The People’s Republic of China Biosecurity Law (Adopted at the 22nd Meeting of the Standing Committee of the 13th National People’s Congress on October 17, 2020) Contents Chapter 1 General Provisions Chapter 2 Biosecurity Risk Prevention and Control System Chapter 3 Prevention and Control of Major Newly Emerging and Re-emerging Infectious Diseases and Animal and Plant Epidemics Chapter 4 Biosecurity of Biotechnology Research, Development, and Application Chapter 5 Biosafety of Pathogen Microorganism Laboratories Chapter 6 Security of Human Genetic Resources and Biological Resources Chapter 7 Prevention of Bioterrorism and Biological Weapons Threats Chapter 8 Biosecurity Capacity Building Chapter 9 Legal Liability Chapter 10 Supplementary Provisions Chapter 1 General Provisions Article 1 This Law is enacted to safeguard national security, prevent and respond to biosecurity risks, protect people’s lives and health, protect biological resources and the ecological environment, promote the healthy development of biotechnology, promote the building of a community with a shared future for mankind, and achieve harmonious coexistence between humans and nature. Article 2 The term "biosecurity" as used in this Law refers to the state where a country effectively prevents and responds to threats from dangerous biological factors and related factors, biotechnology can develop steadily and healthily, the health of the people and the ecosystem are relatively safe and free from threats, and the biological field has the ability to maintain national security and sustainable development. The following activities shall be governed by this Law: (1) Prevention and control of major newly emerging and re-emerging infectious diseases and animal and plant epidemics; (2) Research, development, and application of biotechnology; (3) Biosafety management of pathogen microorganism laboratories; (4) Security management of human genetic resources and biological resources; (5) Prevention of alien species invasion and protection of biodiversity; (6) Addressing microbial resistance; (7) Prevention of bioterrorism attacks and defense against biological weapons threats; (8) Other activities related to biosecurity. Article 3 Biosecurity is an important component of national security. In upholding biosecurity, the overall national security outlook should be implemented, development and security should be coordinated, and the principles of people-oriented approach, risk prevention, classified management, and collaborative cooperation should be adhered to. Article 4 Adhere to the leadership of the Communist Party of China over national biosecurity work, 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 bio-technological innovation, strengthens the construction of biosecurity infrastructure and teams of bio-technology talents, supports the development of the bio-industry, and uses innovation to drive the improvement of bio-technology levels and enhance biosecurity capabilities. Article 6 The state strengthens international cooperation in the field of biosecurity, fulfills the obligations stipulated in international treaties concluded or acceded to by the People’s Republic of China, supports and participates in the international exchange and cooperation of bio-technology and international rescue of biosecurity incidents, actively participates in the research and formulation of international biosecurity rules, and promotes the improvement of global biosecurity governance. Article 7 All levels of people’s governments and their relevant departments should strengthen the publicity and popularization of biosecurity laws, regulations, and knowledge, guide grassroots mass autonomous organizations and social organizations to carry out publicity of biosecurity laws, regulations, and knowledge, and promote the improvement of biosecurity awareness throughout society. Relevant scientific research institutions, medical institutions, and other enterprises and institutions should incorporate biosecurity laws, regulations, and knowledge into education and training content, and strengthen the cultivation of biosecurity and ethical awareness among students and employees. News media should carry out public welfare publicity of biosecurity laws, regulations, and knowledge, conduct public opinion supervision of biosecurity violations, and enhance the social responsibility awareness of the public in safeguarding biosecurity. Article 8 No unit or individual may endanger biosecurity. Any unit or individual has the right to report behaviors that endanger biosecurity; departments that receive reports shall deal with them in a timely manner in accordance with the law. Article 9 Units and individuals who make outstanding contributions to biosecurity work shall be commended and rewarded by the people’s governments at or above the county level and their relevant departments in accordance with state regulations. Chapter 2 Biosecurity Risk Prevention and Control System Article 10 The central national security leading institution is responsible for the decision-making and coordination of national biosecurity work, researching and formulating, guiding the implementation of national biosecurity strategies and relevant major policies, coordinating major matters and important work related to national biosecurity, and establishing a national biosecurity work coordination mechanism. Provinces, autonomous regions, and municipalities directly under the Central Government shall establish biosecurity work coordination mechanisms, organize coordination, and supervise and promote relevant biosecurity work within their respective administrative regions. Article 11 The national biosecurity work coordination mechanism shall be composed of the main departments of the State Council in charge of health and health, agriculture and rural areas, science and technology, and foreign affairs, and relevant military organs. It analyzes and assesses the national biosecurity situation, organizes coordination, and supervises and promotes relevant national biosecurity work. The national biosecurity work coordination mechanism shall set up an office to be responsible for the daily work of the coordination mechanism. Member units of the national biosecurity work coordination mechanism and other relevant departments of the State Council shall be responsible for biosecurity-related work according to their respective responsibilities. Article 12 The national biosecurity work coordination mechanism shall establish an expert committee to provide decision-making consultation for national biosecurity strategic research, policy formulation, and implementation. Relevant departments of the State Council shall organize the establishment of biosecurity technical consulting expert committees in relevant fields and industries to provide consulting, evaluation, and demonstration technical support for biosecurity work. Article 13 Local people’s governments at all levels are responsible for