Source: Shanghai Drug Administration/Shanghai People's Congress

On March 1, 2025, the Regulations of Shanghai Municipality on the Administration of Drugs and Medical Devices came into effect. This is the country's first local regulation to comprehensively regulate the research and development, production, marketing and use of drugs and medical devices. The Regulation has a total of seven chapters and 54 points, focusing on the perception of the masses and enterprises, through the clinical trial stage can apply for drug production licenses, optimize the import and local transfer procedures of medical devices outside the city, accelerate the production of products and enhance the sense of enterprise gain; By optimizing the inspection dosage of imported rare disease drugs, allowing the import and sale of commercial-scale batches of drugs that meet the requirements, etc., promoting the rapid marketing of products and meeting the needs of the masses. Focus on new technologies, new formats and new models, improve the management system for commissioned production, segmented production, network platform trading, medical device production facilities and equipment sharing, clarify production and operation requirements, and improve enterprise management level; For innovative products such as cell and gene therapy, we will encourage the improvement of originality, leadership, and strategic scientific and technological research, and promote the effective transformation and application of results. Focusing on ** service and innovation supervision, it proposed to strengthen the guidance of registration pre-service, improve the classification of "risk + credit" supervision, cross-level and cross-department comprehensive supervision, smart supervision, clarify the responsibilities of domestic agents for imported medical devices, clarify the responsibilities of the Food and Drug Safety Commission, and strengthen the territorial management responsibilities of pharmaceutical equipment. Regulations of Shanghai Municipality on the Administration of Drugs and Medical Devices (Adopted at the 18th Meeting of the Standing Committee of the 16th Shanghai Municipal People's Congress on December 31, 2024) ** Chapter General Provisions ** Article In order to strengthen the administration of drugs and medical devices, ensure the quality of drugs and medical devices, and promote the innovation and development of drugs and medical devices, To safeguard public health and life, these Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on Traditional Chinese Medicine, the Regulations on the Supervision and Administration of Medical Devices and other laws and administrative regulations, and in light of the actual conditions of this Municipality.

Article 2 These Regulations shall apply to the research, production, distribution and use of drugs and medical devices and their supervision and administration activities within the administrative area of this Municipality.

Article 3 The administration of drugs and medical devices in this Municipality shall take people's health as the center, adhere to the principles of risk management, whole-process control, scientific supervision, social co-governance, encouragement of innovation and service development, and ensure the integrity, effectiveness and accessibility of drugs and medical devices.

Article 4 The municipal and district people's governments shall be responsible for the administration of drugs and medical devices within their respective administrative areas, uniformly lead, organize and coordinate the administration of drugs and medical devices within their respective administrative areas and the response to emergencies, establish and improve the management mechanism and information sharing mechanism, and incorporate the administration of drugs and medical devices into the national economic and social development plan. Strengthen regulatory capacity building to ensure the safety of drugs and medical devices.

Article 5 The Food and drug Commission established by the municipal and district people's governments is specifically responsible for the research and deployment, overall guidance for the work of drugs and medical devices, urging the implementation of drug management responsibilities, coordinating and guiding major drug and medical device trafficking incidents, the handling of major illegal cases and other responsibilities assigned by the municipal and district people's governments.

Article 6 The municipal drug regulatory department and the department responsible for drug supervision of the district people's government (hereinafter referred to as the drug regulatory department) shall be responsible for the supervision and administration of drugs and medical devices within their respective administrative areas.

Health care, medical security, science and technology, commerce, market supervision, intellectual property rights, ecological environment, agriculture and rural areas and other departments shall jointly manage relevant work according to their respective responsibilities.

Article 7 Those engaged in the development, production, marketing and use of drugs and medical devices shall comply with the provisions of relevant laws and administrative regulations, and meet the requirements of non-clinical research, clinical trials, clinical evaluation, registration (filing), production management, management of operation and use, and biological innovation.

