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    Home > Medical News > Latest Medical News > Beijing biomedical whole industry chain open in the first half of the year approved innovative drugs and other national first

    Beijing biomedical whole industry chain open in the first half of the year approved innovative drugs and other national first

    • Last Update: 2022-09-20
    • Source: Internet
    • Author: User
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    The "Implementation Plan for the Opening Up of the Whole Industry Chain of Biomedicine in Beijing" released at the beginning of this year put forward 17 50 policy measures and suggestions to accelerate the aggregation and facilitation of innovation elements, build new mechanisms, explore new practices, and help new opening up
    .
    As of now, 38 of the 50 measures have been completed, with a completion rate of 76%.
    In the first half of this year, 17 innovative drugs and medical device products were approved in Beijing, ranking first
    in the country.
     
    The relevant person in charge of the Beijing Municipal Food and Drug Administration said at a press conference held today that the "Plan" is the first implementation plan for the opening of the whole industry chain introduced for the construction of Beijing's "two districts", which not only provides policy support for the leapfrog development of Beijing's biomedical industry, but also provides useful exploration
    for the development of the national pilot free trade zone and the reform and opening up of the national biomedical industry 。 After the formulation and release of the "Plan", the Beijing Municipal Food and Drug Administration led a special class of biomedical work composed of 18 municipal departments and 8 districts, facing the blockages, difficulties and pain points of the industrial chain, focusing on the supply of raw materials at the front end of the industrial chain, the use of clinical resources at the middle end of the industrial chain, the acceleration of product approval, the transformation of achievements at the end of the industrial chain, clinical application and other issues, and formulated solutions to achieve small incisions, practical measures and quick
    results.
     
    The person in charge said that the "Plan" is problem-oriented, puts forward 17 50 policy measures and suggestions, accelerates the aggregation and facilitation of innovation elements, builds new mechanisms, explores new practices, and helps new opening up
    .
    As of now, 38 of the 50 measures have been completed, with a completion rate of 76%.
    6 of the 13 matters that require the authorization and consent of the relevant state departments have been implemented; 37 policy measures involving the municipality's powers, 32 have been completed
    .
     
    First and foremost, we will promote the implementation of a number of national initiatives and exemplary measures
     
    Beijing has actively given full play to the advantages of the capital's resources, taken the lead in breaking through the existing approval and management methods nationwide, and opened the door to
    the industry.
    For example, with the support of the Ministry of Science and Technology, the third-party human genetic resources preservation platform has been approved, and the vitality of scientific and technological innovation in multi-party cooperation between industry, research and medicine has been continuously enhanced
    .
    With the support of the General Administration of Customs, Beijing adopts a new regulatory model of one-pass approval and multi-site clinical trials for the quarantine of humanized cells for clinical trial use, which further simplifies the customs entry procedures for humanized cells and realizes intensive and efficient supervision
    .
    Under the support and guidance of the State Food and Drug Administration, the Beijing Pharmaceutical and Medical Device Innovation Service Station has provided services to enterprises, and in the first half of this year alone, 17 innovative drugs and medical device products in Beijing have been approved, ranking first
    in the country.
     
    Classification breakthroughs accelerate the implementation of institutional innovation and reform measures
     
    Beijing has focused on the pilot project of establishing a "white list" system for the import of R&D articles for biomedical enterprises to fundamentally solve the bottleneck problem of import of R&D articles
    .
    At the same time, focusing on the implementation effect of the policy, the formulation of the program and the project reserve are promoted simultaneously, the pilot program was introduced on June 20, and the first batch of "white lists" was released
    on June 28.
    The "white list" has opened up a key blockage in the research and development process and boosted the process
    of new drug creation and research.
     
    In order to explore a new model of health and medical data co-construction and sharing, Beijing further strengthens the standardization of clinical medical data and the open interconnection between hospitals, and creates 16 key application scenarios
    in four categories, including serving individual residents, serving medical institutions, serving the development of service industries, and serving urban operation.
     
    Focusing on continuing to support the healthy development of social medical standards, Beijing implements a filing system for the allocation of Class B large-scale medical equipment in social medical institutions in the free trade zone, formulates and introduces the implementation rules for the filing management of class B large-scale medical equipment in the free trade pilot zone, and fully implements a notification commitment system
    for social medical treatment within the scope of indicators.
    Focusing on the establishment of a review and approval and inspection system that is compatible with the leapfrog development of the biomedical industry in Beijing, we will build a "two products and one device" inspection and testing system, and accelerate the construction of the country's first vaccine testing center project
    .
     
    Promote "extended chain, supplementary chain, and strong chain" to increase support for key projects
     
    Focusing on the promotion of "extended chain, supplementary chain, and strong chain", Daxing District is led by the district as the "chain chief" of the biomedical industry chain, and continues to promote the clinical application of innovative products such as innovative drugs and medical devices in biomedical bases; In view of the traditional industry transformation and upgrading demonstration zone, specific opinions and measures have been issued to upgrade the existing biomedical industry base, linkong area and Daxing economic development zone, and there have been successful cases
    .
     
