Biosafety Law of the People's Republic of China
(Adopted at the 22nd Meeting of the Standing Committee of the 13th National People's Congress on October 17, 2020)
catalogue

Chapter I General Provisions
Chapter II Biosafety Risk Prevention and Control System
Chapter III Prevention and Control of Major New Outbreaks of Infectious Diseases, Animal and Plant Epidemics
Chapter IV Research, Development and Application Safety of Biotechnology
Chapter V Biosafety of Pathogenic Microorganism Laboratory
Chapter VI Human Genetic Resources and Biological Resources Security
Chapter VII Prevention of bioterrorism and the threat of biological weapons
Chapter VIII Biosafety Capacity Building
Chapter IX Legal Liability
Chapter X Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated for the purpose of safeguarding national security, preventing and responding to biosafety risks, protecting people's lives and health, protecting biological resources and ecological environment, promoting the healthy development of biotechnology, promoting the construction of a community with a shared future for mankind, and realizing the harmonious coexistence of man and nature.
Article 2 The term "biosafety" as used in this Law means that the State effectively prevents and responds to the threat of dangerous biological factors and related factors, that biotechnology can develop steadily and healthily, that people's lives, health and ecosystems are relatively in a state of no danger and no threat, and that the biological field has the ability to maintain national security and sustainable development.
This Law applies to the following activities:
（1） To prevent and control major new outbreaks of infectious diseases, animal and plant epidemics;
（2） Research, development and application of biotechnology;
（3） Biosafety management of pathogenic microorganism laboratory;
（4） Safety management of human genetic resources and biological resources;
（5） Prevent the invasion of alien species and protect biodiversity;
（6） Response to microbial resistance;
（7） Prevent bioterrorism attacks and biological weapons threats;
（8） Other activities related to biosafety.
Article 3 Biosafety is an important part of national security. To maintain biosafety, we should implement the overall national security concept, coordinate development and security, and adhere to the principles of people-oriented, risk prevention, classified management, and coordination.
Article 4 Adhere to the leadership of the CPC over the national biosafety work, establish and improve the national biosafety leadership system, strengthen the construction of the national biosafety risk prevention and control and governance system, and improve the national biosafety governance capacity.
Article 5 The State encourages the innovation of biotechnology, strengthens the construction of biosafety infrastructure and the team of biosafety talents, supports the development of the biological industry, improves the level of biotechnology and enhances the ability of biosafety guarantee by innovation-driven.
Article 6 The State strengthens international cooperation in the field of biosafety, performs its obligations under the international treaties concluded or acceded to by the People's Republic of China, supports participation in the exchange and cooperation of biotechnology and the international rescue of biosafety events, actively participates in the research and formulation of international rules on biosafety, and promotes the improvement of global biosafety governance.
Article 7 People's governments at all levels and their relevant departments shall strengthen the publicity and popularization of biosafety laws and regulations and biosafety knowledge, guide grass-roots mass autonomous organizations and social organizations to carry out the publicity of biosafety laws and regulations and biosafety knowledge, and promote the promotion of biosafety awareness of the whole society.
Relevant scientific research institutions, medical institutions and other enterprises and institutions should incorporate biosafety laws and regulations and biosafety knowledge into education and training, and strengthen the cultivation of biosafety awareness and ethical awareness of students and practitioners.
The news media should carry out public welfare publicity of biosafety laws and regulations and biosafety knowledge, conduct public opinion supervision on biosafety violations, and enhance the public's sense of social responsibility to maintain biosafety.
Article 8 No unit or individual may endanger biological safety.
Any unit or individual has the right to report acts endangering biological safety; The department receiving the report shall deal with it in a timely manner according to law.
Article 9 The people's governments at or above the county level and their relevant departments shall commend and reward the units and individuals that have made outstanding contributions to the work of biosafety in accordance with the provisions of the State.
Chapter II Biosafety Risk Prevention and Control System
Article 10 The central national security leading body is responsible for the decision-making, discussion and coordination of the national biosafety work, studying, formulating and guiding the implementation of the national biosafety strategy and relevant major guidelines and policies, coordinating the major issues and important work of national biosafety, and establishing a national biosafety coordination mechanism.
Provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism for biosafety work to organize, coordinate and urge the promotion of biosafety related work within their respective administrative areas.
Article 11 The national biosafety coordination mechanism is composed of the competent departments of health, agriculture and rural areas, science and technology, foreign affairs and other relevant military organs of the State Council, to analyze, study and judge the national biosafety situation, and to organize, coordinate and urge the promotion of national biosafety related work. The national biosafety coordination mechanism has set up an office to be responsible for the daily work of the coordination mechanism.
The member units of the national biosafety coordination mechanism and other relevant departments of the State Council are responsible for biosafety related work according to the division of responsibilities.
