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    Home > Active Ingredient News > Infection > The Biosecurity Act was formally considered and adopted on how human genetic resources are provided for

    The Biosecurity Act was formally considered and adopted on how human genetic resources are provided for

    • Last Update: 2020-11-05
    • Source: Internet
    • Author: User
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    On October 17, 2020, the Biosecurity Law of the People's Republic of China was adopted by the 22nd Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China.
    The law is clearly defined( (1) prevention and control of major new outbreaks of infectious diseases, animals and plants; (2) biotechnology research, development and application; (3) biosecurity management of pathogenic microbial laboratories; (4) the safe management of human genetic resources and biological resources; (5) prevention of invasive alien species and protection of biodiversity; (6) response to microbial resistance; (vii) prevention of biological terrorist attacks and the threat of biological weapons; and (vii) the application of this law to other activities related to biological security.
    The Central Leading Body for National Security is responsible for the decision-making and coordination of national biosecurity work, studies and guides the formulation and implementation of national biosethics strategies and related major policies and guidelines, coordinates major national biosecurity matters and important work, and establishes coordination mechanisms for national biosecurity work.
    The coordination mechanism for national biosecurity work is composed of competent departments and relevant military organs such as health and health, agriculture and rural areas, science and technology, and foreign affairs under the State Council, which analyzes and studies the national biosecurity situation, and organizes and coordinates and urges the promotion of national biosecurity-related work.
    offices of the National Biosecurity Coordination Mechanism, which is responsible for the day-to-day work of the Coordination Mechanism.
    committee of experts for the coordination mechanism of national bios security work to provide decision-making advice on the research, policy formulation and implementation of national biosethics strategies.
    to establish a unified national bios security information platform organized by the National Biosecurity Coordination Mechanism, relevant departments shall transfer bios security data, data and other information to the national biosecurity information platform to achieve information sharing.
    establish biosecurity directory and inventory systems in the united States.
    The State Council and its relevant departments shall, in accordance with the needs of biosecurity work, formulate, publish or make lists of materials, equipment, technologies, activities, important biological resources data, infectious diseases, animal and plant diseases, invasive alien species, etc., and make dynamic adjustments.
    establish biosecurity review systems in other countries.
    major biological matters and activities affecting or likely to affect national security, the relevant departments of the State Council shall conduct biosecurity reviews to effectively prevent and defuse biosecurity risks.
    On the safe management of human genetic resources and biological resources of general concern: Article 56 of the Law stipulates that: the following activities shall be approved by the competent department of science and technology under the State Council: (1) collecting important genetic family systems in China, human genetic resources in specific areas or collecting human genetic resources of the type and quantity prescribed by the competent department of science and technology under the State Council;
    the provisions of the foremost paragraph do not include the collection, preservation and related activities of human genetic resources for the purposes of clinical diagnosis and treatment, blood collection services, investigation and prosecution of illegal crimes, doping testing and funeral.
    In order to obtain the relevant drugs and medical devices to be licensed for listing in China, international cooperation in clinical trial institutions using human genetic resources in China for international clinical trials without involving human genetic resources leaving the country does not require approval;
    foreign organizations, individuals and institutions established or actually controlled by them shall not collect or preserve human genetic resources in Our country, and may not provide human genetic resources of our country abroad.
    At the same time, Articles 57, 58 and 59 stipulate that if information on human genetic resources in China is provided or opened for use to overseas organizations, individuals and institutions established or actually controlled by them, the competent department of science and technology under the State Council shall report in advance and submit a backup of the information.
    the acquisition and utilization of China's biological resources by foreign organizations, individuals and institutions established or under their actual control shall be approved in accordance with the law.
    international scientific research cooperation through the use of China's human genetic and biological resources, Chinese units and their researchers shall participate in the whole process and substantively in the research and share relevant rights and interests in accordance with the law.
    The Biosecurity Law of the People's Republic of China will come into effect on April 15, 2021.
    The Biosecurity Law of the People's Republic of China (adopted at the 22nd Session of the Standing Committee of the 13th National People's Congress on October 17, 2020) Directory Chapter I General Rules Chapter III Biosecurity Risk Prevention and Control System Chapter III Prevention and Control of Major New Outbreaks of Infectious Diseases, Animal and Plant Outbreaks Chapter IV Biotechnology Research, Development and Application Safety Chapter V Biosecurity of Pathogen Microbiology Laboratory Chapter VI Human Genetic Resources and Biological Resources Security Chapter VII Prevention of Bioterrority and Biological Weapons Threat Chapter VII Chapter VII Building of Biosecurity Capacity-building Chapter 9 Legal Responsibility Chapter 10 Chapter I General Provisions Chapter 1 This Law is enacted in order to safeguard national security, prevent and respond to biosecurity risks, safeguard people's lives and health, protect biological resources and ecological environment, promote the healthy development of biotechnology, promote the building of a community of human destiny, and achieve harmonious coexistence between man and nature. article
    The term "biosecurity" as used in this Law refers to the effective prevention and response of the State to the threat of dangerous biological factors and related factors, the steady and healthy development of biotechnology, the relative absence of danger and threat to people's life and health and ecosystems, and the ability of the biological field to safeguard national security and sustainable development.