biosecurity work within their respective administrative regions. Relevant departments of the people’s governments at or above the county level shall be responsible for biosecurity-related work according to their respective responsibilities. Grassroots mass autonomous organizations should assist local people’s governments and relevant departments in carrying out biosecurity risk prevention and control, emergency response, and publicity and education. Relevant units and individuals should cooperate in carrying out biosecurity risk prevention and control and emergency response. Article 14 The state shall establish a biosecurity risk monitoring and early warning system. The national biosecurity work coordination mechanism shall organize the establishment of a national biosecurity risk monitoring and early warning system to improve the ability to identify and analyze biosecurity risks. Article 15 The state shall establish a biosecurity risk investigation and assessment system. The national biosecurity work coordination mechanism shall regularly organize biosecurity risk investigations and assessments based on risk monitoring data, information, etc. In any of the following circumstances, relevant departments shall promptly conduct biosecurity risk investigations and assessments and take necessary risk prevention and control measures in accordance with the law: (1) Biosecurity risks may exist through risk monitoring or reported incidents; (2) To determine the key areas and projects for supervision and management, formulate and adjust relevant biosecurity catalogues or lists; (3) Major newly emerging and re-emerging infectious diseases, animal and plant epidemics, and other events that endanger biosecurity occur; (4) Other circumstances that require investigation and assessment. Article 16 The state shall establish a biosecurity information sharing system. The national biosecurity work coordination mechanism shall organize the establishment of a unified national biosecurity information platform, and relevant departments shall submit biosecurity data, information, etc. to the national biosecurity information platform to achieve information sharing. Article 17 The state shall establish a biosecurity information release system. Major biosecurity information, such as the overall situation of national biosecurity, major biosecurity risk warning information, major biosecurity events and their investigation and handling information, shall be released by member units of the national biosecurity work coordination mechanism according to their respective responsibilities; other biosecurity information shall be released by relevant departments of the State Council and people’s governments at or above the county level and their relevant departments according to their respective responsibilities and authority. No unit or individual may fabricate or spread false biosecurity information. Article 18 The state establishes a system of biosecurity catalogues and lists. The State Council and its relevant departments, based on the needs of biosecurity work, formulate and announce catalogues or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant diseases, alien invasive species, etc. that involve biosecurity, and dynamically adjust them. Article 19 The state establishes a biosecurity standard system. The State Council’s standardizing authority and other relevant departments of the State Council formulate and improve relevant standards in the field of biosecurity according to their respective responsibilities. The national biosecurity work coordination mechanism shall organize relevant departments to strengthen the coordination and connection of biosecurity standards in different fields, and establish and improve a biosecurity standard system. Article 20 The state establishes a biosecurity review system. Major matters and activities in the biological field that affect or may affect national security shall be subject to biosecurity review by the relevant departments of the State Council to effectively prevent and resolve biosecurity risks. Article 21 The state establishes a biosecurity emergency response system with unified leadership, coordinated operations, and orderly and efficient operation. Relevant departments of the State Council shall organize the formulation of emergency plans for biosecurity incidents in relevant fields and industries, and conduct emergency drills, emergency response, emergency rescue, and post-event recovery in accordance with the emergency plans and unified deployment. People’s governments at or above the county level and their relevant departments shall formulate, organize, guide, and supervise relevant enterprises and institutions in formulating emergency plans for biosecurity incidents, strengthen emergency preparedness, personnel training, and emergency drills, and carry out emergency response, emergency rescue, and post-event recovery for biosecurity incidents. The Chinese People’s Liberation Army and the Chinese People’s Armed Police Force shall participate in the emergency response and emergency rescue of biosecurity incidents in accordance with the orders of the Central Military Commission. Article 22 The state shall establish a system for investigating and tracing the source of biosecurity incidents. In the event of major newly emerging and re-emerging infectious diseases, animal and plant epidemics, and biosecurity incidents of unknown causes, the national biosecurity work coordination mechanism shall organize investigations and source tracing to determine the nature of the incident, comprehensively assess the impact of the incident, and make suggestions. Article 23 The state shall establish a national entry-exit system for animals and plants, animal and plant products, and high-risk biological factors that enter the country for the first time or resume entry after suspension. Entry and exit personnel, transportation vehicles, containers, goods, articles, packaging, and ballast water discharge from international voyages shall comply with China’s biosecurity management requirements. Customs shall deal with discovered biosecurity risks in entry, exit, and transit in accordance with the law. Personnel, transportation vehicles, goods, and articles assessed as high biosecurity risks shall enter through designated border ports and adopt strict risk prevention and control measures. Article 24 The state establishes a response system for major biosecurity events abroad. In the event of major biosecurity events abroad, customs shall take biosecurity emergency prevention and control measures in accordance with the law, strengthen document verification, increase inspection rates, and suspend the entry of relevant personnel, transportation vehicles, goods, and articles. If necessary, with the consent of the State Council, temporary closure of relevant ports and sealing of relevant borders may be adopted. Article 25 Relevant departments of the people’s governments at or above the county