Article 8 The holder of a drug marketing authorization, the registrant or recordholder of a medical device shall establish a system for quality management, risk prevention and control and the handling of illegal incidents, and be responsible for the safety, effectiveness and quality control of drugs and medical devices according to law.

Article 9 Drug and medical device-related industry organizations shall provide members with information, training, technology and other services, establish and improve industry norms, strengthen industry self-discipline and industry integrity construction, guide members to carry out drug and medical device-related activities according to law, and promote the healthy development of the industry.

Article 10 This Municipality shall establish a communication and cooperation mechanism for drug and medical device management with relevant provinces and municipalities in the Yangtze River Delta region, strengthen cooperation in review and approval, regulatory law enforcement, credit management, risk prevention and control, emergency response, etc., and promote the construction of a regulatory system with unified drug and medical device standards, data sharing, mutual recognition of results and joint work in the Yangtze River Delta region.

The city supports exchanges, cooperation and coordinated development with other regions in the field of medicine and medical devices.

The city strengthens international exchanges and cooperation in drugs and medical devices, and promotes R&D innovation and industrial internationalization.

Chapter II Research, Development and innovation Article 11 This Municipality encourages research and innovation in drugs and medical devices, supports basic research and applied research, and promotes original innovation.

Enterprises, scientific research institutions, medical and health institutions, universities and other institutions are encouraged to carry out innovative research and development oriented by clinical value, integrate and share resources, and promote the transformation, promotion and application of new technologies.

Article 12 Clinical trial sponsors and clinical trial institutions shall comply with the procedures and requirements stipulated by the State to conduct clinical trials of drugs and medical devices, ensure that the data and results are scientific, true and reliable, and protect the rights and interests of the subjects.

The municipal drug regulatory department shall carry out clinical trial quality monitoring, find that there may be illegal problems or other risks, give early warning, carry out risk assessment, and handle according to law.

Encourage clinical trial sponsors to conduct multi-center clinical trials of drugs and medical devices in different countries or regions;

Encourage clinical trial institutions to participate in international multi-center clinical trials of drugs and medical devices.

Article 13 This Municipality shall, in accordance with the provisions of the State, support qualified enterprises, scientific research institutions, medical institutions and institutions of higher learning to cooperate in the clinical trials of cell and gene therapy drugs, promote the effective accumulation of real-world data, improve the quality and applicability of data, and provide support for product registration.

Encourage companies to develop the best products that cover clinical trials of cell and gene therapy drugs; Support insurance for the best products suitable for clinical trials of cell and gene therapy drugs.

Article 14 The municipal science and technology department shall establish a collaborative research and innovation platform with the municipal health and other departments, promote the docking of clinical trial needs between medical and health institutions and enterprises, improve the quality and efficiency of the integration of production and medicine, and accelerate the research and development of drugs and medical devices.

Article 15 This Municipality promotes the establishment of an ethical collaborative review mechanism for medical and health institutions, carries out ethical collaborative review for multi-center clinical trials, and promotes mutual recognition of ethical review results.

Article 16 Drugs and medical devices shall be registered and put on record in accordance with the procedures and requirements prescribed by laws and administrative regulations. The municipal drug regulatory department optimizes technical guidance, communication and other services in the aspects of review, approval, inspection and testing.

The municipal drug regulatory department strengthened the pre-guidance for the registration of drugs and medical devices with obvious clinical value and innovation, and cooperated with the coordination and guidance of major biomedical industry projects.

The municipal drug regulatory department, together with the municipal science and technology department, shall guide the industrial gathering areas to provide consulting guidance for enterprises through the establishment of service stations and online services.

Article 17 This Municipality supports the construction of the Yangtze River Branch Center for Drug Evaluation and Inspection of the State Drug Administration and the Yangtze River Branch Center for medical device technical evaluation and inspection, provides guidance services for registration and filing applicants, and speeds up the registration and listing of products.

Article 18 This Municipality shall strengthen the protection of intellectual property rights of drugs and medical devices, improve the patent rapid examination service mechanism for innovative drugs and medical devices, and encourage innovative research and development of drugs and medical devices.