    This Law shall apply to the following activities: (1) prevention and control of major new outbreaks of infectious diseases, animal and plant outbreaks; (ii) biotechnology research, development and application; (iii) biosecurity management of pathogenic microbiological laboratories; (iv) management of the safety of human genetic resources and biological resources; (5) prevention of invasive alien species and protection of biodiversity; (6) response to microbial resistance; (vii) prevention of biological terrorist attacks and threats to biological weapons; and (vii) prevention of biological security-related activities.
    3 Biosecurity is an important part of national security.
    should carry out the overall national security concept, coordinate development and security, and adhere to the principles of people-oriented, risk prevention, classification management and coordination.
    . Article 4 Adhere to the leadership of the Communist Party of China in the work of national biosecurity, establish and improve the national biosecurity leadership system, strengthen the construction of the national biosecurity risk prevention and control and governance system, and improve the national biosecurity governance capacity.
    Article 5 The State encourages scientific and technological innovation in biotechnology, strengthens the construction of biosecurity infrastructure and the construction of biotech personnel, supports the development of the bio-industry, and promotes the level of biotechnology and enhances biosecurity capabilities through innovation.
    Article 6 The State shall strengthen international cooperation in the field of biosethics, fulfill its obligations under international treaties concluded or participated in by the People's Republic of China, support participation in biotechnology exchanges and cooperation and international rescue of biosethics events, actively participate in the research and formulation of international rules on biosecurity, and promote the improvement of global biosethics governance. article
    People's governments at all levels and their relevant departments shall strengthen the publicity and popularization of bios security laws and regulations and biosecurity knowledge, guide grass-roots mass self-government organizations and social organizations to carry out publicity on biosecurity laws and regulations and biosecurity knowledge, and promote the promotion of biosecurity awareness through the whole society.
    relevant scientific research institutions, medical institutions and other enterprises and institutions shall incorporate biosecurity laws and regulations and biosecurity knowledge into the contents of education and training, and strengthen the cultivation of biosecurity awareness and ethical awareness among students and practitioners.
    news media shall carry out publicity on biosecurity laws and regulations and biosecurity knowledge, supervise public opinion on biosecurity violations, and enhance the public's sense of social responsibility to maintain biosecurity.
    Article 8 No unit or individual may endanger biological safety.
    any unit or individual shall have the right to report acts endangering biosecurity;
    9 the people's governments at or above the county level and their relevant departments shall be recognized and rewarded in accordance with the provisions of the State for units and individuals who have made outstanding contributions to biosecurity work.
    Chapter II Biosecurity Risk Prevention and Control System Article 10 The Central Leading Body for National Security shall be responsible for the decision-making and coordination of national biosecurity work, study and formulate and guide the formulation and implementation of the National Biosecurity Strategy and related major policies and guidelines, coordinate and coordinate major matters and important work of national biosecurity, and establish a coordination mechanism for national biosecurity work.
    , autonomous regions and municipalities directly under the Central Government to establish a coordination mechanism for biosecurity work, organize, coordinate and urge the promotion of biosecurity-related work in their administrative areas.
    Article 11 The coordination mechanism for national biosecurity work shall be composed of competent departments of health and health, agriculture, rural agriculture, science and technology, foreign affairs and other relevant military organs under the State Council, which shall analyze and study the situation of national biosecurity and organize and coordinate and urge the promotion of national biosecurity-related work.
    offices of the National Biosecurity Coordination Mechanism, which is responsible for the day-to-day work of the Coordination Mechanism.
    member units of the National Biosecurity Coordination Mechanism and other relevant departments of the State Council shall be responsible for biosecurity-related work in accordance with the division of responsibilities.
