Jiangsu Pilot Free Trade Zone Nanjing Area Construction Nanjing Jiangbei New Area Biomedical Industry
A major policy boon!
yesterday
The Ministry of Commerce and the People's Government of Jiangsu Province officially issued the
Program for the Open and Innovative Development of the Entire Biomedical Industry Chain in the China (Jiangsu) Pilot Free Trade Zone
(hereinafter referred to as the Program)
Focusing on the biomedical industry to enhance R&D and innovation capabilities, improve the level of product approval services, build a production and circulation system, improve the policy of product procurement and use, and increase the support and protection of factors and other links, the "Program" puts forward 18 key tasks in 7 areas, emphasizing the need to play the advantages of the industrial base of Jiangsu FTZ, and carry out integrated innovation of the whole chain, and strive to achieve the goal of 2030, the China (Jiangsu) Pilot Free Trade Zone By 2030, China (Jiangsu) Pilot Free Trade Zone will see rapid growth in the scale of biomedical industry, continuous optimization of the innovation ecology, significant improvement in the modernization of the industrial chain, substantial increase in the level of opening up to the outside world, continuous enhancement of safety and security capabilities, breakthroughs in key technologies, and the cultivation and formation of industrial clusters with distinctive advantages in the key areas of large molecule biopharmaceuticals, cellular and gene therapies, and innovative medical devices. The introduction of the Program has drawn a clear roadmap for the development of biomedical industry in Jiangsu Pilot Free Trade Zone.
With Xiao Bei.
Take a look at the original Program ↓↓
Ministry of Commerce Jiangsu Provincial People's Government on the issuance of
Notice of the Program for the Open and Innovative Development of the Entire Biomedical Industry Chain in the China (Jiangsu) Pilot Free Trade Zone
(UNCTAD [2025] 162)
Jiangsu Provincial People's Government, National Development and Reform Commission, Ministry of Education, Ministry of Science and Technology, Ministry of Industry and Information Technology, Ministry of Finance, Ministry of Human Resources and Social Security, Ministry of Ecology and Environment, Ministry of Commerce, National Health and Wellness Commission, Ministry of Emergency Management, People's Bank of China, General Administration of Customs, General Administration of Market Supervision, General Administration of Financial Supervision, China Securities Regulatory Commission, State Intellectual Property Office, National Health Insurance Bureau, State Internet Information Office, National Immigration Bureau, China Civil Aviation Administration (CAA), and State Drug Administration (SDA):
China (Jiangsu) Pilot Free Trade Zone Biomedical Industry Chain Open and Innovative Development Program" has been agreed by the State Council, is issued to you, please in accordance with the "State Council on the of the Approval of the State Council" (State letter [2025] No. 80) relevant requirements, and seriously do a good job in the implementation of the implementation.
Ministry of Commerce Jiangsu Provincial People's Government
August 25, 2025
China (Jiangsu) Pilot Free Trade Zone
Open Innovation Development Program for the Entire Biomedical Industry Chain
This program is formulated to fully implement the strategy of upgrading the Pilot Free Trade Zone and support the open and innovative development of the entire biomedical industry chain in China (Jiangsu) Pilot Free Trade Zone (hereinafter referred to as Jiangsu Pilot Free Trade Zone).
I. General requirements
Guided by Xi Jinping's thought of socialism with Chinese characteristics in the new era, deeply implementing the spirit of the 20th CPC National Congress and the 2nd and 3rd Plenary Sessions of the 20th CPC Central Committee, adhering to the overall keynote of seeking progress amidst stability, implementing the new development concept completely and accurately, accelerating the construction of a new development pattern, promoting high-quality development in a solid way, better coordinating the development and security, taking the high level of openness as the lead, taking the system innovation as the core, carrying out the pioneering and integrative explorations In order to promote the integrated and innovative development of the whole biomedical industry chain, Jiangsu Pilot Free Trade Zone will become a biomedical industry agglomeration with world influence and a biomedical innovation and development highland with more international competitiveness.
Strive to 2030, Jiangsu Pilot Free Trade Zone biomedical industry scale rapid growth, innovation ecology continues to optimize, the level of industry chain modernization significantly improved, the level of opening up significantly, security and protection capabilities continue to strengthen, key technology breakthroughs, in large molecules of biopharmaceuticals, cellular and gene therapy, innovative medical devices, and other key areas to cultivate the formation of industrial clusters with characteristics and advantages.