level shall conduct biosecurity supervision and inspection work in accordance with the law. Inspected units and individuals shall cooperate, truthfully explain the situation, provide materials, and shall not refuse or obstruct. Biosecurity supervision and inspection work involving high professional and technical requirements and high difficulty in law enforcement business shall involve biosecurity professionals. Article 26 Relevant departments of the people’s governments at or above the county level conducting biosecurity supervision and inspection may take the following measures in accordance with the law: (1) Enter inspected units, locations, or places suspected of engaging in biosecurity violations to conduct on-site monitoring, investigation, inspection, or verification; (2) Understand the situation from relevant units and individuals; (3) Review and copy relevant documents, materials, archives, records, vouchers, etc.; (4) Seal places and facilities suspected of engaging in biosecurity violations; (5) Seize tools, equipment, and related items suspected of engaging in biosecurity violations; (6) Other measures prescribed by laws and regulations. Biosecurity violation information of relevant units and individuals shall be included in the national credit information sharing platform in accordance with the law. Chapter 3 Prevention and Control of Major Newly Emerging and Re-emerging Infectious Diseases and Animal and Plant Epidemics Article 27 The State Council’s departments in charge of health and health, agriculture and rural areas, forestry and grasslands, customs, and ecological environment shall establish a monitoring network for newly emerging and re-emerging infectious diseases, animal and plant epidemics, entry-exit quarantine, and biosafety environmental safety, organize the layout and construction of monitoring sites, improve the monitoring information reporting system, conduct active monitoring and pathogen detection, and include them in the national biosecurity risk monitoring and early warning system. Article 28 Disease prevention and control institutions, animal disease prevention and control institutions, and plant pest and disease prevention and control institutions (hereinafter referred to as professional institutions) shall conduct active monitoring of infectious diseases, animal and plant diseases, and diseases of unknown etiology within the monitoring scope, collect, analyze, and report monitoring information, and predict the occurrence and epidemic trends of newly emerging and re-emerging infectious diseases and animal and plant diseases. Relevant departments of the State Council, people’s governments at or above the county level, and their relevant departments shall issue warnings in a timely manner according to predictions and their responsibilities and take corresponding prevention and control measures. Article 29 Any unit or individual who discovers an infectious disease or animal and plant disease shall promptly report it to a medical institution, relevant professional institution, or department. Medical institutions, professional institutions, and their staff who discover an infectious disease, animal and plant disease, or an unknown cause of clustered diseases shall promptly report and take protective measures. In cases where it is legally required to report, any unit or individual shall not conceal, falsify, delay, or omit reporting, shall not instruct others to conceal, falsify, delay, or omit reporting, and shall not obstruct others from reporting. Article 30 The state shall establish a joint prevention and control mechanism for major newly emerging and re-emerging infectious diseases and animal and plant epidemics. In the event of a major newly emerging and re-emerging infectious disease or animal and plant epidemic, control measures shall be taken in a timely manner in accordance with relevant laws, regulations, and emergency plans; the State Council’s departments in charge of health and health and agriculture and rural areas shall immediately organize an epidemic consultation and judgment, report the conclusions of the consultation and judgment to the central national security leading institution and the State Council, and inform other member units of the national biosecurity work coordination mechanism and other relevant departments of the State Council. In the event of a major newly emerging and re-emerging infectious disease or animal and plant epidemic, local people’s governments at all levels shall uniformly fulfill the responsibilities of epidemic prevention and control within their administrative regions, strengthen organizational leadership, carry out group prevention and control, and medical treatment, mobilize and encourage social forces to participate in epidemic prevention and control work in an orderly manner in accordance with the law. Article 31 The state strengthens the construction of the joint prevention and control capacity of infectious diseases and animal and plant epidemics at borders and ports, establishes an international cooperation network for the prevention and control of infectious diseases and animal and plant epidemics, and discovers and controls major newly emerging and re-emerging infectious diseases and animal and plant epidemics as early as possible. Article 32 The state protects wildlife, strengthens animal disease prevention, and prevents the spread of zoonotic infectious diseases. Article 33 The state strengthens the management of the use and residues of antimicrobial drugs such as antibiotics, supports basic research and technological breakthroughs in addressing microbial resistance. Health authorities of people’s governments at or above the county level shall strengthen the guidance and supervision of rational drug use in medical institutions and take measures to prevent the irrational use of antimicrobial drugs. Agriculture and rural affairs and forestry and grassland authorities of people’s governments at or above the county level shall strengthen the guidance and supervision of rational drug use in agricultural production and take measures to prevent the irrational use of antimicrobial drugs and reduce residues in agricultural production environments. Relevant departments of the State Council in charge of health and health, agriculture and rural areas, forestry and grasslands, ecological environment, and drug supervision and administration shall, in accordance with their respective responsibilities, assess the harm of antimicrobial drug residues to human health and the environment, and establish an antimicrobial drug pollutant indicator evaluation system. Chapter 4 Biosecurity of Biotechnology Research, Development, and Application Article 34 The state strengthens the safety management of biotechnology research, development, and application activities, and prohibits activities that endanger public health, damage biological resources, damage ecosystems and biodiversity, and endanger biosecurity...

