Biosecurity Law of the People's Republic of China (Amended in 2024)
Biosecurity Law of the People's Republic of China (Amended in 2024)
Biosecurity Law of the People's Republic of China (Amended in 2024)
Order of the President of the People's Republic of China No. 24
April 26, 2024
(Adopted at the 22nd Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China on October 17, 2020; amended according to the Decision on Amending the Law of the People's Republic of China on the Promotion of Agricultural Technology, the Law of the People's Republic of China on the Protection of Minors, and the Biosecurity Law of the People's Republic of China at the ninth session of the Standing Committee of the 14th National People's Congress on April 26, 2024)
Table of Contents
Chapter I General Provisions
Chapter II Prevention and Control System of Biosecurity Risks
Chapter III Prevention and Control of New Serious Communicable Diseases and Animal and Plant Epidemics
Chapter IV Biotechnological Research, Development and Application Security
Chapter V Laboratory Biosecurity of Pathogenic Microorganisms
Chapter VI Security of Human Genetic Resources and Biological Resources
Chapter VII Prevention of Bioterrorism and Biological Weapon Threats
Chapter VIII Biosecurity Capability Building
Chapter IX Legal Liability
Chapter X Supplementary Provisions
Chapter I General Provisions
Article 1 The Law is hereby formulated in a bid to maintain state security, prevent and respond to biosecurity risks, guarantee people's life and health, protect biological resources and the ecological environment, promote the sound development of biotechnology, propel the construction of a shared future for mankind, and achieve the harmonious coexistence of mankind and nature.
Article 2 For the purpose of the Law, biosecurity means that the State effectively prevents and responds to threats from dangerous biological factors and the relevant elements, maintains the stable and sound development of biotechnology, relatively falls into a situation of no danger or threat in terms of people's life and health and ecosystem, and is capable of guaranteeing state security and sustainable development in the biological field.
The Law shall apply to the following activities:
1. preventing and controlling new serious communicable diseases and animal and plant epidemics;
2. researching, developing and applying biotechnology;
3. managing the laboratory biosecurity of pathogenic microorganisms;
4. managing the security of human genetic resources and biological resources;
5. preventing the invasion of alien species and protecting biodiversity;
6. coping with microbial resistance;
7. preventing bioterrorism and defending against biological weapon threats; and
8. any other activity related to biosecurity.
Article 3 Biosecurity is an important ingredient of the state security. In order to maintain biosecurity, it is imperative to carry out the overall national security outlook, coordinate development and security, and insist on the principles of being oriented by people, risk prevention, classified management and collaboration.
Article 4 It is necessary to persist in the leadership of the Communist Party of China for the state biosecurity work, establish and perfect a state biosecurity leadership system, intensify the construction of the state biosecurity risk prevention and control and governance systems, and improve the state biosecurity governance capability.
Article 5 The State encourages biotechnology innovation, intensifies biosecurity infrastructure and biotechnology talent team building, supports the development of the biological industry, is improving the level of biotechnology by innovation, and enhancing biosecurity guarantee capability.
Article 6 The State shall reinforce the international cooperation in the biosecurity field, fulfill the obligations set out in international treaties that the People's Republic of China has concluded or joined, support the participation in biotechnology exchanges and cooperation and international rescue during biosecurity events, actively take part in the research and formulation of international rules for biosecurity, and promote the improvement of global biosecurity governance.
Article 7 People's governments at all levels and the relevant departments thereof shall reinforce the publicity and popularization of biosecurity laws, regulations and knowledge, guide grassroots mass self-governance organizations and social organizations to publicize biosecurity laws, regulations and knowledge, and promote the improvement of the sense of biosecurity of the whole of society.
The relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall include biosecurity laws, regulations and knowledge in education and training contents, and reinforce the cultivation of the sense and ethical consciousness of biosecurity of students and practitioners.
News media shall conduct public welfare publicity for biosecurity laws, regulations and knowledge, supervise biosecurity illegal behaviors in the light of public opinion, and intensify the public's sense of social responsibilities for maintaining biosecurity.
Article 8 No entity or individual shall harm biosecurity.