Article 12 The national biosafety coordination mechanism shall establish an expert committee to provide decision-making advice for the research, policy formulation and implementation of the national biosafety strategy.
The relevant departments of the State Council shall organize the establishment of biosafety technical advisory expert committees in relevant fields and industries to provide technical support for biosafety work such as consultation, assessment and demonstration.
Article 13 Local people's governments at all levels shall be responsible for the biosafety work within their respective administrative areas.
The relevant departments of the local people's governments at or above the county level shall be responsible for the work related to biosafety according to the division of responsibilities.
Grassroots mass autonomous organizations shall assist local people's governments and relevant departments in the prevention and control of biosafety risks, emergency response, publicity and education, etc.
Relevant units and individuals shall cooperate in the prevention and control of biosafety risks and emergency response.
Article 14 The State establishes a biosafety risk monitoring and early warning system. The national biosafety work coordination mechanism organizes the establishment of a national biosafety risk monitoring and early warning system to improve the ability of biosafety risk identification and analysis.
Article 15 The State shall establish a system of biosafety risk investigation and assessment. The national biosafety coordination mechanism shall regularly organize and carry out biosafety risk investigation and assessment based on the data, information and other information of risk monitoring.
In case of any of the following circumstances, the relevant departments shall promptly carry out biosafety risk investigation and assessment and take necessary risk prevention and control measures according to law:
（1） It is found that there may be biosafety risks through risk monitoring or receiving reports;
（2） In order to determine the key areas and projects of supervision and management, develop and adjust the biosafety related directory or list;
（3） Occurrence of major new outbreaks of infectious diseases, animal and plant epidemics and other events endangering biological safety;
（4） Other situations requiring investigation and evaluation.
Article 16 The State establishes a biosafety information sharing system. The national biosafety coordination mechanism shall organize the establishment of a unified national biosafety information platform, and relevant departments shall submit biosafety data, information and other information to the national biosafety information platform to realize information sharing.
Article 17 The State establishes a system for the release of biosafety information. Major biosafety information such as the overall national biosafety situation, major biosafety risk warning information, major biosafety events and their investigation and handling information shall be released by the member units of the national biosafety coordination mechanism according to the division of responsibilities; Other biosafety information shall be released by the relevant departments of the State Council, the local people's governments at or above the county level and their relevant departments according to their functions and powers.
No unit or individual may fabricate or disseminate false biosafety information.
Article 18 The State establishes a system of biosafety directories and inventories. The State Council and its relevant departments shall, in accordance with the needs of biosafety work, formulate and publish lists or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant epidemics, and invasive alien species that are related to biosafety, and make dynamic adjustments.
Article 19 The State establishes a system of biosafety standards. The standardization department of the State Council and other relevant departments of the State Council shall formulate and improve relevant standards in the field of biosafety according to the division of responsibilities.
The national biosafety coordination mechanism organizes relevant departments to strengthen the coordination and connection of biosafety standards in different fields, and establish and improve the biosafety standard system.
Article 20 The State establishes a biosafety review system. For major biological issues and activities that affect or may affect national security, the relevant departments of the State Council shall conduct a biosafety review to effectively prevent and resolve biosafety risks.
Article 21 The State establishes an orderly and efficient biosafety emergency system with unified leadership, coordination and linkage.
The relevant departments of the State Council shall organize the formulation of emergency plans for biosafety incidents in relevant fields and industries, and carry out emergency drills, emergency disposal, emergency rescue and post-recovery work according to the 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 biosafety incidents, strengthen emergency preparedness, personnel training and emergency drills, and carry out emergency response, emergency rescue and post-recovery of biosafety incidents.
The Chinese People's Liberation Army and the Chinese People's Armed Police Force, in accordance with the order of the Central Military Commission, participate in the emergency response and emergency rescue of biosafety incidents according to law.
Article 22 The State establishes a system of investigation and tracing of biosafety incidents. In the event of major new and emergent infectious diseases, animal and plant epidemics and unknown biosafety events, the national biosafety coordination mechanism shall organize investigation and tracing, determine the nature of the event, comprehensively assess the impact of the event, and put forward suggestions.
Article 23 The State establishes a national access 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.
Inbound and outbound personnel, means of transport, containers, goods, articles, packages and ballast water discharge of international navigation ships shall meet the requirements of China's biosafety management.
The customs shall deal with the biosafety risks found in entry, exit and transit according to law. Personnel, means of transport, goods, articles, etc. assessed as high risk of biosafety shall enter the country from the designated frontier port and take strict risk prevention and control measures.
Article 24 The State establishes a response system for major overseas biosafety incidents. In case of major biosafety incidents outside China, the Customs shall take emergency biosafety prevention and control measures according to law, strengthen the verification of certificates, increase the proportion of inspection, and suspend the entry of relevant personnel, means of transport, goods, articles, etc. When necessary, with the consent of the State Council, measures such as temporary closure of relevant ports and blockade of relevant borders may be taken.
