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The construction of the Nanjing Area of Jiangsu Pilot Free Trade Zone
The biomedical industry in Nanjing Jiangbei New Area
Major policy benefits are here!
Yesterday, the Ministry of Commerce and the People’s Government of Jiangsu Province officially issued it
The Open and Innovative Development Plan for the Entire Industrial Chain of Biomedicine in China (Jiangsu) Pilot Free Trade Zone
(Hereinafter referred to as the “Plan”)
The Plan sets out 18 key tasks in 7 aspects, focusing on enhancing the R&D and innovation capabilities of the biopharmaceutical industry, improving the level of product approval and service, building a production and circulation system, perfecting the policies for product procurement and use, and increasing the support and guarantee of elements. It emphasizes the need to leverage the industrial foundation advantages of the Jiangsu Free Trade Zone, carry out full-chain integrated innovation, and strive to achieve this by 2030 The scale of the biopharmaceutical industry in China (Jiangsu) Pilot Free Trade Zone has grown rapidly, the innovation ecosystem has been continuously optimized, the modernization level of the industrial chain has significantly improved, the level of opening up to the outside world has greatly increased, the security guarantee capacity has been constantly enhanced, and breakthroughs have been made in key technologies. Cultivate and form industrial clusters with distinctive advantages in key areas such as macromolecular biopharmaceuticals, cell and gene therapy, and innovative medical devices. The release of the “Plan” has drawn a clear roadmap for the development of the biopharmaceutical industry in the Jiangsu Free Trade Zone.
China (Jiangsu) Pilot Free Trade Zone
Open and Innovative Development Plan for the Entire Industrial Chain of Biomedicine
To fully implement the upgrading strategy of the free trade pilot zone and support the open and innovative development of the entire industrial chain of biomedicine in China (Jiangsu) Pilot Free Trade Zone (hereinafter referred to as Jiangsu Pilot Free Trade Zone), this plan is formulated.
I. General Requirements
Carry out pioneering and integrated exploration, promote the integrated and innovative development of the entire biopharmaceutical industry chain, and build the Jiangsu Free Trade Zone into a biopharmaceutical industry cluster with global influence and a more internationally competitive highland for biopharmaceutical innovation and development.
By 2030, the scale of the biopharmaceutical industry in Jiangsu Free Trade Zone will grow rapidly, the innovation ecosystem will be continuously optimized, the modernization level of the industrial chain will be significantly enhanced, the level of opening up to the outside world will be greatly improved, the security guarantee capacity will be constantly strengthened, and breakthroughs will be made in key technologies. Cultivate and form industrial clusters with distinctive advantages in key areas such as macromolecular biopharmaceuticals, cell and gene therapy, and innovative medical devices.
Second, enhance the R&D and innovation capabilities of biomedicine
(1) Carry out technological innovation in biomedicine and medical devices. Support the layout and implementation of a number of major national science and technology projects in the field of biomedicine, give full play to the role of new scientific research organizations, and focus on breaking through key core technologies of innovative drugs and high-end medical devices. Strengthen the application of big data and artificial intelligence in areas such as drug target screening, drug molecule design, and medical device design and manufacturing. Support enterprises in participating in the formulation of national and industry standards for cell and gene therapy products, artificial intelligence medical devices, biomedical materials, in vitro diagnostic reagents, etc.
(2) Give full play to the leading role of major innovation platforms. Support the construction of the National Biopharmaceutical Technology Innovation Center in the Suzhou Area of Jiangsu Pilot Free Trade Zone, and participate in national science and technology major projects and other national science and technology plans. Support the Jiangsu Free Trade Zone in exploring and improving the management and usage standards for health and medical data, and promote the sharing and application of health big data resources. Support the accelerated construction of the National University Biomedical Technology Transfer and Transformation Sub-Center (Jiangsu) to promote the transformation of biomedical scientific and technological achievements in universities.
(3) Enhance the level of clinical research. Support qualified medical institutions in the Jiangsu Free Trade Zone in establishing national clinical medical research centers. Support qualified public medical institutions in increasing clinical research resources, organize and carry out multi-center and large-sample clinical research, explore the pilot of decentralized clinical trials, and participate in the formulation of international standards and general norms for clinical research. Encourage medical institutions to conduct clinical research in areas such as immune cells, stem cells and gene therapy in accordance with regulations, and support investigator-initiated clinical research. Support the conduct of real-world research. Pilot the establishment of regional biomedical research ethics review committees involving people, and promote mutual recognition of ethics review results among medical institutions.
(4) Promote international collaborative research and development innovation. Optimize the approval procedures for human genetic resource activities involving international cooperation in clinical trials and improve the approval management and service system. For foreign-invested medical device enterprises that meet the conditions, support will be provided for them to use domestic human-derived materials in the product testing stage during the domestic commercial production process in accordance with laws and regulations. Support domestic universities in conducting high-level Sino-foreign cooperative education programs in medical fields with world-renowned medical colleges within the Jiangsu Free Trade Zone.
Iii. Enhance the level of product approval services
(V) Optimize review and approval services. Support drug review service institutions in enhancing communication with national drug review institutions, optimizing technical guidance and services for applicants, and promoting more allocation of review and approval resources towards key innovative drugs and medical devices urgently needed in clinical practice. Support the application for medical device registration certificates and production licenses for artificial intelligence medical service diagnosis software systems in accordance with regulations.
(6) Enhance the capacity for inspection, testing and verification. Strengthen the construction of provincial drug evaluation institutions and inspection and testing institutions, and enhance the batch release capacity of biological products (vaccines). Coordinate the drug inspection and testing resources at both provincial and municipal levels. Reasonably simplify the verification of the quality management system for medical device registration. Those that meet the requirements of laws and regulations can be exempted from on-site inspections.