    Haidian District focuses on key directions such as vaccines, cell gene therapy, and high-end medical devices, and promotes the layout of the underlying technology of medicine and health; In-depth layout of a number of cutting-edge technology service platforms such as AI biocomputing, protein design, gene editing, and large molecule drug CDMO platform; Promote the construction of R&D outsourcing service platforms such as chemical drug CRO and clinical platforms, Shangdi Biomedical Park and medical robot CDMO; Through the establishment of biomedical funds, the release of reform measures such as "unveiling the commander-in-chief" and the procurement of leading enterprises, we will continue to increase support and landing services for key projects
    .
     
    Beijing Economic and Technological Development Zone strengthens the cultivation of industrial ecology and the supply of innovation elements, takes the lead in building a "concept verification platform - public technical service platform - proofing center - pilot base" biomedical industry full-link service system, opens up the channel of production, study and research, and promotes the rapid transformation of technological innovation, and has gathered more than 1,700 biomedical enterprises of various types to form a complete industrial chain
    covering biomedicine, medical devices, health industry and other fields.
     
    Changping District focused on building a 100-billion-level pharmaceutical and health industry cluster, issued the "Action Plan for Doubling the Development of the Pharmaceutical and Health Industry (2022-2025)", introduced the city's first free trade group pharmaceutical and health industry promotion policy, and landed 4 national first cases such as decentralized clinical trials and cell and gene therapy innovation centers; Focus on cutting-edge fields, and introduce a number of international professional operation teams such as Tsinghua Institute of Industry and Research and Darts; Promote the construction of Gaobo Hospital, the country's first international research hospital; A number of landmark projects such as Nuocheng Jianhua Innovative Drug Production Base and Kexing Biological High-tech Industrial Transformation Base have been launched, and more than 60 well-known scientists have set up enterprises to settle down
    .
     
    The person in charge said that the implementation of the "Plan" has achieved remarkable results
    .
    In the next step, the biomedical special class will coordinate various departments and enterprises, go deep into the park and enterprises, send policies and services, improve the clarity of policies, standards and norms, continue to promote the innovation of the biomedical industry system and the opening up of the industrial chain, and strive to create a "Beijing model"
    for the development of the national pilot free trade zone and the reform and opening up of the national biomedical industry.
    (End)
    The "Implementation Plan for the Opening Up of the Whole Industry Chain of Biomedicine in Beijing" released at the beginning of this year put forward 17 50 policy measures and suggestions to accelerate the aggregation and facilitation of innovation elements, build new mechanisms, explore new practices, and help new opening up
    .
    As of now, 38 of the 50 measures have been completed, with a completion rate of 76%.

    In the first half of this year, 17 innovative drugs and medical device products were approved in Beijing, ranking first
    in the country.
     
    The relevant person in charge of the Beijing Municipal Food and Drug Administration said at a press conference held today that the "Plan" is the first implementation plan for the opening of the whole industry chain introduced for the construction of Beijing's "two districts", which not only provides policy support for the leapfrog development of Beijing's biomedical industry, but also provides useful exploration
    for the development of the national pilot free trade zone and the reform and opening up of the national biomedical industry 。 After the formulation and release of the "Plan", the Beijing Municipal Food and Drug Administration led a special class of biomedical work composed of 18 municipal departments and 8 districts, facing the blockages, difficulties and pain points of the industrial chain, focusing on the supply of raw materials at the front end of the industrial chain, the use of clinical resources at the middle end of the industrial chain, the acceleration of product approval, the transformation of achievements at the end of the industrial chain, clinical application and other issues, and formulated solutions to achieve small incisions, practical measures and quick
    results.
     
    The person in charge said that the "Plan" is problem-oriented, puts forward 17 50 policy measures and suggestions, accelerates the aggregation and facilitation of innovation elements, builds new mechanisms, explores new practices, and helps new opening up
    .
    As of now, 38 of the 50 measures have been completed, with a completion rate of 76%.

    6 of the 13 matters that require the authorization and consent of the relevant state departments have been implemented; 37 policy measures involving the municipality's powers, 32 have been completed
    .
     