II. Enhancing biomedical R&D and innovation capacity
(i) Development of 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, play the role of a new type of scientific research organizations, and focus on breakthroughs in key core technologies of innovative drugs and high-end medical devices. Strengthen the application of big data and artificial intelligence in drug target screening, drug molecular design, medical device design and manufacturing. Support enterprises to participate in the development of national and industrial standards for cell and gene therapy products, artificial intelligence medical devices, biomedical materials and in vitro diagnostic reagents.
(ii) Playing a leading role in major innovation platforms.Support Jiangsu Pilot Free Trade Zone Suzhou Area to build a national biopharmaceutical technology innovation center and participate in national science and technology projects such as national science and technology major projects. Support Jiangsu Pilot Free Trade Zone to explore and improve the standards for the management and use of healthcare data and promote the sharing and application of health big data resources. Support the acceleration of the construction of the national university biomedical technology transfer and transformation sub-center (Jiangsu), and promote the transformation of university biomedical scientific and technological achievements.
(iii) Upgrading clinical research.Supporting qualified medical institutions in Jiangsu Pilot Free Trade Zone to build national clinical medical research centers. Support qualified public medical institutions to increase 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 development of international standards and general specifications for clinical research. Encourage medical institutions to carry out clinical research in the fields of immune cells, stem cells and gene therapy in accordance with regulations, and support the conduct of investigator-initiated clinical research. Support the conduct of real-world research. Pilot the establishment of regional biomedical research ethics review committees involving human beings, and promote mutual recognition of the results of ethics review by medical institutions.
(iv) Promoting international collaborative research and development innovation.Optimize the approval procedures for human genetic resources activities involving international cooperation in clinical trials, and improve the approval management service system. For qualified foreign-invested medical device enterprises, support the use of local human-derived materials in product testing during commercial production in the territory in accordance with laws and regulations. Supporting domestic universities and world-renowned medical schools to carry out high-level Chinese-foreign cooperative education in medicine in the Jiangsu Pilot Free Trade Zone.
III. Upgrading product approval services
(v) Optimizing review and approval services.Support the drug evaluation service organizations to strengthen exchanges with national drug evaluation agencies, optimize technical guidance and services to applicants, and promote the evaluation and approval of resources to tilt more towards key innovative drugs and medical devices in urgent clinical need. Supporting the declaration of medical device registration certificates and production licenses for artificial intelligence medical service diagnostic software systems as required.
(vi) Upgrading inspection, testing and verification capabilities.Strengthening the construction of provincial drug evaluation organizations and inspection and testing organizations, and upgrading the capacity for the wholesale and issuance of biological products (vaccines). Coordinate drug inspection and testing resources at the provincial and municipal levels. Reasonably simplify the verification of quality management system for medical device registration, and exempt from on-site inspection for those meeting the requirements of laws and regulations.
IV. Building a biomedical production and distribution system
(vii) Strengthening and optimizing upstream and downstream industrial chains.Accelerate the construction of advanced manufacturing clusters for biopharmaceuticals and high-end medical devices. Accelerate the development of contract research organizations, production outsourcing services, customized R&D and production and other industrial forms. On the premise of guaranteeing product quality and fully assessing risks, explore pilot projects for the segmented production of chemical APIs and biological products. Support enterprises to develop and apply advanced production processes such as continuous manufacturing. Strengthen the R&D and application of synthetic biotechnology, and promote the intelligent and green development of biomanufacturing.
(viii) Enhancement of customs clearance facilitation.Support for the entry of special customs supervision areas and not in the Chinese territory of the sale and use of medical equipment products are exempted from the affixing of Chinese labels, and according to the final destination of the product affixed with product labels in line with the requirements of the target country.
(ix) Innovative modes of entry-exit supervision.Improving the joint supervision mechanism for the entry of high-risk special items. Supporting the reform of the regulatory model for inbound and outbound experimental animals, model animals produced by using human genetic material imported from overseas with authorization for modification are regulated in accordance with the export model for experimental animals when declared for export. Expanding the scope of the pilot "white list" system for the import of articles for biomedical research and development.