Any entity or individual is entitled to report any behavior that is harming biosecurity; the department receiving a report shall carry out handling of such behavior according to the law in due time.
Article 9 People's governments at or above the county level and the relevant departments thereof shall commend and reward any entity or individual who makes outstanding contributions to biosecurity work in accordance with the national provisions.
Chapter II Prevention and Control System of Biosecurity Risks
Article 10 The central leadership organ of state security shall be responsible for the decision and agenda coordination of the state biosecurity work, research, formulate, guide and implement the state biosecurity strategies and the relevant major guidelines and policies, generally coordinate the major matters and important work of state biosecurity, and establish a coordination mechanism for state biosecurity.
Provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism for biosecurity, and organize, coordinate, urge and impel biosecurity-related work within their respective administrative regions.
Article 11 The coordination mechanism for state biosecurity, composed of the competent departments of health, agriculture and rural affairs, scientific technology, diplomacy, etc. and the relevant military organ under the State Council, analyzes and judges the state biosecurity situation, and organizes, coordinates, urges and impels state biosecurity-related work. The coordination mechanism for state biosecurity has set up an office to be responsible for its daily work.
Members of the coordination mechanism for state biosecurity and other relevant departments under the State Council shall take charge of the biosecurity-related work as per their respective duties.
Article 12 The coordination mechanism for state biosecurity shall establish an expert committee to provide decision consultations for the study, formulation and implementation of state biosecurity strategies and policies.
The relevant department under the State Council shall organize and establish a committee of biosecurity technology consulting experts in the relevant fields and industries to provide consultations, evaluations, demonstrations and other technical supports for biosecurity.
Article 13 Local people's governments at all levels are responsible for the biosecurity within their respective administrative regions.
The relevant departments of local people's governments at or above the county level are responsible for biosecurity-related work as per their respective duties.
Grassroots mass self-governance organizations shall assist local people's governments and the relevant departments thereof in the prevention and control of biosecurity risks, emergency response, publicity and education.
The relevant entities and individuals shall cooperate in the prevention and control of biosecurity risks and emergency response.
Article 14 The State shall establish a biosecurity risk monitoring and early warning system. The coordination mechanism for state biosecurity shall organize the establishment of a state biosecurity risk monitoring and early warning system, and enhance the capabilities of biosecurity risk identification and analysis.
Article 15 The State shall establish a state biosecurity risk investigation and evaluation system. The coordination mechanism for state biosecurity shall, as per risk monitoring data, materials and other information, regularly organize biosecurity risk investigations and evaluations.
In any of the following circumstances, the relevant departments shall conduct biosecurity risk investigations and evaluations in a timely manner, and take necessary risk prevention and control measures according to the law:
1. it is found through risk monitoring or any report received that there may be any biosecurity risk;
2. any biosecurity-related directory or list is worked out or adjusted in order to determine major fields and projects of supervision and administration;
3. any new serious communicable disease or animal or plant epidemic or any other event that harms biosecurity occurs; or
4. other circumstances under which it is necessary to conduct investigations and evaluations.
Article 16 The State shall establish a biosecurity information sharing system. The coordination mechanism for state biosecurity shall organize and establish a unified state biosecurity information platform, and the relevant departments shall submit information such as biosecurity data and materials to the aforesaid platform, to realize information sharing.
Article 17 The State shall establish an issue system of biosecurity information. Members of the coordination mechanism for state biosecurity shall, as per their respective duties, release major biosecurity information such as the overall situations of state biosecurity, warning information about major biosecurity risks, major biosecurity events and their investigation and treatment information; the relevant departments under the State Council, and local people's governments at or above the county level and the relevant departments thereof shall, as per their respective duties, shall release other biosecurity information.
No entity or individual shall fabricate or spread any false biosecurity information.
Article 18 The State shall establish a biosecurity directory and list system. The State Council and the relevant departments under the State Council shall, as per biosecurity work demands, prepare and publish directories or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant epidemics, alien invasive species and so on relating to biosecurity, and dynamically adjust them.
Article 19 The State shall establish a biosecurity standard system.