    First and foremost, we will promote the implementation of a number of national initiatives and exemplary measures
    First and foremost, we will promote the implementation of a number of national initiatives and exemplary measures
     
    Beijing has actively given full play to the advantages of the capital's resources, taken the lead in breaking through the existing approval and management methods nationwide, and opened the door to
    the industry.
    For example, with the support of the Ministry of Science and Technology, the third-party human genetic resources preservation platform has been approved, and the vitality of scientific and technological innovation in multi-party cooperation between industry, research and medicine has been continuously enhanced
    .
    With the support of the General Administration of Customs, Beijing adopts a new regulatory model of one-pass approval and multi-site clinical trials for the quarantine of humanized cells for clinical trial use, which further simplifies the customs entry procedures for humanized cells and realizes intensive and efficient supervision
    .
    Under the support and guidance of the State Food and Drug Administration, the Beijing Pharmaceutical and Medical Device Innovation Service Station has provided services to enterprises, and in the first half of this year alone, 17 innovative drugs and medical device products in Beijing have been approved, ranking first
    in the country.
    Pharmaceuticals
     
    Classification breakthroughs accelerate the implementation of institutional innovation and reform measures
    Classification breakthroughs accelerate the implementation of institutional innovation and reform measures
     
    Beijing has focused on the pilot project of establishing a "white list" system for the import of R&D articles for biomedical enterprises to fundamentally solve the bottleneck problem of import of R&D articles
    .
    At the same time, focusing on the implementation effect of the policy, the formulation of the program and the project reserve are promoted simultaneously, the pilot program was introduced on June 20, and the first batch of "white lists" was released
    on June 28.
    The "white list" has opened up a key blockage in the research and development process and boosted the process
    of new drug creation and research.
    Medicine
     
    In order to explore a new model of health and medical data co-construction and sharing, Beijing further strengthens the standardization of clinical medical data and the open interconnection between hospitals, and creates 16 key application scenarios
    in four categories, including serving individual residents, serving medical institutions, serving the development of service industries, and serving urban operation.
     
    Focusing on continuing to support the healthy development of social medical standards, Beijing implements a filing system for the allocation of Class B large-scale medical equipment in social medical institutions in the free trade zone, formulates and introduces the implementation rules for the filing management of class B large-scale medical equipment in the free trade pilot zone, and fully implements a notification commitment system
    for social medical treatment within the scope of indicators.
    Focusing on the establishment of a review and approval and inspection system that is compatible with the leapfrog development of the biomedical industry in Beijing, we will build a "two products and one device" inspection and testing system, and accelerate the construction of the country's first vaccine testing center project
    .
     
    Promote "extended chain, supplementary chain, and strong chain" to increase support for key projects
    Promote "extended chain, supplementary chain, and strong chain" to increase support for key projects
     
    Focusing on the promotion of "extended chain, supplementary chain, and strong chain", Daxing District is led by the district as the "chain chief" of the biomedical industry chain, and continues to promote the clinical application of innovative products such as innovative drugs and medical devices in biomedical bases; In view of the traditional industry transformation and upgrading demonstration zone, specific opinions and measures have been issued to upgrade the existing biomedical industry base, linkong area and Daxing economic development zone, and there have been successful cases
    .
    Medical devices Medical devices
     
    Haidian District focuses on key directions such as vaccines, cell gene therapy, and high-end medical devices, and promotes the layout of the underlying technology of medicine and health; In-depth layout of a number of cutting-edge technology service platforms such as AI biocomputing, protein design, gene editing, and large molecule drug CDMO platform; Promote the construction of R&D outsourcing service platforms such as chemical drug CRO and clinical platforms, Shangdi Biomedical Park and medical robot CDMO; Through the establishment of biomedical funds, the release of reform measures such as "unveiling the commander-in-chief" and the procurement of leading enterprises, we will continue to increase support and landing services for key projects
    .
    Enterprise enterprise
     
    Beijing Economic and Technological Development Zone strengthens the cultivation of industrial ecology and the supply of innovation elements, takes the lead in building a "concept verification platform - public technical service platform - proofing center - pilot base" biomedical industry full-link service system, opens up the channel of production, study and research, and promotes the rapid transformation of technological innovation, and has gathered more than 1,700 biomedical enterprises of various types to form a complete industrial chain
    covering biomedicine, medical devices, health industry and other fields.
     
    Changping District focused on building a 100-billion-level pharmaceutical and health industry cluster, issued the "Action Plan for Doubling the Development of the Pharmaceutical and Health Industry (2022-2025)", introduced the city's first free trade group pharmaceutical and health industry promotion policy, and landed 4 national first cases such as decentralized clinical trials and cell and gene therapy innovation centers; Focus on cutting-edge fields, and introduce a number of international professional operation teams such as Tsinghua Institute of Industry and Research and Darts; Promote the construction of Gaobo Hospital, the country's first international research hospital; A number of landmark projects such as Nuocheng Jianhua Innovative Drug Production Base and Kexing Biological High-tech Industrial Transformation Base have been launched, and more than 60 well-known scientists have set up enterprises to settle down
    .
    Hospital Hospital
     
    The person in charge said that the implementation of the "Plan" has achieved remarkable results
    .
    In the next step, the biomedical special class will coordinate various departments and enterprises, go deep into the park and enterprises, send policies and services, improve the clarity of policies, standards and norms, continue to promote the innovation of the biomedical industry system and the opening up of the industrial chain, and strive to create a "Beijing model"
    for the development of the national pilot free trade zone and the reform and opening up of the national biomedical industry.
    (End)
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