Article 1 In order to give full play to the advantages of biomedical science and technology and industrial ecology with Zhangjiang as the leader, to implement the requirements of the national strategy, to promote the high-quality development of the biomedical industry in Pudong New Area, to promote the formation of the world-class biomedical industry clusters in Pudong New Area, and to better satisfy the needs of the masses of the people for a healthy life, these provisions are formulated in accordance with the principles of the relevant laws and administrative regulations and the actual situation of Pudong New Area. The basic principles of relevant laws and administrative regulations, combined with the actual situation in Pudong New Area, the formulation of these provisions.

Article 2 The provisions of this regulation shall apply to the research and development of biopharmaceuticals, production, operation, use, and related promotion and protection of activities in the administrative area of Pudong New Area.

Article 3 The city adheres to the principles of system leadership, reform and innovation, people-oriented, openness and cooperation, risk prevention, science and norms, and promotes the high-quality development of the biomedical industry in Pudong New Area.

Article 4 The Municipal People's Government shall strengthen the leadership of the development of the biomedical industry in Pudong New Area, establish and improve the mechanism for promoting the development of the biomedical industry, deepen the collaboration with the relevant departments of the State, and coordinate the development of the biomedical industry in the Pudong New Area in the development of major issues.

The People's Government of Pudong New Area shall establish a mechanism for promoting the development of the biomedical industry in Pudong New Area, strengthen the development of the biomedical industry led by Zhangjiang, and promote the innovative development of biomedical industry in Pudong New Area.

The relevant town people's governments, street offices, and park management organizations in Pudong New Area should do a good job in promoting and protecting the development of the biomedical industry within their scope of responsibilities.

Article 5 The municipal economy and information technology department is responsible for coordinating the development of the city's biomedical industry, and coordinating the promotion of Pudong New Area biomedical industry innovation highland construction.

Municipal and Pudong New Area development and reform, science and technology, business, health, drug supervision, medical security, finance, planning and resources, ecological environment, human resources and social security, local financial supervision, greening and cityscape departments, as well as the customs and other units in accordance with their respective responsibilities and the provisions of this regulation, is responsible for the biomedical industry of the Pudong New Area Promotion work.

Article 6 The People's Government of Pudong New Area to establish the Pudong New Area Biomedical Industry Development Expert Committee. The expert committee is responsible for the development of biomedical industry in Pudong New Area, project planning, key layout and other matters to carry out scientific evidence, put forward opinions and recommendations. The expert committee's opinions and recommendations as an important reference for decision-making on the development of the biomedical industry.

Article VII The people's government of the city, Pudong New Area shall promote the development of human cells and gene industry into the development of biomedical industry coordination and promotion mechanism, in the premise of controllable risk, to support the qualified diversified investment subject to carry out the research and development of human cells, gene technology and promote the industrialization process.

Municipal and Pudong New Area science and technology, health and health departments should strengthen the Pudong New Area biomedical enterprises to carry out human cells, gene technology development and application of supervision, strengthen the risk control.

Article 8 For the relevant state departments to authorize the scope of the biomedical enterprises in Pudong New Area, to explore its cross-border research and development of goods required (including materials, supplies, reagents, etc.) to implement bonded supervision.

In accordance with the requirements of information sharing and risk control by the regulatory authorities, the relevant key biomedical enterprises in Pudong New Area can carry out bonded maintenance business for high value-added, high-tech and environmentally friendly medical devices according to the state regulations; the relevant enterprises in the specific areas of Pudong New Area can carry out export maintenance of high-end medical equipment according to the state regulations. High-end medical equipment to return to the country for repair. The repaired medical devices should be reshipped to overseas according to their sources.

Article IX Pudong New Area has the conditions for commercial-scale production of drugs and in line with the quality management standard for drug production of biopharmaceutical enterprises, drug clinical trials stage of the application for drug production license, in the commitment to clinical samples of production conditions and the application for marketing authorization phase of the production conditions are consistent with the case, the city drug regulatory department can issue the "Drugs", the "Drugs", "Drugs", "Drugs", "Drugs", "Drugs" and "Drugs". Municipal drug regulatory authorities can issue a "drug production license.

