Provisions of Pudong New Area of Shanghai Municipality on Promoting the Development of Zhangjiang Innovation Hub of the Biopharmaceutical Industry

(Adopted at the 38th Session of the Standing Committee of the 15th Shanghai Municipal People's Congress on December 29, 2021；amended for the first time in accordance with the Decision on Amending the Regulations of Shanghai Municipality on the Administration of Highways and Nine Other Local Rules adopted at the 18th Session of the Standing Committee of the 16th Shanghai Municipal People's Congress on December 31, 2024; amended for the second time in accordance with the Decision on Amending Two Local Rules including the Provisions of Pudong New Area of Shanghai Municipality on Promoting the Development of Zhangjiang Innovation Hub of the Biopharmaceutical Industry adopted at the 21st Session of the Standing Committee of the 16th Shanghai Municipal People's Congress on April 29, 2025)

Article 1

With a view to giving full play to the planning and sources of biopharmaceutical scientific innovation and the advantages of industrial ecology led by Zhangjiang, satisfying the requirements of national strategies, promoting the high-quality development of the biopharmaceutical industry in Pudong New Area, stimulating the formation of world-class biopharmaceutical industry clusters in Pudong New Area, and better meeting people's needs for a healthy life, these Provisions are formulated in accordance with the basic principles of relevant laws and administrative rules, and in the light of the actual circumstances of Pudong New Area.

Article 2

These Provisions apply to the biopharmaceutical research and development, production, operation, use, and the promotion and guarantee thereof within the administrative area of Pudong New Area.

Article 3

This Municipality shall promote the high-quality development of the biopharmaceutical industry in Pudong New Area, in accordance with the principles of system leadership, reform and innovation, people-orientation, opening and cooperation, risk prevention, scientificity and standardization.

Article 4

The Municipal People's Government shall exercise a stronger leadership in the development of the biopharmaceutical industry in Pudong New Area, establish and improve the consultation and coordination mechanism to promote the development of the biopharmaceutical industry, strengthen the cooperation with the related state departments, and conduct overall coordination for the major issues concerning the development of the biopharmaceutical industry in Pudong New Area.

Pudong New Area People's Government shall provide a mechanism to promote the development of the biopharmaceutical industry in Pudong New Area, strengthen the development of the biopharmaceutical industry led by Zhangjiang, and stimulate the innovation and development of the biopharmaceutical industry in Pudong New Area.

Relevant town people's governments, sub-district offices, and industry park administration organizations in Pudong New Area shall, in accordance with their functions and duties, do a good job in encouraging and ensuring the development of the biopharmaceutical industry.

Article 5

The municipal department of science and technology shall be responsible for the development coordination of the biopharmaceutical industry in this Municipality, and coordinate and promote the development of Pudong New Area as the innovation hub of the biopharmaceutical industry. The science and technology department of Pudong New Area shall be responsible for the specific work of constructing an innovation hub of the biopharmaceutical industry in Pudong New Area.

This Municipality's and Pudong New Area's departments of development & reform, science and technology, commerce, health, medical products administration, healthcare, finance, planning and resources, ecology and environment, human resources and social security, financial regulatory, landscaping and city appearance, and units such as customs shall be responsible for the promotion of the development of the biopharmaceutical industry in Pudong New Area, in accordance with their respective functions and duties and these Provisions.

Article 6

Pudong New Area People's Government shall establish an expert committee for the development of the biopharmaceutical industry in Pudong New Area. The expert committee shall be responsible for conducting scientific proofs of and offering opinions and suggestions for the issues related to the development, project planning, and key layout of the biopharmaceutical industry in Pudong New Area. The expert committee's opinions and suggestions shall serve as an important reference for the decision-making of the development of the biopharmaceutical industry.

Article 7

The people's governments of this Municipality and Pudong New Area shall include the promotion of the development of the human cell and gene industry into the coordination and promotion mechanism for the development of the biopharmaceutical industry, and on the premise of controllable risks, support qualified diversified investors to conduct research and development on human cell and gene technologies and to stimulate the industrialization process thereof.

