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Biomedicine is the focus of fierce global competition in the field of life science and biotechnology, an important aspect of the country's new round of opening up to the outside world, and also a key area for the construction of China (Beijing) Pilot Free Trade Zone and the National Comprehensive Demonstration Zone for expanding the opening up of the service industry (hereinafter referred to as the "two zones" construction) to explore the opening up of the whole industrial chain。In order to speed up the formation of a new pattern of opening up the whole biomedical industry chain, create an innovative highland of the pharmaceutical industry with global influence, and promote the high-quality development of the municipal biomedical industry to a higher level, this plan is formulated。
一、总体要求
（一）指导思想
坚持以习近平新时代中国特色社会主义思想为指导，深入贯彻习近平总书记对北京重要讲话精神，坚持防风险与促提升相统一、补短板与锻长板相结合，主动迎接新一轮产业变革，We should accelerate institutional reform, optimize the application environment, strengthen the support for factors of production, strictly regulate industries, and deepen opening-up and cooperation，激发生物医药产业创新活力，提高国际竞争能力，推动生物医药产业高速、高端、高质量发展，打造具有全球影响力的生物医药产业创新高地。
（二）基本原则
Opening up on all fronts has taken a holistic approach to China's internal and external opening-up, expanded its scope, broadened its areas, and deepened its level, promoted fair competition, strengthened risk awareness and bottom-line thinking, and balanced development and security。
Focus on key points -- adhere to the priority of advantages, focus on the right direction, clear the timing, concentrate high-quality resources, support the accelerated development of key areas, quickly form scale effects, and build more first-mover leading advantages。
Institutional innovation - Strengthen resource integration, strive for the landing of national elements, effectively use foreign resources, give play to the enthusiasm of various subjects, and build a new pattern of integrated industrial development of government, industry, university and research。
Coordinated development -- Promoting regional cooperation, establishing mechanisms for sharing benefits and risks, promoting mutual support, mutual impetus and coordinated development among regions, and achieving mutual benefit and win-win development for all parties。
（三）工作目标
紧抓“两区”建设战略机遇，聚焦解决全产业链的关键难点和瓶颈问题，发挥首都资源优势和示范引领功能，推动重点环节、关键领域政策先行先试，实现创新资源加快聚集，开放措施更加有力，生产要素配置优化，监管机制显著提升，创新生态更加优良，To provide policy support for the leapfrog development of the city's biomedical industry and the construction of an internationally leading pillar industry，Build a "Beijing model" for the development of the national Free Trade Pilot Zone and the reform and opening up of the national biomedical industry。
二、主要措施
（一）扩大市场准入
We will strive for the support of relevant ministries and departments of the state, and on the premise of ensuring biosafety and data security, allow foreign investors to invest in the development and application of human stem cells, gene diagnosis and therapy technology in the China (Beijing) Pilot Free Trade Zone, and establish joint ventures to be controlled by the Chinese side。According to the authorization, foreign investors are allowed to set up wholly owned medical institutions in the China (Beijing) Pilot Free Trade Zone。To support Hong Kong and Macao service providers in setting up wholly owned medical institutions in the China (Beijing) Pilot Free Trade Zone。Establish a human genetic resources service station in this city, intervene in advance, give guidance before approval, and improve the efficiency of approval。
(Involved ministries and commissions: National Development and Reform Commission, Ministry of Commerce, National Health Commission, Ministry of Science and Technology;Municipal departments: Municipal Development and Reform Commission, Municipal Bureau of Commerce, Municipal Health Commission, Municipal Science and Technology Commission and Zhongguancun Administrative Committee respectively promote according to their duties)
（二）为创新企业开展国际医药研发合作提供便利
Support innovative enterprises in Shanghai to establish licensein/out cooperation models with international leading institutions to jointly develop innovative pharmaceutical devices and open the international market。Relying on the municipal intellectual property trading platform to carry out biomedical intellectual property and technology trading services, and accelerate the market flow of biomedical innovation elements。
(Municipal departments: Municipal Intellectual Property Office, Municipal Science and Technology Commission, Zhongguancun Administrative Committee and Municipal Food and Drug Administration respectively promote according to their duties)
（三）推动研发用物品通关便利化
Carry out the import pilot of biomedical research and development items, establish a "white list" system for the import of biomedical research and development items in biomedical enterprises (research and development institutions), one-to-one correspondence and dynamic adjustment of enterprises and items included in the "white list" of biomedical research and development items, and improve the degree of import facilitation。Support the city to adopt a new mode of one-pass approval and multi-place clinical trial supervision for the entry quarantine of humanized cells such as stem cells for clinical trials。After risk analysis and pilot evaluation, we will gradually simplify the import procedures of laboratory animals of SPF grade and above, and shorten the quarantine period。