Article 10 Pudong New Area, the holder of a marketing license for drugs can produce their own drugs, but also commissioned by the law of the production of pharmaceutical enterprises. Approved by the national drug regulatory authorities, Pudong New Area drug listing license holder can be entrusted to the city within the scope of more than one qualified drug production enterprises. The city drug regulatory department should do a good job of guidance, services, and with the state drug regulatory department to carry out the relevant review work.

Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical chemicals shall not be entrusted with the production of drugs, except as otherwise provided by the State Drug Administration.

Article 11 There are no domestic products of the same variety of in vitro diagnostic reagents on the market, the Pudong New Area qualified medical institutions according to clinical needs, you can develop their own, under the guidance of licensed physicians in the use of the unit. The specific measures by the city drug regulatory department in conjunction with the city health department to develop.

Article 12 The municipal people's government within the scope of national authorization, may approve the Pudong New Area eligible medical institutions to import a small amount of clinically necessary drugs and medical devices. Imported drugs and medical devices should be used in designated medical institutions for specific medical purposes.

Eligible biomedical enterprises are encouraged to conduct clinical real-world data application research on small quantities of imported medicines and medical devices that are urgently needed for clinical purposes, and to explore the use of clinical real-world data for the registration of medicines and medical devices, so as to accelerate the launch of medicines and medical devices.

Article 13 The city in accordance with the relevant state authorization, in the relevant areas of the pilot to promote eligible Pudong New Area drugs and medical devices trading platform to carry out cross-border e-commerce retail import of some drugs and medical devices business.

The city's drug regulatory authorities should combine the actual needs of the development of the biomedical industry in the Pudong New Area, under the premise of ensuring that the quality of the operation of the safety and security of the premise, to optimize the implementation of the wholesale drug license to meet the needs of modern logistics of drugs.

Article 14 The city according to the Pudong New Area biomedical enterprises in the research and development needs, the planning layout and construction of imported non-human primates and other experimental animal isolation and quarantine field.

Pudong New Area to encourage social capital investment in accordance with the law to carry out research and development of biopharmaceuticals related to non-human primates and other experimental animals and related products such as preservation of breeding, breeding, production, supply and other activities, to ensure that the use of biopharmaceutical research and development needs. The need to produce and use non-human primates and other experimental animals, should be approved by the Pudong New Area science and technology and economic departments and wildlife protection authorities, according to the law to obtain the production of experimental animals, the use of licenses.

The Pudong New Area Health Department, in conjunction with the Department of Agriculture and Rural Affairs, is responsible for the filing of new construction, alteration, or expansion of animal biosafety level 2 laboratories in Pudong New Area related to human health.

Article 15 The city to establish micro-organisms, human tissue, biological products, blood and its products and other biomedical special items such as entry and exit joint regulatory mechanism. Pudong New Area People's Government shall, in conjunction with the relevant departments of the biomedical enterprises and their entry and exit of special items to carry out a comprehensive assessment of the assessment of the enterprise and the items issued by the corresponding biosafety control capacity of the certificate. Shanghai Customs, with the proof and other materials submitted by the enterprise, to simplify customs clearance procedures.

The city established a pilot joint promotion mechanism for the import of biomedical R&D articles. The People's Government of Pudong New Area, together with the relevant departments, shall recognize the enterprises and articles imported for R&D purposes. The recognized enterprises and articles do not need to submit the imported drug customs declaration when going through the customs clearance procedures.

The Pudong New Area has established a service platform for the management of imported micro-consumables for R&D. The platform provides support in terms of import licenses, customs clearance facilitation, and permission for distribution.

Article 16 The city in the Pudong New Area to set up human genetic resources management services, human genetic resources to carry out counseling, services, training, research and so on, to assist the national and municipal human genetic resources management institutions to carry out human genetic resources in the aftermath of the supervision of the work.

Article 17 The Pudong New Area administrative area of the drug inspection and testing organizations designated by the state drug regulatory authorities, can carry out the registration of innovative drugs test work. Municipal drug regulatory departments, the Pudong New Area People's Government shall provide policy support and protection for drug testing and inspection organizations to enhance the testing and inspection capabilities.