Promulgated by the State Council of the People's Republic of China on December 20, 2011 (Order No. 613); First revision according to the State Council's Decision on Amending and Repealing Certain Administrative Regulations of March 1, 2017; Second revision according to the State Council's Decision on Amending and Repealing Certain Administrative Regulations of March 19, 2018

(Adopted at the Eleventh Meeting of the Standing Committee of the Ninth National People's Congress on August 30, 1999; amended according to the Decision of the Standing Committee of the Twelfth National People's Congress on the Amendment of the Bidding and Tendering Law of the People's Republic of China, adopted at its Thirty-first Meeting on December 27, 2017

(Adopted at the 28th Meeting of the Standing Committee of the Eighth National People's Congress on November 1, 1997; First Amendment according to the Decision on Amending the Building Law of the People's Republic of China adopted at the 20th Meeting of the Standing Committee of the Eleventh National People's Congress on April 22, 2011)

(Adopted at the 30th Meeting of the Standing Committee of the Tenth National People's Congress on October 28, 2007; First Amendment according to the Decision on Amending Seven Laws including the PRC Port Law adopted at the 14th Meeting of the Standing Committee of the Twelfth National People's Congress on April 24, 2015)

(Adopted at the 12th Meeting of the Standing Committee of the 12th People's Congress of Jiangxi Province on July 25, 2014, and revised at the 3rd Meeting of the Standing Committee of the 13th People's Congress of Jiangxi Province on May 31, 2018) Table of Contents

Supreme People's Court Provisions on Several Issues Concerning the Application of the Company Law of the People's Republic of China (V)

Supreme People's Court Provisions on Several Issues Concerning the Application of the Company Law of the People's Republic of China (IV)

Supreme People's Court Provisions on Several Issues Concerning the Application of the Company Law of the People's Republic of China (III)

Supreme People's Court Provisions on Several Issues Concerning the Application of the Company Law of the People's Republic of China (II)