The departments of science and technology, and health of this Municipality and Pudong New Area, shall tighten the regulation on the development and application of human cell and gene technologies conducted by biopharmaceutical enterprises in Pudong New Area, and shall strengthen the risk control thereof.

Article 8

With regard to biopharmaceutical enterprises in Pudong New Area within the scopes permitted by the relevant state departments, the implementation of bonded supervision of goods (including materials, consumables, reagents, etc.) required for cross-border research and development shall be explored.

In accordance with the requirements of the regulation departments that information shall be shared and risks shall be controllable, the relevant key biopharmaceutical enterprises in Pudong New Area may carry out medical equipment bonded maintenance and repair businesses with high-added value and high technology content and satisfying environmental protection requirements; the relevant enterprises in the specific areas of Pudong New Area may conduct the maintenance and repair of exported high-end medical equipment back in the Chinese mainland, in accordance with the applicable provisions issued by the State. The medical equipment shall be re-shipped abroad according to its source after the maintenance and repair.

Article 9

Where a biopharmaceutical enterprise in Pudong New Area with the conditions of commercial-scale medication production which complies with the medication manufacturing quality management standards applies for a medication manufacturing permit during clinical trials, the municipal medical products administration department may issue the Medication Manufacturing Permit if the enterprise assures that the production conditions of clinical test samples are consistent with the production conditions during the stage of application for marketing.

Article 10

A medication marketing permit holder in Pudong New Area may produce medication on its own, or commission medication manufacturers to produce medication. With the confirmation and approval of the national medical products administration department, a medication marketing permit holder in Pudong New Area may commission more than one qualified medication manufacturer in this Municipality to produce medication. The municipal medical products administration department shall provide proper guidance and services, and cooperate with the national medication department to conduct relevant examinations.

Blood products, narcotics, psychotropic substances, medicinal toxic drugs, and pharmaceutical precursor chemicals shall not be commissioned to produce, except as otherwise specified by the national medical products administration department.

Article 11

With regard to an in vitro diagnostic reagent without similar products available in this country, an eligible medical institution in Pudong New Area may develop the reagent on its own for clinical use, and use it in the institution under the guidance of licensed physicians. The specific procedures shall be formulated by the municipal medical products administration department, in conjunction with the municipal health department.

Article 12

The Municipal People's Government may, within the scopes authorized by the State, approve the qualified medical institutions in Pudong New Area to import a small quantity of urgently needed clinical medicines and medical equipment. The imported medicines and medical equipment shall be used for specific medical purposes in designated medical institutions.

The qualified biopharmaceutical enterprises shall be encouraged to conduct research on the application of real-world clinical data of the small quantity of imported urgently needed clinical drugs and medical equipment, to explore the use of clinical real-world data for medicine and medical equipment registration, and to accelerate the marketing of the medicines and medical equipment.

Article 13

Where a drug undergoing clinical trial for the treatment of a severely life-threatening disease with no existing effective therapy indicates potential therapeutic benefits for the patient upon medical observation and complies with ethical requirements, after review, disclosure to the patient, and obtaining informed consent, such drug may be used within the medical institutions in which such trial is conducted on other patients who share the same medical conditions and are unable to participate in the clinical trial.

Article 14

This Municipality shall, in accordance with the authorization of the State, launch pilot programs in the relevant areas for the eligible transaction platforms of medicines and medical equipment in Pudong New Area to conduct cross-border e-commerce retail import business of certain medicines and medical equipment.

The municipal medical products administration department shall, on the basis of the actual needs of the development of the biopharmaceutical industry in Pudong New Area, optimize the implementation of medicine wholesale permits and fulfill the needs of modern medication logistics, on the premise of safe and controllable quality of operation.

Article 15

This Municipality shall, in accordance with the demands of biopharmaceutical enterprises in Pudong New Area for research and development, plan and construct quarantine stations for imported non-human primates and other experimental animals.

