhile, internationally renowned and authoritative inspection, testing, and certification institutions are encouraged to be brought in. Institutional openness in key and professional service sectors will be advanced, and professional service institutions in law, patent, taxation, and other fields are encouraged to establish their global presence through multiple channels. Exchange and communication between law firms, arbitral institutions, mediation organizations on the one hand, and biopharmaceutical enterprises on the other will be facilitated in order to jointly establish Shanghai as a preferred place for resolving international commercial disputes related to innovative pharmaceuticals and medical devices. Warehousing, transportation, maintenance, and other related service providers are supported to expand their business overseas. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Commerce, the Municipal Commission of Health, the Municipal State-owned Assets Supervision and Administration Commission, the Municipal Bureau of Justice, the Municipal Intellectual Property Administration, the Municipal Administration for Market Regulation, the Municipal Bureau of Finance, the Municipal Tax Service, the Municipal Council for the Promotion of International Trade, and Shanghai Hospital Development Center)

(14) Optimizing convenient clearance measures related to importation and exportation. Efforts shall be made to improve convenient clearance measures for stages such as R&D, production, product launch, and selling of innovative pharmaceuticals and medical devices, and optimize customs clearance processes including document review and on-site inspection. With further implementation of a joint supervision mechanism for the entry and exit of special items, support is provided for the entry and exit of cell-therapy products and other related special items. Bonded repairs for high-end medical devices shall be carried out on a pilot basis. (Responsible units: Shanghai Customs District of the PRC, the Municipal Commission of Commerce, the Municipal Commission of Science and Technology, the Municipal Commission of Health, the Municipal Medical Products Administration, and the Municipal Bureau of Ecology and Environment)

(15) Strengthening financial product innovation and service. Financial institutions of various types are supported to develop new products for biopharmaceutical enterprises such as special-purpose loans for cross-border M&A and overseas business expansion, and exchange rate hedging in emerging markets for biopharmaceutical enterprises, and are supported to provide services such as export buyer's credit, overseas financial leasing, local currency settlement in emerging markets, and export credit insurance. Banks are supported to include more eligible enterprises in their quality enterprise lists, providing such enterprises with efficient and facilitated cross-border financial services. (Responsible units: the Financial Commission Office of the CPC Municipal Committee, Shanghai Municipal Financial Regulatory Bureau, the Municipal Commission of Science and Technology, the Municipal Bureau of Finance, Shanghai Branch of the State Administration of Foreign Exchange, and Shanghai Head Office of the People's Bank of China)

(16) Strengthening the bringing-in and cultivation of professionals with expertise. Efforts shall be made to accelerate the bringing-in and cultivation of professionals with international business experiences in areas such as clinical tests, application and registration, and testing & inspection. Increased support will be provided for international talents in the biopharmaceutical field through measures such as special talent rewards for key industrial sectors. (Responsible units: the Municipal Talent Bureau, the Municipal Commission of Education, the Municipal Commission of Science and Technology, and the Municipal Commission of Economy and Informatization)

(17) Enhancing the capabilities of international collaboration and regulation. Efforts shall be made to collaborate with the National Medical Products Administration (NMPA) to participate in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), accelerate integration into the global mutual recognition and cooperation system for regulatory standards, and enhance the international recognition of domestic clinical research data and GMP (Good Manufacturing Practice) compliance inspection conclusions. Efforts shall be made to cultivate international inspectors for pharmaceuticals and medical devices, and to continuously improve their regulatory capabilities and professionalism. (Responsible units: the Municipal Medical Products Administration, Yangtze River Delta Center for Drug Evaluation and Inspection of NMPA, and Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA)

(18) Strengthening risk prevention. Cross-departmental cooperation shall be enhanced, with a focus on fields such as law, patent, taxation, foreign exchange, data, and industrial and supply chains. Enterprises are guided to draft and improve risk prevention plans in order to enhance their capabilities to manage overseas risks. (Responsible units: Foreign Affairs Office of the Municipal People's Government, the Municipal Commission of Commerce, Office of the Cyberspace Affairs Commission of the CPC Municipal Committee, the Municipal Bureau of Justice, the Municipal Intellectual Property Administration, Shanghai Branch of the State Administration of Foreign Exchange, the Municipal Commission of Science and Technology, the Municipal Development and Reform Commission, the Municipal State-owned Assets Supervision and Administration Commission, the Municipal Administration for Market Regulation, the Municipal Bureau of Public Security, the Municipal Council for the Promotion of International Trade, and all district people's governments)