Iv. Building a production and circulation system for biomedicine
(7) Strengthen and optimize the upstream and downstream industrial chains. Accelerate the construction of advanced manufacturing clusters for biomedicine and high-end medical devices. Accelerate the development of industrial forms such as contract research organizations, production outsourcing services, and customized R&D and production. Under the premise of ensuring product quality and fully assessing risks, explore the implementation of pilot projects for the segmented production of chemical raw materials and biological products. Support enterprises in developing and applying advanced production processes such as continuous manufacturing. Strengthen the research and application of synthetic biology technology, and promote the intelligent and green development of biomanubicin.
(8) Enhance the level of customs clearance facilitation. Support the exemption of affixing Chinese labels to medical device products that enter special customs supervision areas and are not sold or used within the territory of China, and may affix product labels that meet the requirements of the target country according to the final destination of the products.
(IX) Innovate the model of entry and exit supervision. Improve the joint supervision mechanism for the entry of high-risk special items. Support the reform of the supervision model for the entry and exit of laboratory animals. For model animals produced by modifying with human genetic material from abroad that has been approved for import, they shall be supervised in accordance with the export model for laboratory animals when declared for export. Expand the pilot scope of the “white list” system for the import of items used in biomedical research and development.
V. Improve policies for the procurement and use of biopharmaceutical products
(10) Explore the pioneering use of innovative drugs and medical devices. Promote the inclusion of eligible innovative drugs in the national medical insurance drug list, optimize the listing process for innovative drugs, and enhance the listing efficiency.
(11) Enhance the supply level of medical services. Explore the pilot program of purchasing services for artificial intelligence medical image-assisted diagnosis technology, and expand the scope of application of existing medical service price items such as outpatient consultation to situations where auxiliary diagnosis technology services are introduced.
Six. Increase support and guarantee for elements
(12) Improve policies for talent evaluation and incentives. Allow the Jiangsu Free Trade Zone to formulate evaluation standards for urgently needed and scarce talents based on the development needs of the biopharmaceutical industry and pilot a market-oriented evaluation mechanism. Implement the comparative recognition of international professional qualifications in biomedicine with corresponding professional titles, and support the establishment of a senior professional title review committee for biomedicine.
(13) Promote the facilitation of work permits and entry and exit. Support overseas physicians to practice medicine or provide related services for a short period in medical institutions within the Jiangsu Free Trade Zone in accordance with regulations. Research and promote the working model of “one-stop acceptance and parallel approval” for work permits and work-related residence permits for foreigners coming to China.
(14) Strengthen financial support for industrial development. Support qualified innovative biopharmaceutical enterprises to raise funds through listing on the Growth Enterprise Market, the STAR Market, the Beijing Stock Exchange, listing on the New Third Board, and issuing corporate credit bonds. Encourage and guide industrial investment funds, venture capital funds, etc. to initiate the establishment of biomedicine industry investment sub-funds. Support qualified biomedicine industrial park projects in issuing infrastructure real estate investment trusts (REITs) and real estate trust asset-backed notes. Establish and improve a market-oriented risk insurance compensation mechanism for research and development breakthroughs in the field of biomedicine.
(15) Strengthen the protection and application of intellectual property rights. Accelerate the construction of an intellectual property operation center for the biopharmaceutical industry and cultivate intellectual property demonstration enterprises. Actively apply the early resolution mechanism for drug patent disputes. Explore and promote the securitization of intellectual property rights in the biomedicine industry.
(16) Support cross-border data flow. Support the research and formulation of a negative list for data export in the field of biomedicine. Support the establishment of a public service platform for the security of data export.
Vii. Firmly hold the bottom line of risks for safe development
(17) Strengthen risk prevention and control in key areas and key products. Strengthen the supervision of work safety in the biopharmaceutical industry and intensify the source control of major safety risks. Strengthen the safety management of biotechnological research, development and application activities such as the development and application of cell and gene diagnosis and treatment technologies, intensify the supervision and management of biosafety in key laboratories and international cooperation on human genetic resources, and improve the risk assessment, early warning and emergency response mechanisms. Urge enterprises to strengthen the full-process quality control of key products such as cell therapy products, intensify the inspection and verification of high-risk varieties and newly launched products, and promote digital and intelligent supervision. Strengthen the capacity building for biosecurity risk prevention and control in R&D, production, import and export and other links, and support key enterprises in establishing biosecurity management systems.
(18) Strengthen regulatory capacity building by benchmarking against international advanced levels. Support benchmarking against international regulatory coordination mechanisms such as the International Coordination Organization for the Regulation of Medicines for Human Use and the International Drug Inspection Cooperation Program, and take the lead in enhancing the international regulatory capacity for drugs and medical devices. Strengthen the construction of the regulatory team and capacity for drugs and medical devices. Strengthen exchanges and cooperation on drug supervision with major trading partners.
Under the centralized and unified leadership of the Central Committee of the Communist Party of China, the People’s Government of Jiangsu Province should earnestly fulfill its primary responsibility, formulate special plans, accelerate the implementation of various tasks, strengthen collaborative supervision, and intensify risk prevention and control in key areas. Relevant departments of The State Council should, in accordance with their respective duties, actively offer support, enhance guidance and services, and form a working synergy. The Ministry of Commerce should play a good role in overall coordination, fully mobilize the enthusiasm of localities and departments, and ensure the implementation of key reform pilot tasks. Where it is necessary to adjust the current laws or administrative regulations, the legal procedures shall be followed. Major matters should be reported and requested for instructions in a timely manner in accordance with the procedures.
(This article has been abridged.