Pudong New Area shall encourage nongovernmental capital to invest and carry out according to law the activities in the species protection, breeding, production, and supply of non-human primates and other experimental animals and products thereof connected to biopharmaceutical research and development, so as to fulfill the needs of biopharmaceutical research and development. Where non-human primates and other experimental animals need to be bred and used, it shall be approved by the science, technology and economy department and the competent department for wild animal protection of Pudong New Area, and the licenses for breeding and using experimental animals shall be obtained according to law.

The health department and the agriculture and rural affairs department of Pudong New Area shall be jointly responsible for filing the construction, renovation, and expansion of human health-related animal biosafety laboratories level-2 in Pudong New Area.

Article 16

This Municipality shall establish a joint supervision mechanism for the import and export of special biopharmaceutical articles including microorganisms, human tissues, biological products, and blood and its derivatives. Pudong New Area People's Government shall, in conjunction with relevant departments, comprehensively assess the biopharmaceutical enterprises and their imported and exported special articles, and issue the corresponding certificates of the biosecurity control capability for the enterprises and articles that pass the assessment. On the basis of the certificates and other files submitted by such enterprises, Shanghai Customs shall simplify the customs clearance procedures.

This Municipality shall establish a joint pilot promotion mechanism for importing the articles for biopharmaceutical research and development. Pudong New Area People's Government shall, in conjunction with the relevant departments, identify the enterprises and the imported articles for research and development. The qualified enterprises and articles shall not be required to submit the Notice of Customs Clearance for Imported Drugs for customs clearance procedures.

Pudong New Area shall set up a management service platform for enterprises to import a trace amount of consumables for research and development, and provide support in terms of import license, customs clearance, and permission for distribution.

Article 17

This Municipality shall establish a human genetic resources management service organization in Pudong New Area to carry out the activities related to human genetic resources, including consulting, services, training, research, etc., and to assist the human genetic resources management administrative organizations of the State and this Municipality to exercise ongoing and ex post oversight of human genetic resources.

Article 18

Designated by the national medical products administration department, medication inspection and testing institutions within the administrative area of Pudong New Area may carry out registration and inspection of innovative drugs. The municipal medical products administration department and Pudong New Area People's Government shall provide the medication inspection and testing institutions with policy support and guarantee to improve their inspection and testing capabilities.

Pudong New Area shall enhance the construction of registration guidance service workstations for biopharmaceutical products. For the medicines and medical equipment in line with the direction of industrial development, the registration guidance service workstations shall promptly track and coordinate the registration process, provide preliminary guidance services for the medicines and medical equipment registration, and accelerate the launch of medicines and medical equipment.

Article 19

This Municipality shall support the construction of the Yangtze River Delta Branch Center for Drug Evaluation, and the Yangtze River Delta Branch Center for Medical Equipment Evaluation of the National Medical Products Administration, assist in the allocation of professional evaluators and inspectors, and establish a scientific, efficient and professional evaluation and inspection mechanism.

The relevant departments of this Municipality and Pudong New Area shall, dependent on the Yangtze River Delta Branch Center for Drug Evaluation, and the Yangtze River Delta Branch Center for Medical Equipment Evaluation of the National Medical Products Administration, provide the biopharmaceutical enterprises with efficient and convenient guidance and services, prioritize the evaluation and approval of innovative drugs and medical equipment under the relevant provisions, and accelerate the registration and launch of innovative drugs and medical equipment.

Article 20

The medical products administration department of Pudong New Area shall, entrusted by the municipal medical products administration department, implement licensing for manufacturing category II and category III medical device in accordance with law, and conduct supervision and inspection on production activities of relevant enterprises according to its respective functions and duties. The municipal medical products administration department shall strengthen guidance and supervision.

Article 21

This Municipality shall support medical institutions to use innovative drugs and medical equipment. The relevant departments of this Municipality and Pudong New Area shall not include the innovative drugs and medical equipment procured and used by the medical institutions in Pudong New Area into the assessment of the proportion of medication (consumables) revenue, the total number of drug varieties and specifications, the procurement proportion limitation and other items.