V. Improvement of policies on the procurement and use of biomedical products
(x) Explore the pioneering use of innovative medicines and devices.Promote the inclusion of eligible innovative drugs in the national health insurance drug catalog, optimize the process of listing innovative drugs and improve the efficiency of listing.
(xi) Upgrading the level of medical service provision.Explore the development of artificial intelligence medical imaging assisted diagnostic technology to purchase services on a pilot basis, and expand the scope of application of existing medical service price items, such as outpatient consultation and examination, to situations where assisted diagnostic technology services are introduced.
VI. Increasing factor support and security
(xii) Improve talent evaluation and incentive policies.Allow Jiangsu Pilot Free Trade Zone to formulate evaluation standards for urgently needed and scarce talents according to the development needs of the biomedical industry, and try out the market-oriented evaluation mechanism. The implementation of international professional qualifications in biomedicine and the corresponding titles are recognized, and the formation of a senior title review committee in biomedicine is supported.
(xiii) Promoting work permits and immigration facilitation.Supporting overseas physicians to practice medicine or engage in related services in medical institutions in Jiangsu Pilot Free Trade Zone for a short period of time in accordance with the regulations. Studying and promoting the working mode of "one-pass acceptance and parallel examination and approval" for foreigners' work permits and work-type residence permits to come to China.
(xiv) Strengthening financial support for industrial development.Support qualified biomedical innovative enterprises to raise funds through listing on the GEM, KIC and NSE, listing on the New Third Board, and issuing corporate credit-type bonds. Encourage and guide industrial investment funds and venture capital funds to initiate and set up investment sub-funds for the biomedical industry. Support qualified biomedical industrial park projects to issue real estate investment trusts (REITs) and real estate trust asset-backed notes in the infrastructure sector. To establish and improve the market-oriented risk insurance compensation mechanism for R&D and research in the field of biomedicine.
(xv) Strengthening the protection and utilization of intellectual property rights.Accelerate the construction of an intellectual property operation center for the biomedical industry and cultivate intellectual property demonstration enterprises. Actively utilize the mechanism for early resolution of pharmaceutical patent disputes. Explore the promotion of intellectual property securitization in the biomedical industry.
(xvi) Supporting cross-border flow of data.Supporting the study and formulation of a negative list of data exit in the field of biomedicine. Supporting the establishment of a public service platform for data exit security.
VII. Securing the safety and development risk floor
(xvii) Strengthening risk prevention and control of key products in key areas.Strengthening the supervision of production safety in the biomedical industry, and enhancing the source control of major safety risks. It has strengthened the safety management of biotechnology research, development and application activities, such as the development and application of cellular and gene diagnostic technologies, reinforced the supervision and management of the biological safety of key laboratories and international cooperation in human genetic resources, and improved the mechanisms for risk assessment, early warning and emergency response. It has urged enterprises to strengthen whole-process quality control of cell therapy products and other key products, strengthened inspection and verification of high-risk varieties and newly-listed products, and pushed forward digitalized intelligent supervision. It has strengthened the construction of biosafety risk prevention and control capacity in R&D, production, import and export, and supported key enterprises in establishing biosafety management systems.
(xviii) Strengthening regulatory capacity building by benchmarking against international advanced levels.Supporting the benchmarking of international regulatory coordination mechanisms, such as the International Organization for the Coordination of the Regulation of Pharmaceuticals for Human Use and the International Drug Inspection Cooperation Programme, and taking the lead in enhancing the international regulatory capacity of pharmaceuticals and medical devices. Strengthen the regulatory team and capacity building for drugs and medical devices. Strengthen exchanges and cooperation with major trading partners in drug regulation.
Under the centralized and unified leadership of the CPC Central Committee, the People's Government of Jiangsu Province should effectively carry out the main responsibility, formulate special programs, accelerate the implementation of various tasks, strengthen collaborative supervision, and strengthen the prevention and control of risks in key areas. The relevant departments of the State Council should actively give support in accordance with the division of responsibilities, strengthen guidance services, and form a synergy of work. The Ministry of Commerce should play a good role in coordinating and fully mobilizing local and departmental enthusiasm, and grasp the implementation of key reform pilot tasks. Where adjustment of existing laws or administrative regulations is required, it will be handled in accordance with legal procedures. Major matters will be reported in a timely manner and in accordance with procedures.
(This article has been abridged)