Article 19 Category II medical devices with obvious clinical value and strong innovation may apply to the municipal drug regulatory department for the application of innovative product registration procedures.

Category II medical devices under any of the following circumstances may apply to the municipal drug regulatory department for priority registration procedures: (1) those that diagnose or treat rare diseases; (b) suitable for the elderly and multiple diseases and there is no effective diagnosis or treatment means, or special for children and has obvious clinical advantages; (3) no products of the same variety have been approved for registration in China and have obvious clinical advantages, or the same variety has been approved for registration in China less and cannot meet clinical needs; (4) included in the national major science and technology projects, key research and development plans or this Municipality's major science and technology projects, science and technology innovation action plan; (5) Other circumstances in which the preferential registration procedure may be applied.

When a public health emergency occurs, the municipal drug regulatory department shall include in the emergency registration procedure the second type of medical devices needed for emergency and for which there are no similar products on the market in China, or for which there are similar products on the market in China but the product supply cannot meet the needs of emergency response to public health emergencies.

The registration procedures, priority registration procedures and emergency registration procedures of the second type of medical device innovative products shall be separately formulated by the municipal drug regulatory department and shall be filed in accordance with the relevant provisions of the State.

Article 20 This Municipality shall establish a clinical research system, strengthen the cooperation between medical and health institutions and institutions of higher learning, scientific research institutions and enterprises, promote the research of cutting-edge technologies in the field of drugs and medical devices, and promote the transformation and application of results. Encourage the construction of research hospitals and research wards, equipped with scientific research teams suitable for clinical research, improve the clinical research management system and evaluation incentive mechanism, and enhance research capabilities and levels.

Encourage clinical research to be carried out in accordance with clinical trial quality management standards for drugs and medical devices, promote the connection between clinical research and clinical trial data, and provide support for product registration. If the State has other provisions on the quality control requirements of clinical research, such provisions shall prevail.

The municipal health department shall strengthen the monitoring, evaluation and analysis of clinical research, and implement supervision and management.

Article 21 The municipal Department of Commerce shall, together with the municipal departments of drug supervision, ecological environment, agriculture and rural areas, science and technology, establish a joint promotion mechanism for the import of biomedical research and development and testing articles. For biopharmaceutical research and development units, pharmaceutical and medical device enterprises to import raw materials, compounds and other biopharmaceutical research and development articles that are not listed in accordance with drug approval at home and abroad, as well as micro testing standards imported by testing and monitoring institutions, optimize the customs clearance process and promote customs clearance facilitation.

The municipal science and technology department, together with relevant departments in accordance with the relevant regulations of the State and the Municipality, shall implement joint supervision on the entry and exit of relevant biomedical special goods, carry out comprehensive evaluation, and optimize the customs clearance process according to the evaluation opinions, and promote the facilitation of customs clearance. Chapter III Production Management Article 22 Where the municipal drug regulatory department guides qualified applicants for drug registration to complete pharmaceutical, pharmacotoxicological and other studies supporting the listing registration of drugs, determine quality standards, complete the verification of commercial scale production processes, and the confirmatory clinical trial data show that they are reliable and effective, To submit an application for the issuance of a drug production license or to increase the scope of production.

23rd medical device registration applicant has obtained import or domestic medical device product registration certificate of medical devices into the city for production, should be in accordance with the provisions of the product registration, production license. The municipal drug regulatory department, in accordance with its statutory duties, optimized the registration of production materials and production site verification procedures to improve the efficiency of review.

Article 24 Where a drug or medical device is commissioned for production, the holder of the drug marketing authorization, the registrant or the record holder of the medical device shall sign a quality agreement and a commissioned production agreement with the commissioned manufacturer, and strictly perform the obligations stipulated in the agreement.

Drug marketing authorization holders, medical device registrants or recordholders shall do a good job of product marketing release and post-listing change management, regularly organize the production quality risk assessment and put forward corrective and preventive measures to ensure that the production process meets the statutory requirements and quality control requirements.