Article 22

This Municipality shall support colleges, universities, research institutes, and medical institutions to cooperate with biopharmaceutical enterprises in Pudong New Area in the promotion of the construction of an innovation and collaboration industry ecosystem by jointly building laboratories and research institutes. This Municipality shall support the construction of the national and municipal medication clinical research centers, explore the pilot construction of research hospitals in Pudong New Area, promote the connection between scientific and technological achievements and clinical research, and stimulate further integration among the industry, education institutions, research institutions, and medical institutions.

The science, technology and economy, and health departments of Pudong New Area shall assess the research and development projects of innovative drugs and medical equipment, and, dependent on the hospital-enterprise collaborative platform for clinical trial acceleration of this Municipality, and promote the connection of clinical trial demands to improve the quality and efficiency of the integration of the industry and medical institutions.

This Municipality supports eligible medical institutions in carrying out clinical research and clinical trials on relevant technologies and products of biopharmaceutical enterprises in Pudong New Area, optimizing the management process to improve the quality and efficiency of clinical research and clinical trials.

Article 23

Various medical institutions shall be encouraged to collect and store health and medical data, and to strengthen the application support and the technical guarantee for operation and maintenance. The construction and improvement of the foundation databases with the residents' electronic health records, electronic medical records, and electronic prescriptions as their core data shall be accelerated.

The health departments of this Municipality and Pudong New Area shall, in accordance with the relevant laws, rules and regulations, establish a health and medical data sharing mechanism, and formulate the classification and grading standards for open health care data, to promote the orderly opening of health and medical data so as to provide data support for the biopharmaceutical innovation and research and development in this Municipality.

Article 24

This Municipality shall support the construction of a high-standard and intensive biological sample bank in Pudong New Area.

The municipal health department and Pudong New Area People's Government shall establish an effective mechanism for the research application and sharing of biological samples, and support enterprises to take the lead or participate in the formulation of the construction and management standards for the sample bank. The health departments of this Municipality and Pudong New Area shall strengthen their guidance on the storage and management of biological samples and data thereof to ensure that biological samples are collected, stored, used, and shared in accordance with the biosecurity management norms.

The biological samples of medical institutions may be entrusted to qualified third-party institutions for collective storage and management.

Article 25

This Municipality shall support the construction of Zhangjiang comprehensive national science center, promote the planning and construction of equipment for big science, improve the facility use protection, and tighten the management of the areas around the facilities to provide basic research and guarantee for the development of the biopharmaceutical industry.

Article 26

As for qualified new-type biopharmaceutical research and development institutions, the relevant departments of this Municipality and Pudong New Area shall provide them with guidance and support on such aspects as management models, achievement transformation and system reforms.

Pudong New Area People's Government shall support the competent biopharmaceutical enterprises to set up open innovation centers. The qualified innovation centers shall be supported in terms of construction and operation, talent rewards, and intellectual property protection.

Article 27

This Municipality shall encourage all market participants to build biopharmaceutical shared public service platforms such as maker spaces, incubators, and accelerators, innovate new service modes, provide innovative enterprises at different development stages with a complete range of infrastructure, targeted operation management, and professional research and development services, and strengthen the coordination and interactions among industry parks, innovative research and development enterprises, and those for R&D and production service.

Article 28

This Municipality shall promote the close integration among the innovation chain, the industry chain, and the talent chain in the biopharmaceutical manufacturing industry. The core enterprises in the biopharmaceutical industry chain shall be encouraged to take the lead in driving the industry chain and the supply chain to be further advanced and modernized, and a number of biopharmaceutical leading enterprises with key and core technologies shall be created.

Article 29

This Municipality shall establish a biopharmaceutical project information database in Pudong New Area and update it dynamically, and innovate a benefit-sharing mechanism for the orderly transformation of research and development achievements, to realize the coordinated development of the biopharmaceutical innovative research and development and manufacturing in this Municipality.