    12, the National Coordinating Mechanism for Biosecurity shall establish an expert committee to provide decision-making advice on the research, policy formulation and implementation of the National Biosecurity Strategy.
    the relevant departments of the State Council to organize the establishment of relevant fields, industries, biosecurity technical advisory expert committee, for biosecurity work to provide advice, evaluation, demonstration and other technical support.
    people's governments at all levels shall be responsible for the work of biosecurity within their administrative areas.
    local people's governments at or above the county level shall be responsible for biosecurity-related work in accordance with the division of responsibilities.
    grass-roots mass self-government organizations shall assist local people's governments and relevant departments to do a good job in the prevention and control of biosecurity risks, emergency disposal and publicity and education.
    units and individuals concerned shall cooperate in the prevention and control of biosecurity risks and emergency disposal.
    Article 14 The State shall establish a system for monitoring and early warning of biosecurity risks.
    the National Biosecurity Coordination Mechanism to establish a national bios security risk monitoring and early warning system to improve biosecurity risk identification and analysis capabilities.
    Article 15 The State shall establish a biosecurity risk investigation and assessment system.
    coordination mechanism for national bios security work shall organize and conduct biosecurity risk investigation and assessment on a regular basis on the basis of data, information and other information on risk monitoring.
    If one of the following circumstances occurs, the relevant departments shall promptly carry out a biosecurity risk investigation and assessment and take the necessary risk prevention and control measures in accordance with the law: (1) detect the possibility of biosecurity risks through risk monitoring or receiving reports;
    Article 16 The State shall establish a system for sharing biosethic information.
    to establish a unified national bios security information platform organized by the National Biosecurity Coordination Mechanism, relevant departments shall transfer bios security data, data and other information to the national biosecurity information platform to achieve information sharing.
    Article 17 The State shall establish a system for the publication of biosethic information.
    Major biosecurity information, such as the overall situation of national biosecurity, warning information on major biosecurity risks, major biosathic events and information on their investigation and processing, shall be issued by the member units of the National Biosecurity Coordination Mechanism in accordance with the division of responsibilities;
    units and individuals shall not fabricate or disseminate false biosecurity information.
    Article 18 The State establishes a system of biosecurity directories and lists.
    The State Council and its relevant departments shall, in accordance with the needs of biosecurity work, formulate, publish or make lists of materials, equipment, technologies, activities, important biological resources data, infectious diseases, animal and plant diseases, invasive alien species, etc., and make dynamic adjustments.
    Article 19 The State shall establish a system of biosecurity standards.
    department in charge of standardization under the State Council and other relevant departments under the State Council shall formulate and improve relevant standards in the field of biosecurity in accordance with the division of responsibilities.
    the relevant departments of the National Biosecurity Coordination Mechanism to strengthen the coordination and convergence of biosecurity standards in different fields, and establish and improve biosecurity standards systems.
    Article 20 The State shall establish a biosecurity review system.
    major biological matters and activities affecting or likely to affect national security, the relevant departments of the State Council shall conduct biosecurity reviews to effectively prevent and defuse biosecurity risks.
    Article 21 The State shall establish a unified leadership, coordinated, orderly and efficient biosecurity emergency response system.
    relevant departments of the State Council shall organize the formulation of emergency plans for biosecurity incidents in relevant fields and industries, and carry out emergency drills, emergency disposal, emergency rescue and post-mortem recovery in accordance with emergency plans and unified deployment.
    Local people's governments at or above the county level and their relevant departments shall formulate, organize, guide and urge relevant enterprises and institutions to formulate emergency plans for biosaeth incidents, strengthen emergency preparedness, personnel training and emergency drills, and carry out emergency response to biosanthy incidents, emergency rescue and post-mortem recovery.
    Chinese People's Liberation army Chinese armed police force shall, in accordance with the orders of the Central Military Commission, participate in the emergency disposal and emergency rescue work of biosecurity incidents in accordance with the law.
    Article 22 The State shall establish a system for the investigation and traceability of biosethic incidents.
    in the event of a major new outbreak of infectious diseases, animal and plant outbreaks and unexplained biosecurity incidents, the National Biosecurity Coordination Mechanism shall organize an investigation and traceability, determine the nature of the incident, comprehensively assess the impact of the incident, and make suggestions and suggestions.
    Article 23 The State shall establish a national access system for animals and plants, animal and plant products and high-risk biological factors that have entered the country for the first time or resumed after suspension.
    , means of transport, containers, goods, articles, packaging and ballast water discharge from international navigation vessels shall meet the requirements of China's biosecurity management.
    customs shall deal with the biosecurity risks found in entry, exit and transit in accordance with the law.
    persons, means of transport, goods, articles, etc. assessed as high risk of biosecurity shall enter the country from designated border crossings and take strict risk prevention and control measures.
    Article 24 The State shall establish a system for responding to major biosecurity incidents abroad.
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