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Order of the President of the People's Republic of China No. 24
April 26, 2024
(Adopted at the 22nd Session of the Standing Committee of the 13th National People's Congress of the People's Republic of China on October 17, 2020; amended according to the Decision on Amending the Law of the People's Republic of China on the Promotion of Agricultural Technology, the Law of the People's Republic of China on the Protection of Minors, and the Biosecurity Law of the People's Republic of China at the ninth session of the Standing Committee of the 14th National People's Congress on April 26, 2024)
Table of Contents
Chapter I General Provisions
Chapter II Prevention and Control System of Biosecurity Risks
Chapter III Prevention and Control of New Serious Communicable Diseases and Animal and Plant Epidemics
Chapter IV Biotechnological Research, Development and Application Security
Chapter V Laboratory Biosecurity of Pathogenic Microorganisms
Chapter VI Security of Human Genetic Resources and Biological Resources
Chapter VII Prevention of Bioterrorism and Biological Weapon Threats
Chapter VIII Biosecurity Capability Building
Chapter IX Legal Liability
Chapter X Supplementary Provisions
Chapter I General Provisions
Article 1 The Law is hereby formulated in a bid to maintain state security, prevent and respond to biosecurity risks, guarantee people's life and health, protect biological resources and the ecological environment, promote the sound development of biotechnology, propel the construction of a shared future for mankind, and achieve the harmonious coexistence of mankind and nature.
Article 2 For the purpose of the Law, biosecurity means that the State effectively prevents and responds to threats from dangerous biological factors and the relevant elements, maintains the stable and sound development of biotechnology, relatively falls into a situation of no danger or threat in terms of people's life and health and ecosystem, and is capable of guaranteeing state security and sustainable development in the biological field.
The Law shall apply to the following activities:
1. preventing and controlling new serious communicable diseases and animal and plant epidemics;
2. researching, developing and applying biotechnology;
3. managing the laboratory biosecurity of pathogenic microorganisms;
4. managing the security of human genetic resources and biological resources;
5. preventing the invasion of alien species and protecting biodiversity;
6. coping with microbial resistance;
7. preventing bioterrorism and defending against biological weapon threats; and
8. any other activity related to biosecurity.
Article 3 Biosecurity is an important ingredient of the state security. In order to maintain biosecurity, it is imperative to carry out the overall national security outlook, coordinate development and security, and insist on the principles of being oriented by people, risk prevention, classified management and collaboration.
Article 4 It is necessary to persist in the leadership of the Communist Party of China for the state biosecurity work, establish and perfect a state biosecurity leadership system, intensify the construction of the state biosecurity risk prevention and control and governance systems, and improve the state biosecurity governance capability.
Article 5 The State encourages biotechnology innovation, intensifies biosecurity infrastructure and biotechnology talent team building, supports the development of the biological industry, is improving the level of biotechnology by innovation, and enhancing biosecurity guarantee capability.
Article 6 The State shall reinforce the international cooperation in the biosecurity field, fulfill the obligations set out in international treaties that the People's Republic of China has concluded or joined, support the participation in biotechnology exchanges and cooperation and international rescue during biosecurity events, actively take part in the research and formulation of international rules for biosecurity, and promote the improvement of global biosecurity governance.
Article 7 People's governments at all levels and the relevant departments thereof shall reinforce the publicity and popularization of biosecurity laws, regulations and knowledge, guide grassroots mass self-governance organizations and social organizations to publicize biosecurity laws, regulations and knowledge, and promote the improvement of the sense of biosecurity of the whole of society.
The relevant scientific research institutions, medical institutions, and other enterprises and public institutions shall include biosecurity laws, regulations and knowledge in education and training contents, and reinforce the cultivation of the sense and ethical consciousness of biosecurity of students and practitioners.
News media shall conduct public welfare publicity for biosecurity laws, regulations and knowledge, supervise biosecurity illegal behaviors in the light of public opinion, and intensify the public's sense of social responsibilities for maintaining biosecurity.
Article 8 No entity or individual shall harm biosecurity.