(Involved ministries and commissions: General Administration of Customs, National Health Commission, State Food and Drug Administration;Municipal departments: Municipal Bureau of Commerce, Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Beijing Customs, Municipal Health Commission, Municipal Drug Administration, Haidian District, Changping District, Daxing District, Shunyi District, Economic development District respectively according to their responsibilities)
（四）加大对创新药械研发注册的支持力度
Support the establishment of experimental animal resource repositories and third-party human genetic resource storage platforms to provide support for new drug research and development, diagnosis and treatment technology, and pathogenesis research。Support the establishment of drug medical device innovation service stations in Beijing to provide consultation, communication, review and inspection green channels for the city's drug device registration。Support foreign-funded enterprises to transform imported Class II medical devices to apply for registration in Beijing, simplify the approval process, and streamline the application information。For the second category of medical software medical devices included in the rapid approval channel of innovative medical devices, further accelerate the review and approval, shorten the time to market of products, and support product iterative upgrading。Support the international level of pharmaceutical R&D outsourcing services, research and production outsourcing service platform construction。Actively guide and cultivate third-party testing institutions for medical devices, and support third-party testing institutions to continuously improve their testing capabilities and levels。对创新药械实施包容审慎监管。为科研机构和研发企业购买研发用药品提供便利服务。建立生物医药政策统一检索平台，加强政策导航和解读。
(Involved ministries and commissions: Ministry of Science and Technology, State Food and Drug Administration;Municipal departments: Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Municipal Drug Administration, Municipal Commerce Bureau, Municipal Economic and Information Technology Bureau, Municipal Market Supervision Bureau, Haidian District, Changping District, Daxing District, Economic development District respectively according to their responsibilities)
（五）建立重点管线“链长制”
Relying on the municipal pharmaceutical health collaborative innovation mechanism, the municipal leaders serve as the "chain length" of the biomedical industry chain, focusing on key pipelines such as vaccines, cell gene therapy, high-end medical devices, and AI medical treatment, and establishing "chain length" at the municipal level.。加强顶层设计，统筹内外资源，协调各个园区，持续精耕细作，Establish a full-life cycle service mechanism that closely links research and development, clinical, approval, industrialization, application and promotion，积极推进“延链、补链、强链”，打造龙头企业，培育更多专精特新中小企业，加速构建完整产业链条，促进上下游、产供销、大中小企业协同发展，We will build biomedicine into a strategic emerging industrial cluster with leading enterprises as the leader, independent and controllable key core technologies, and integrated development of large, small and medium-sized enterprises。
(Municipal departments: Municipal Bureau of Economy and Information Technology, Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Municipal Health Commission, Municipal Drug Administration, Municipal Medical Insurance Bureau, Municipal Bureau of Traditional Chinese Medicine, Beijing Customs, Haidian District, Changping District, Daxing District and Economic Development District respectively promote according to their responsibilities)
(6) The implementation of the list to create a safe and stable biomedical industry chain supply chain in accordance with the "demand-oriented, systematic planning.，企业主体、政府统筹，龙头牵引、联合创新”的原则，依托中关村示范区高精尖产业强链工程，梳理生物医药产业的核心技术和“卡脖子”关键节点，由领军企业作为发榜企业提出技术攻关需求，面向全国征集揭榜单位。After reaching the intention of cooperation, the issuing enterprises and the unveiling units set up an innovation consortium, and the issuing enterprises provide research and development funds and necessary research and development testing conditions, jointly carry out technical research and strive to break through the development bottleneck。Highlight the role of end users, clarify the amount of funding for list tasks, optimize the way of scientific research funding support, and support the core technology research of the biomedical industry。
(Municipal departments: Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Municipal Economic and Information Technology Bureau, Municipal Finance Bureau, Haidian District, Changping District, Daxing District and Economic Development District respectively according to their responsibilities)
（七）合理调整创新医疗项目价格的管理机制
We will explore and improve charging policies for medical services such as cell therapy and artificial intelligence assistance, and explore sandbox pilot projects for price management of artificial intelligence products。Innovative medical devices included in the city's "Zhongguancun Innovative medical device Product catalog"，价格确定实施“两同步、动态调”机制，同步立项定价，同步考虑纳入医疗保险和商业保险，边试行、边监测；动态平衡患者、医疗机构、企业利益，探索完善创新技术价格形成机制，逐步优化创新技术价格管理方式，运用价格杠杆鼓励创新技术成果转化、落地。
(Involved ministries and commissions: National Medical Insurance Administration, National Health Commission;Municipal departments: Municipal Medical Insurance Bureau and Municipal Health Commission respectively promote according to their duties)
（八）加强创新技术和产品应用