The entrusted production enterprise shall organize production in accordance with laws and regulations, production quality management norms, mandatory standards, product technical requirements and entrustment agreements, and shall not entrust production again.

The holder of the drug marketing authorization, the registrant or record holder of the medical device, and the entrusted production enterprise shall strengthen the effective connection in the acceptance of materials into the factory, production inspection, deviation and change control, release review and other links.

Article 25 This Municipality shall, in accordance with the provisions of the State, explore the development of sub-commissioned production of drugs for innovative drugs with special requirements for production processes, facilities and equipment, drugs urgently needed for clinical needs or drugs urgently needed for public health emergencies.

Where segmented drug production is implemented, the holder of the drug marketing authorization shall establish a quality management system covering the whole process of research and development, production, testing, post-marketing monitoring and evaluation, and implement unified management of the commissioned production activities at each segmented production site to ensure that the production process meets the statutory requirements and quality control requirements.

Article 26 Where the production of cell therapy drugs is carried out in accordance with the provisions of the State, the holder of the drug marketing authorization and the entrusted manufacturer shall establish a quality management system and a digital traceability system covering the whole process of material acceptance, production, inspection to the release of the finished product, storage, transportation and handover, and establish a sound risk assessment system to effectively identify the risk factors affecting cell therapy drugs.

Article 27 This Municipality shall, in accordance with the provisions of the State, explore the listing of qualified commercial-scale batches of drugs.

After passing the conformity inspection of the pre-market drug production quality management standards and obtaining the drug registration certificate, the holder of the drug marketing authorization holding the drug production license can market the commercial-scale batch of drugs in accordance with the national regulations. The holder of a drug marketing authorization shall ensure that the said drug complies with the requirements for marketing release and strengthen risk control.

For imported drugs that have been listed abroad, for commercial-scale batches that meet the conditions prescribed by the State, the municipal drug regulatory department shall issue drug import customs clearance documents according to law.

The municipal drug regulatory department shall strengthen the supervision and administration of commercial-scale batch drug listing.

28th qualified medical device manufacturers share testing, process water and gas facilities and equipment, shall establish a unified production quality management system and maintain effective operation, strengthen daily management and quality control, to ensure that the production and testing process meet the legal requirements and standard requirements.

Article 29 This Municipality supports the production enterprises of TCM decoction pieces to establish planting and breeding bases in the authentic producing areas and main producing areas of TCM medicinal materials, promote the standardized planting and breeding of TCM medicinal materials, strengthen quality monitoring, and ensure the quality of the source of TCM decoction pieces.

TCM decoction pieces production enterprises shall establish a technical management system that conforms to the characteristics of TCM decoction pieces, produce TCM decoction pieces in accordance with the national drug standards and the municipal processing standards, and record the whole process of the production, inspection, storage, transportation and other links of TCM decoction pieces to ensure that the information can be traced.

This Municipality encourages the intensive production of TCM decoction pieces, supports the production enterprises of TCM decoction pieces to strengthen the research and development and application of technology and equipment, promotes the information construction and intelligent upgrading of production equipment, and improves the standardization level of the production process of TCM decoction pieces.

Article 30 An enterprise producing traditional Chinese medicine prepared pieces may, in accordance with the provisions of the State, purchase fresh cut Chinese medicinal materials from the place of origin for the production of traditional Chinese medicine prepared pieces.

Chinese medicine slices production enterprises shall extend the quality management system to the planting, harvesting, processing and other links of Chinese medicinal materials, to ensure that the processing enterprises in the origin of production in accordance with the quality management standards of pharmaceutical production, shall not be purchased while fresh cut Chinese medicinal materials directly packaged or changed packaging after sale.

31st in the China (Shanghai) Pilot Free Trade Zone and Lingang new area to import medical devices, domestic agents in line with the provisions of the state can under the effective control of the medical device quality management system,