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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。
I. General requirements
(1) Guiding ideology
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，Adhere to the unity of risk prevention and promotion, and combine the short board with the forged long board，Take the initiative to welcome a new round of industrial transformation，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，Stimulate the vitality of innovation in the biomedical industry，Improve international competitiveness，We will promote high-speed, high-end and high-quality development of the biomedical industry，To build an innovative highland in the biomedical industry with global influence。
(2) Basic principles
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。
(3) Work objectives
Seize the strategic opportunity of "two zones" construction，Focus on solving the key difficulties and bottlenecks of the whole industrial chain，We will give full play to the capital's advantages in resources and its exemplary and leading role，We will advance policy trials in key areas，Accelerate the accumulation of innovation resources，Opening-up measures have been strengthened，Optimize the allocation of production factors，The regulatory mechanism has been significantly improved，The innovation ecosystem is better，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。
Ii. Main measures
1. Expanding market access
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)
(2) Provide convenience for innovative enterprises to carry out international pharmaceutical research and development cooperation
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)
(3) Promoting customs clearance facilitation for R&D goods
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)
(4) Increase support for the R&D registration of innovative pharmaceutical devices
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。We will exercise inclusive and prudent supervision over innovative pharmaceutical devices。To provide convenient services for scientific research institutions and R&D enterprises to purchase drugs for research and development。Establish a unified biomedical policy search platform to strengthen policy navigation and interpretation。
(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)
(5) Establish the "chain length system" of key pipelines
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.。Strengthen top-level design，Coordinate internal and external resources，Coordinate various parks，Continuous intensive cultivation，Establish a full-life cycle service mechanism that closely links research and development, clinical, approval, industrialization, application and promotion，Actively promote "chain extension, chain reinforcement and strong chain"，Build a leading enterprise，We will foster more specialized and innovative small and medium-sized enterprises，Accelerate the construction of a complete industrial chain，We will promote coordinated development of upstream and downstream companies, production, supply and marketing, and large, small and medium-sized enterprises，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.，Enterprise main body, government overall planning，Leading traction, joint innovation "principle，Relying on Zhongguancun demonstration zone high-precision industrial chain project，Sort out the core technologies and key nodes of the biomedical industry，The leading enterprise shall put forward the technical research demand as the issuing enterprise，For the whole country to collect the unveiling unit。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)
(7) Reasonable adjustment of the price management mechanism of innovative medical projects
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"，The "two synchronous, dynamic adjustment" mechanism is implemented in price determination，Simultaneous project pricing，Consider both medical insurance and commercial insurance，Trial, while monitoring;Dynamically balance the interests of patients, medical institutions and enterprises，We will explore and improve the pricing mechanism for innovative technologies，Gradually optimize the price management of innovative technologies，Use price leverage to encourage the transformation and implementation of innovative technological achievements。
(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)
8. Strengthening the application of innovative technologies and products
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)
(9) Enriching the supply of commercial health insurance products
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)
10. Further unleashing innovation and market vitality
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。Optimize the admission standards of pharmaceutical trading enterprises in this city, and further release the vitality of the market。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)
11. Strengthen international cooperation to accelerate the import and export of products and technologies
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)
12. Strengthening intellectual property protection
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。Establish the intellectual property alliance in the field of medicine and health, and build the patent pool in the industrial field。Establish a mechanism for diversified resolution of intellectual property disputes and rapid protection of rights。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)
(13) Support the establishment of offshore bases for biomedical talent projects
Using multi-point layout and multi-mode, to achieve a one-point (Beijing base) to multi-point (global base) talent dialogue and technical exchange。With offshore base as the core, establish a flexible talent attracting mechanism that is in line with the world。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)
14. Increasing financial support
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)
15. Establishing and improving mechanisms for sharing benefits of regional cooperation and development
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)
16. Comprehensively strengthen capacity building for review, approval and inspection
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。
(Municipal Department: Municipal Drug Administration)
(17) Establish and improve the fault-tolerant mechanism for institutional innovation in the China (Beijing) Pilot Free Trade Zone
Adhere to the "three distinctions"，Encourage bold experimentation and daring，To those cadres who have made mistakes in reform, innovation and responsibility，It should be combined with motivation, objective conditions, procedures and methods, nature and degree, consequences and loss recovery，Exemption from liability or leniency or mitigation of liability in accordance with regulations and disciplines。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)
3. Organization and implementation
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。 |