Any entity or individual is entitled to report any behavior that is harming biosecurity; the department receiving a report shall carry out handling of such behavior according to the law in due time.
Article 9 People's governments at or above the county level and the relevant departments thereof shall commend and reward any entity or individual who makes outstanding contributions to biosecurity work in accordance with the national provisions.
Chapter II Prevention and Control System of Biosecurity Risks
Article 10 The central leadership organ of state security shall be responsible for the decision and agenda coordination of the state biosecurity work, research, formulate, guide and implement the state biosecurity strategies and the relevant major guidelines and policies, generally coordinate the major matters and important work of state biosecurity, and establish a coordination mechanism for state biosecurity.
Provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism for biosecurity, and organize, coordinate, urge and impel biosecurity-related work within their respective administrative regions.
Article 11 The coordination mechanism for state biosecurity, composed of the competent departments of health, agriculture and rural affairs, scientific technology, diplomacy, etc. and the relevant military organ under the State Council, analyzes and judges the state biosecurity situation, and organizes, coordinates, urges and impels state biosecurity-related work. The coordination mechanism for state biosecurity has set up an office to be responsible for its daily work.
Members of the coordination mechanism for state biosecurity and other relevant departments under the State Council shall take charge of the biosecurity-related work as per their respective duties.
Article 12 The coordination mechanism for state biosecurity shall establish an expert committee to provide decision consultations for the study, formulation and implementation of state biosecurity strategies and policies.
The relevant department under the State Council shall organize and establish a committee of biosecurity technology consulting experts in the relevant fields and industries to provide consultations, evaluations, demonstrations and other technical supports for biosecurity.
Article 13 Local people's governments at all levels are responsible for the biosecurity within their respective administrative regions.
The relevant departments of local people's governments at or above the county level are responsible for biosecurity-related work as per their respective duties.
Grassroots mass self-governance organizations shall assist local people's governments and the relevant departments thereof in the prevention and control of biosecurity risks, emergency response, publicity and education.
The relevant entities and individuals shall cooperate in the prevention and control of biosecurity risks and emergency response.
Article 14 The State shall establish a biosecurity risk monitoring and early warning system. The coordination mechanism for state biosecurity shall organize the establishment of a state biosecurity risk monitoring and early warning system, and enhance the capabilities of biosecurity risk identification and analysis.
Article 15 The State shall establish a state biosecurity risk investigation and evaluation system. The coordination mechanism for state biosecurity shall, as per risk monitoring data, materials and other information, regularly organize biosecurity risk investigations and evaluations.
In any of the following circumstances, the relevant departments shall conduct biosecurity risk investigations and evaluations in a timely manner, and take necessary risk prevention and control measures according to the law:
1. it is found through risk monitoring or any report received that there may be any biosecurity risk;
2. any biosecurity-related directory or list is worked out or adjusted in order to determine major fields and projects of supervision and administration;
3. any new serious communicable disease or animal or plant epidemic or any other event that harms biosecurity occurs; or
4. other circumstances under which it is necessary to conduct investigations and evaluations.
Article 16 The State shall establish a biosecurity information sharing system. The coordination mechanism for state biosecurity shall organize and establish a unified state biosecurity information platform, and the relevant departments shall submit information such as biosecurity data and materials to the aforesaid platform, to realize information sharing.
Article 17 The State shall establish an issue system of biosecurity information. Members of the coordination mechanism for state biosecurity shall, as per their respective duties, release major biosecurity information such as the overall situations of state biosecurity, warning information about major biosecurity risks, major biosecurity events and their investigation and treatment information; the relevant departments under the State Council, and local people's governments at or above the county level and the relevant departments thereof shall, as per their respective duties, shall release other biosecurity information.
No entity or individual shall fabricate or spread any false biosecurity information.
Article 18 The State shall establish a biosecurity directory and list system. The State Council and the relevant departments under the State Council shall, as per biosecurity work demands, prepare and publish directories or lists of materials, equipment, technologies, activities, important biological resource data, infectious diseases, animal and plant epidemics, alien invasive species and so on relating to biosecurity, and dynamically adjust them.
Article 19 The State shall establish a biosecurity standard system.
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