Actively strive for The State Council to authorize the Beijing Municipal People's Government to examine and approve the import of a small amount of medicinal devices by medical institutions in this city due to clinical urgent need, and the imported medicinal devices shall be used in designated medical institutions for specific medical purposes。Actively strive for the support of the National Health Commission, allowing enterprises registered in the China (Beijing) Pilot Free Trade Zone to complete Phase I-III clinical trials in China and obtain marketing authorization for innovative drugs, "along with the batch" in designated medical institutions, no additional market access requirements。Establish a green channel, win the support of the State Medical Insurance Bureau, do a good job in the early stage of communication, guide biomedical enterprises to do a good job in medical insurance negotiations, and improve the success rate of innovative drugs in the city into the medical insurance drug list。To study and formulate relevant policies and measures, strengthen publicity and promotion, and timely and more include innovative pharmaceutical devices in the scope of government procurement and promotion and application。
(State Council;Ministries and commissions involved: National Health Commission, State Food and Drug Administration;Municipal departments: Municipal Health Commission, Municipal Medical Insurance Bureau, Municipal Food and Drug Administration respectively according to their responsibilities)
（九）丰富商业健康险产品供给
We will improve the multi-tiered medical security system, encourage commercial insurance institutions to set up commercial supplementary health insurance, and include compliant self-funded medical devices that are not covered by the medical insurance list and are necessary for treatment in the reimbursement scope。Dynamic adjustment of commercial health insurance to support the list of medical equipment, the city's enterprises to innovate medical equipment commercial insurance support and encouragement。
(Municipal departments: Municipal Medical Insurance Bureau, Municipal Financial Supervision Bureau, Beijing Banking and Insurance Regulatory Bureau respectively according to their responsibilities)
（十）进一步释放创新和市场活力
Explore a new model of co-construction and sharing of health and medical data, and further strengthen the standardization of clinical and medical data and the open communication between hospitals。We will continue to support the standardized and healthy development of social medical institutions, and implement a recording system for the allocation of Class B large medical equipment to social medical institutions in the China (Beijing) Pilot Free Trade Zone。To support the municipal pilot construction of electronic prescription center, to provide third-party information services for prescription drug sales institutions, except for special management drugs, all domestic listed prescription drugs are allowed to rely on electronic prescription for Internet sales。优化本市药品经营企业准入标准，进一步释放市场活力。Optimize the management measures of preparation dispensing and use in medical institutions to further meet the needs of clinical drugs。
(Involved ministries and commissions: Ministry of Commerce, National Health Commission, State Medical Insurance Administration, State Food and Drug Administration;Municipal departments: Municipal Health Commission, Municipal Bureau of Commerce, Municipal Medical Insurance Bureau, Municipal Economic and Information Bureau, Municipal Drug Administration, and Municipal Bureau of Traditional Chinese Medicine respectively promote according to their responsibilities)
（十一）加强国际合作加快产品和技术进出口
Strengthen international exchanges and cooperation in drug supervision, take key products and key areas as breakthroughs, actively explore mutual recognition of supervision, and improve the level of internationalization of supervision。Support the city's national TCM service export base and key institutions of TCM service trade to explore the international market, and build an international comprehensive service platform for TCM health and wellness。Through the establishment of export tax rebate "capital pool" and other means to accelerate the export of biopharmaceutical products and technologies that have been approved in this city。Build a biomedical International sales (CSO) platform, cooperate with international sales promotion agencies, and bring innovative products and technologies to the international market。To carry out the docking of the city's bio-pharmaceutical park and foreign parks, and establish and expand trade and investment between them。
(Involved ministries and commissions: State Administration of Traditional Chinese Medicine;Municipal departments: Municipal Bureau of Commerce, Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Municipal Bureau of Economy and Information Technology, Municipal Drug Administration, Municipal Bureau of Traditional Chinese Medicine, Beijing Customs, Haidian District, Changping District, Daxing District, Jingkai District, Dongcheng District, Xicheng District and Chaoyang District respectively according to their responsibilities)
（十二）加强知识产权保护
In combination with the characteristics of the biomedical industry, the layout of intellectual property public service workstations will be improved to provide well-targeted and convenient intellectual property public services。组建医药健康领域知识产权联盟，构筑产业领域专利池。建立知识产权纠纷多元化解决与快速维权机制。Explore the establishment of a fair intellectual property evaluation mechanism, optimize intellectual property pledge registration services, and improve the risk sharing mechanism and the disposal mechanism of intellectual property pledge financing。
(Municipal departments: Municipal Intellectual Property Office and Municipal Food and Drug Administration respectively promote according to their duties)
（十三）支持建立生物医药人才项目离岸基地
Using multi-point layout and multi-mode, to achieve a one-point (Beijing base) to multi-point (global base) talent dialogue and technical exchange。以离岸基地为核心，建立与世界接轨的柔性引才机制。We will use market-oriented means to provide overseas talents in the field of biomedicine with a carrier registered in Beijing and operated at home and abroad, and promote the concentration of overseas high-quality innovation resources through overseas pre-incubation。Establish a comprehensive service mechanism for the landing of offshore projects, and provide full agency services and project incubation services for overseas talents in Beijing's offshore innovation and entrepreneurship。