Pudong New Area should strengthen the construction of biomedical product registration guidance service workstation. For drugs and medical devices in line with the direction of industrial development, the registration guidance service workstation should be timely tracking, docking registration progress, to carry out the registration of drugs and medical devices pre-guidance services, to promote the accelerated listing of drugs and medical devices.

Article 18 The city supports the State Drug Administration drug evaluation and inspection of the Yangtze River Delta sub-center, the Yangtze River Delta sub-center for the technical evaluation and inspection of medical devices, to assist in the configuration of professional and specialized reviewers, inspectors, and the establishment of a scientific, efficient and professional review and inspection work mechanism.

The relevant departments of the city and Pudong New Area should rely on the State Drug Administration Drug Evaluation and Inspection of the Yangtze River Delta Sub-centers, Medical Device Technical Evaluation and Inspection of the Yangtze River Delta Sub-centers, to provide efficient and convenient guidance and services for biomedical enterprises, and to promote the incorporation of innovative medicines and medical devices into the priority review and approval channels in accordance with the relevant provisions. To accelerate the registration and listing of innovative drugs and medical devices.

Article 19 The city supports the use of innovative drugs and medical devices into medical institutions. The city and the relevant departments of Pudong New Area on the Pudong New Area medical institutions to purchase and use of innovative drugs and medical devices are not included in the proportion of drugs (consumables) revenue, the total number of varieties of specifications of drugs, the procurement of proportional limitations and other assessments.

Article 20 The city supports universities, research institutes, medical institutions and biomedical enterprises in Pudong New Area to carry out cooperation, through the construction of laboratories, research institutes and other ways to promote the construction of innovative collaborative industrial ecosystem. The city supports the construction of national and municipal pharmaceutical clinical research centers, explore the pilot construction of research hospitals in Pudong New Area, promote the docking of scientific and technological achievements and clinical research, and promote the deep integration of industry, academia, research and medicine.

Pudong New Area science and technology, economic and health departments should carry out innovative drugs and medical devices R & D project evaluation work, relying on the city's hospitals and enterprises to collaborate on clinical trial acceleration platform, to promote the clinical trial demand docking, to enhance the quality of integration between industry and medicine efficiency.

Article 21 Encourage all types of health care institutions to promote health care data collection, storage, strengthen the application of support and operation and maintenance technology protection. Accelerate the construction and improvement of residents' electronic health records, electronic medical records, electronic prescriptions, etc. as the core of the basic database.

The health departments of the city and Pudong New Area should establish a healthcare data sharing and opening mechanism in accordance with relevant laws and regulations, formulate classification and grading standards for the opening up of healthcare data, promote the orderly opening up of healthcare data, and provide data support for the innovative research and development of biomedicine in the city.

Article 22 The city supports the construction of a high-standard, intensive biospecimen library in Pudong New Area.

The municipal health department and the people's government of Pudong New Area shall establish an effective mechanism for the application and sharing of biological samples for research, and support enterprises to take the lead in or participate in the development of the construction and management standards of the sample bank. The city and Pudong New Area health departments should strengthen the guidance of storage and management of biological samples and their information data, and ensure that the collection, storage, use, and sharing of biological samples are in line with biosafety management standards.

Biological samples from healthcare institutions can be entrusted to a third-party organization with relevant qualifications for centralized storage and management.

Article 23 The city supports the construction of the Zhangjiang Comprehensive National Science Center, promotes the planning and construction of large-scale scientific facilities, improves the protection of the use of facilities, and strictly manages the management of facilities around the development of the biomedical industry to provide basic research and protection.

Article 24 For qualified new biomedical research and development institutions, the relevant departments of the city and Pudong New Area shall provide guidance and support in their management mode, achievement transformation, institutional reform and other aspects.

The Pudong New Area People's Government shall support the construction of open innovation centers for qualified biomedical enterprises. For qualified innovation centers, they shall provide support in construction and operation, talent incentives, and intellectual property protection.

Article 25 The city encourages all kinds of market players to build crowdsourcing spaces, incubators, gas pedals and other biomedical shared public service platforms, innovative service models, for the different stages of development of innovative enterprises to provide a sound infrastructure, targeted operations and management and professional R & D services, strengthen the It will also strengthen the synergy between industrial parks, innovative R&D enterprises and R&D and production service enterprises.