Article 30

With regard to a significant project that is in line with the development orientation of the biopharmaceutical industry, the relevant departments of this Municipality and Pudong New Area shall optimize the land use, plot ratio, and building height, etc. in accordance with the provisions.

The planning and resources departments of this Municipality and Pudong New Area shall deepen the reform of "standardized" modes of transferring industrial land, and increase the supply of the mixed industrial land. On the premise of being in line with the industrial function orientation and the biomedical projects' dominating the industrial use, these departments shall conduct pilot use of the biopharmaceutical industrial land in Pudong New Area allowing the transferees of the land independently determine the industrial proportion of industrial use of land.

Article 31

This Municipality shall implement the purchase and order system to the qualified innovative biopharmaceutical products. Pudong New Area shall improve the government procurement policies of giving priority to the use of innovative biopharmaceutical products, increase government procurement of the innovative biopharmaceutical products, and promote the research and development and demonstrative application of the innovative biopharmaceutical products.

Article 32

The financial regulatory department of this Municipality and Pudong New Area People's Government shall innovate financial service modes of the biopharmaceutical industry, and support biopharmaceutical enterprises to be listed on capital markets such as the SSE Star Market; continuously optimize the samples and weights of the Zhangjiang Indexes, highlight the competitive industries in the Zhangjiang National Independent Innovation Demonstration Zone, such as the biopharmaceutical industry, and guide the capital market to support the development of the biopharmaceutical industry in Zhangjiang.

The municipal finance department and financial regulatory department shall strengthen the guidance on the biopharmaceutical supply chain finance, and prioritize the support for financial institutions to develop supply-chain financial products suitable for the industrial development needs for the core enterprises of the biopharmaceutical supply chain, and provide financing services for small and medium-sized enterprises in the upstream and downstream of the biomedical industry chain.

This Municipality shall give full play to the Shanghai Policy Financing Guarantee Funds for SMEs, and guide the relevant financial institutions and financing guarantee institutions via multiple methods such as batch guarantees, joint guarantees, and re-guarantees to provide the biopharmaceutical enterprises in Pudong New Area with credit enhancement services.

Article 33

The ecology and environment department of Pudong New Area may, in conjunction with the science, technology and economy department, in accordance with the requirements for the ecology and environment zoning management and control of the ecological protection redline, environmental quality bottom line, resource utilization ceiling and ecology and environment access list, formulate ecological and environmental management measures of the subdivided industries for the construction projects in the field of biological products such as antibodies, vaccines, blood products and other biological products on the basis of the environmental sensitivity of the located areas and the potential environmental impact and risks of the construction projects.

Article 34

The biopharmaceutical research and development institutions and medical institutions in Pudong New Area may grant the achievement accomplishers the intellectual property rights or the long-term right of use of the intellectual property rights of the job-related scientific and technological achievement legally obtained.

Pudong New Area shall set up an evaluation committee for biopharmaceutical professional titles to carry out professional titles evaluation for the professional and technical talents in the non-public biopharmaceutical industry within the area, draw up and publish a recognition list of international professional qualifications as authorized by the State, and study the measures for connecting international professional qualifications and domestic titles.

Where a professional of a biopharmaceutical research and development institution or medical institution in Pudong New Area holds a part-time position in another enterprise or institution or starts a business on the job with the scientific and technological innovation achievements related to his/her profession, the relevant rights and obligations shall be regulated by his/her employer or agreed between the employer and the professional.

Article 35

This Municipality shall implement the national biosecurity strategy, establish and improve a monitoring and warning system of biosecurity risks, improve the mechanism for tackling key problems in biosecurity research, and promote the pioneering development of biosecurity technologies and industrial applications thereof in this Municipality.

Article 36

Biopharmaceutical-related industry organizations in Pudong New Area shall, in accordance with laws, rules, and their charters, play a coordinating and self-regulatory role, convey demands within the industry in a timely manner, and provide services to their members in such areas as information consulting, publicity and training, market development, rights protection, and dispute resolution.

Article 37

These Provisions shall be effective as of Jan 1, 2022.