(Involved ministries and commissions: China Association for Science and Technology;Municipal departments: Municipal Association for Science and Technology, Municipal Bureau of Talent Work, Haidian District, Changping District, Daxing District, economic development District respectively according to their responsibilities)
（十四）加大资金支持力度
Support key areas to set up government-led industry guidance special funds, and give full play to the role of small and medium-sized enterprise development fund, high-tech fund, science and technology fund and other sub-funds under the municipal government investment guidance fund, to support the development of the biomedical industry。We will actively expand financing channels and support qualified biomedical enterprises to go public for financing and issue corporate credit bonds。Encourage social capital to initiate the establishment of biomedical industry investment funds, and increase long-term investment。Encourage financing guarantee institutions to increase the guarantee of bank loans to smes in the field of biomedicine。Support credit service institutions to improve the collection and processing capacity of credit information in the biomedical industry, encourage financial institutions to innovate financial products, and support the innovative development of biomedicine。
(Municipal departments: Municipal Finance Bureau, Municipal Financial Supervision Bureau, Beijing Banking and Insurance Regulatory Bureau, Beijing Securities Regulatory Bureau, Municipal Economic and Information Technology Bureau, Municipal Science and Technology Commission, Zhongguancun Administrative Committee, Haidian District, Changping District, Daxing District, Economic Development District respectively according to their responsibilities)
（十五）建立健全区域合作发展利益分享机制
We will support all districts in determining a benefit-sharing mechanism for cross-regional cooperation projects through consultation in accordance with the law, guide the rational distribution of projects and industries, and promote coordinated regional development。Due to the needs of regional cooperation and development, enterprises that migrate across districts within the city and "register in one district and operate in multiple points" shall reasonably distribute financial and tax benefits in accordance with the unified policy of the city, form a new pattern of resource interoperability and coordinated development as soon as possible, and promote the overall improvement of the biomedical industry。
(Municipal departments: Municipal Finance Bureau, Beijing Taxation Bureau, Haidian District, Changping District, Daxing District, economic development District respectively according to their responsibilities)
（十六）全面加强审评审批和检验能力建设
Establish a review, approval and inspection system that is compatible with the leapfrog development of the city's biomedical industry。Actively introduce senior professionals with international regulatory experience and familiar with the reality of Chinese industry。Accelerate the construction of an inspector team system that effectively meets the needs of drug supervision, strengthen the strength of inspectors in drug inspection institutions, and strengthen inspection work。Establish a collaborative mechanism for research and review of technological innovative products, advance the intervention of technical review forces, synchronously carry out supporting review technology research, and improve the speed of innovative pharmaceutical devices to market。Standard international first-class drugs, pharmaceutical packaging materials, medical devices, cosmetics inspection and testing technology, optimize supporting facilities, accelerate the expansion of inspection capabilities, and comprehensively improve the city's inspection and testing capabilities。
（市级部门：市药监局）
(17) Establish and improve the fault-tolerant mechanism for institutional innovation in the China (Beijing) Pilot Free Trade Zone
坚持“三个区分开来”，鼓励大胆试、大胆闯，对在改革创新、担当作为中出现失误错误的干部，It should be combined with motivation, objective conditions, procedures and methods, nature and degree, consequences and loss recovery，依规依纪依法免予追究责任或从轻、减轻追究责任。Adhere to the combination of fault tolerance and error correction, on the basis of fault tolerance, adhere to the principle that mistakes must be corrected and mistakes must be corrected。
(Municipal departments: Organization Department of the Municipal Party Committee, Municipal Commission for Discipline Inspection and Municipal Supervisory Commission respectively promote according to their duties)
三、组织实施
All districts and relevant departments should raise their awareness and introduce special support policies to promote the open development of biomedicine in key areas such as investment, trade transactions, finance, taxation and finance, customs clearance facilitation, safety supervision and resource factor guarantee。The city's "two district" office should strengthen coordination, and the national affairs involved in the program should be promoted jointly from the municipal planning and departments, and strive to land the first trial policy as soon as possible, while strengthening the tracking and analysis of the implementation of the program and establishing a timetable for work promotion。In principle, only reform measures involving municipal powers will be implemented before December 31, 2022, and reform measures involving national powers will be implemented after approval according to procedures。 |