Article 26 The city promotes the deep integration of the innovation chain, industrial chain and talent chain of the biomedical manufacturing industry. Encourage the core enterprises of the biomedical industry chain to lead the industry chain supply chain to continue to advanced, modernization and development, to create a number of key core technologies of biomedical leading enterprises.

Article 27 The city established the Pudong New Area biomedical project information database and dynamic updating, innovative research and development results of the orderly transformation of the benefit-sharing mechanism, to achieve synergistic development of the city's biomedical innovation, research and development and manufacturing.

Article 28 For key projects in line with the development of the biomedical industry, the city and the relevant departments of the Pudong New Area can be optimized in accordance with the provisions of the land use, floor area ratio, building height and so on.

City and Pudong New Area planning and resource departments should deepen the industrial land "standardized" transfer mode reform, to increase the supply of mixed industrial land. Under the premise of conforming to the industrial function orientation and the dominant industrial use of the biomedical project, the pilot biomedical industry land in Pudong New Area allows the assignee to determine the proportion of industrial use of the land independently.

Article 29 The city in line with the provisions of the biomedical innovation products to implement the first purchase and ordering system. Pudong New Area to improve the priority use of biomedical innovation products of government procurement policies, increase the biomedical innovation products of government procurement efforts to promote the research and development of biomedical innovation products and demonstration and application.

Article 30 The local financial regulators of the city, the people's government of Pudong New Area shall innovate the financial service model of the biomedical industry, promote the listing of biomedical enterprises in the science and technology innovation board and other capital markets; continue to optimize the sample of the Zhangjiang Index and the weight, highlighting the biomedical industry of Zhangjiang National Innovation Demonstration Zone, guide the capital market to support Zhangjiang's advantageous industries. The sample and weight of Zhangjiang Index will be continuously optimized, highlighting the advantageous industries in Zhangjiang National Innovation Demonstration Zone, and guiding the capital market to support the development of biomedical industry in Zhangjiang.

Municipal finance and local financial regulators should increase their guidance on biomedical supply chain finance, focusing on supporting financial institutions to develop supply chain financial products around the core enterprises in the biomedical supply chain that are suitable for the needs of industrial development, and providing services for financing small and medium-sized enterprises upstream and downstream of the biomedical industry chain.

The city plays the role of Shanghai's small and medium-sized micro-policy financing guarantee fund, and guides the relevant financial institutions and financing guarantee institutions to provide credit enhancement services for the financing of biomedical enterprises in the Pudong New Area through batch guarantees, joint guarantees, and re-guarantees in a variety of ways.

Article 31 The Pudong New Area ecological environment department can work with the science and technology economic sector in accordance with the ecological protection of the red line, the environmental quality of the bottom line, the utilization of resources on the line and the ecological environment access list of the ecological environment zoning control requirements of the antibody, vaccines, blood products and other biologics in the field of construction projects, according to the regional environmental sensitivity, construction, and the use of the blood products. The degree of environmental sensitivity of the region, the possible environmental impact of construction projects and environmental risks, the development of ecological and environmental management measures for subsectors, the implementation of differentiated supervision.

Article 32 Pudong New Area biomedical research and development institutions, medical institutions can be obtained in accordance with the law of the function of scientific and technological achievements of intellectual property rights or intellectual property rights of the long-term use of the right to give results to the completion of the person.

Pudong New Area to set up a biomedical professional title review committee, the region's non-public sector of the biomedical industry professional and technical personnel to carry out the evaluation of professional and technical personnel; according to the national authorization to develop and publish a list of international vocational qualifications certificates recognized, and to study the international vocational qualifications and the domestic title of the convergence of the approach.

Pudong New Area biomedical research and development institutions, medical institutions, professional and technical personnel in other enterprises, institutions, part-time or the use of scientific and technological innovation results related to their own professional work on the job to establish enterprises, the relevant rights and obligations of the unit by the provisions of their units, or by the unit and the professional and technical personnel agreed.

Article 33 The city to implement the national biosafety strategy, the establishment of a sound biosafety risk monitoring and early warning system, improve the biosafety research mechanism, to promote the city's biosafety technology and its industrial application to lead the development.

Article 34 The provisions of this regulation shall come into force on January 1, 2022.