Article 25 The relevant departments of the people's governments at or above the county level shall carry out the supervision and inspection of biological safety according to law. The units and individuals under inspection shall cooperate, truthfully explain the situation and provide information, and shall not refuse or obstruct.
The supervision and inspection work involving high professional and technical requirements and difficult law enforcement business should be attended by professional and technical personnel of biosafety.
Article 26 The relevant departments of the people's governments at or above the county level may take the following measures according to law when implementing the supervision and inspection of biological safety:
（1） Enter the unit or place under inspection or the place suspected of carrying out biosafety violations for on-site monitoring, investigation, inspection or verification;
（2） Learn about the situation from relevant units and individuals;
（3） Review and copy relevant documents, data, archives, records, vouchers, etc;
（4） Seal up the places and facilities suspected of committing biosafety violations;
（5） Seize tools, equipment and related articles suspected of committing biosafety violations;
（6） Other measures stipulated by laws and regulations.
The biosafety illegal information of relevant units and individuals shall be incorporated into the national credit information sharing platform according to law.
Chapter III Prevention and Control of Major New Outbreaks of Infectious Diseases, Animal and Plant Epidemics
Article 27 The competent departments of health, agriculture, rural areas, forestry, grassland, customs and ecological environment under the State Council shall establish a monitoring network for newly emerging infectious diseases, animal and plant epidemics, entry and exit quarantine, biotechnology and environmental safety, organize the layout and construction of monitoring stations, improve the monitoring information reporting system, carry out active monitoring and pathogen detection, and incorporate it into the national biosafety risk monitoring and early warning system.
Article 28 Disease prevention and control institutions, animal epidemic prevention and control institutions, and plant disease and insect pest prevention and control institutions (hereinafter referred to as professional institutions) shall actively monitor infectious diseases, animal and plant epidemics and diseases of unknown causes included in the scope of monitoring, collect, analyze, and report monitoring information, and predict the occurrence and epidemic trend of emerging infectious diseases, animal and plant epidemics.
The relevant departments of the State Council, the local people's governments at or above the county level and their relevant departments shall timely issue early warning and take corresponding preventive and control measures in accordance with the forecast and their functions and powers.
Article 29 Any unit or individual that discovers infectious diseases, animal and plant epidemics shall promptly report to medical institutions, relevant professional institutions or departments.
If medical institutions, professional institutions and their staff find infectious diseases, animal and plant epidemics or diseases of unknown origin, they shall timely report and take protective measures.
Where a report is required by law, no unit or individual shall conceal, lie, delay or omit the report, or encourage others to conceal, lie or delay the report, or hinder others from reporting.
Article 30 The State shall establish a joint prevention and control mechanism for major emerging infectious diseases, animal and plant epidemics.
In the event of a major new outbreak of infectious diseases, animal and plant epidemics, control measures shall be taken in a timely manner in accordance with the provisions of relevant laws and regulations and emergency plans; The competent departments of health, agriculture, rural areas, forestry and grassland under the State Council shall immediately organize the epidemic situation consultation and judgment, report the conclusions of the consultation and judgment to the central national security leading body and the State Council, and notify other members of the national biosafety coordination mechanism and other relevant departments of the State Council.
In the event of major new outbreaks of infectious diseases, animal and plant epidemics, local people's governments at all levels uniformly perform their duties of epidemic prevention and control within their administrative areas, strengthen organizational leadership, carry out mass prevention and control, and medical treatment, and mobilize and encourage social forces to participate in epidemic prevention and control in an orderly manner according to law.
Article 31 The State strengthens the construction of the joint prevention and control capacity of infectious diseases and animal and plant epidemics at the border and port, establishes an international cooperation network for the prevention and control of infectious diseases, animal and plant epidemics, and discovers and controls major new outbreaks of infectious diseases, animal and plant epidemics as soon as possible.
Article 32 The State protects wild animals, strengthens animal epidemic prevention and prevents the spread of infectious diseases of animal origin.
Article 33 The State strengthens the management of the use and residue of anti-microbial drugs such as antibiotics, and supports the basic research and scientific and technological breakthroughs in the response to microbial resistance.
The competent health department of the people's government at or above the county level shall strengthen the guidance and supervision of the rational use of drugs by medical institutions and take measures to prevent the irrational use of anti-microbial drugs. The departments in charge of agriculture, rural areas, forestry and grassland under the people's governments at or above the county level shall strengthen the guidance and supervision of the rational use of anti-microbial drugs in agricultural production, take measures to prevent the irrational use of anti-microbial drugs and reduce the residues in the agricultural production environment.
The competent departments of health, agriculture, rural areas, forestry, grassland and ecological environment under the State Council and the drug administration