Article 1 This Law is enacted to safeguard national security, prevent and respond to biosafety risks, protect the health and lives of the people, conserve biological resources and the ecological environment, promote the sound development of biotechnology, advance the building of a community with a shared future for mankind, and achieve harmonious coexistence between humanity and nature.

Article 2 For the purposes of this Law, “biosafety” means the State’s effective prevention and response to threats posed by hazardous biological agents and related factors; the stable and healthy development of biotechnology; a state in which the lives and health of the people and ecosystems are relatively free from danger and threat; and the capacity of the bioscience sector to safeguard national security and promote sustainable development.

This Law shall apply to the following activities:

(1) Prevention and control of major emerging and sudden infectious diseases, as well as animal and plant epidemics;

(2) Research, development, and application of biotechnology;

(3) Biosafety management of pathogenic microorganism laboratories;

(4) Safety management of human genetic resources and biological resources;

(5) Preventing the invasion of alien species and protecting biodiversity;

(6) Addressing microbial resistance;

(7) Preventing bioterrorist attacks and defending against the threat of biological weapons;

(8) Other activities related to biosafety.

Article 3. Biosafety is an important component of national security. Safeguarding biosafety shall be guided by the holistic approach to national security, balance development with security, and adhere to the principles of people-oriented governance, risk prevention, categorized management, and coordinated collaboration.

Article 4: Uphold the leadership of the Communist Party of China over national biosafety work, establish and improve the national biosafety leadership system, strengthen the building of the national biosafety risk prevention and control and governance system, and enhance the capacity for national biosafety governance.

Article 5 The State encourages innovation in biotechnology, strengthens biosecurity infrastructure and the development of a skilled workforce in biotechnology, supports the development of the biotechnology industry, and leverages innovation to elevate the level of biotechnology and enhance biosecurity capabilities.

Article 6 The State shall strengthen international cooperation in the field of biosafety, fulfill its obligations under international treaties to which the People’s Republic of China is a party or has acceded, support participation in exchanges and cooperation in biotechnology and in international rescue operations for biosafety incidents, actively engage in the study and formulation of international rules on biosafety, and promote the improvement of global biosafety governance.

Article 7: People’s governments at all levels and their relevant departments shall strengthen publicity and education on biosafety laws, regulations, and related knowledge, guide grassroots mass self-governing organizations and social organizations in carrying out such publicity and education, and promote the enhancement of biosafety awareness throughout society.

Relevant research institutions, medical organizations, and other enterprises and public institutions shall incorporate biosafety laws and regulations and biosafety knowledge into their education and training programs, and strengthen the cultivation of biosafety awareness and ethical consciousness among students and professionals.

News media shall conduct public awareness campaigns on biosafety laws and regulations and on biosafety knowledge, exercise public oversight over violations of biosafety laws and regulations, and enhance the public’s sense of social responsibility for safeguarding biosafety.

Article 8 No organization or individual shall endanger biosafety.

Any organization or individual has the right to report acts that endanger biosafety; the competent authorities receiving such reports shall promptly handle them in accordance with the law.

Article 9: Units and individuals that have made outstanding contributions to biosafety work shall be commended and rewarded by people’s governments at or above the county level and their relevant departments in accordance with national regulations.

Article 10 The central national security leading body shall be responsible for decision-making, deliberation, and coordination of national biosecurity work; shall formulate and guide the implementation of the national biosecurity strategy and related major principles and policies; shall comprehensively coordinate major matters and important tasks concerning national biosecurity; and shall establish a coordination mechanism for national biosecurity work.

Provinces, autonomous regions, and municipalities directly under the central government shall establish coordination mechanisms for biosafety work to organize, coordinate, and supervise and promote biosafety-related activities within their respective administrative jurisdictions.

Article 11 The National Biosafety Coordination Mechanism shall be composed of the competent authorities under the State Council in the fields of health, agriculture and rural affairs, science and technology, and foreign affairs, as well as relevant military organs. It shall analyze and assess the national biosafety situation and organize, coordinate, and supervise the advancement of work related to national biosafety. An office shall be established under the National Biosafety Coordination Mechanism to undertake its day-to-day operations.

Member units of the National Coordination Mechanism for Biosafety and other relevant departments of the State Council shall, in accordance with their respective responsibilities, be responsible for biosafety-related work.

Article 12 The National Coordination Mechanism for Biosafety shall establish an Expert Committee to provide decision-making advice on research into the national biosafety strategy, as well as on the formulation and implementation of related policies.

Relevant departments of the State Council shall organize and establish expert committees on biosafety technical consultation in related fields and industries to provide technical support, including consultation, assessment, and feasibility studies, for biosafety work.

Article 13: People’s governments at all levels in local areas shall be responsible for biosafety work within their respective administrative jurisdictions.

Relevant departments of people’s governments at or above the county level shall, in accordance with their respective responsibilities, be responsible for biosafety-related work.

Grassroots mass self-governing organizations shall assist the local people’s governments and relevant departments in carrying out biosafety risk prevention and control, emergency response, and public education and awareness-raising.

Relevant organizations and individuals shall cooperate in carrying out biosafety risk prevention and control as well as emergency response measures.

Article 14 The State shall establish a biosafety risk monitoring and early-warning system. The National Coordination Mechanism for Biosafety Work shall organize the establishment of a national biosafety risk monitoring and early-warning system to enhance the capacity for identifying and analyzing biosafety risks.

Article 15 The State shall establish a system for the investigation and assessment of biosafety risks. The State Coordination Mechanism for Biosafety Work shall, on the basis of data, materials, and other information obtained through risk monitoring, regularly organize and conduct investigations and assessments of biosafety risks.

Where any of the following circumstances exists, the relevant authorities shall promptly conduct a biosafety risk assessment and, in accordance with the law, adopt necessary risk prevention and control measures:

(1) Potential biosafety risks are identified through risk monitoring or upon receipt of reports;

(2) To identify priority areas and key projects for supervision and management, formulate or revise lists or inventories related to biosafety;

(3) The occurrence of major emerging and sudden infectious diseases, animal and plant epidemics, or other events that pose a threat to biosafety;

(4) Other circumstances requiring investigation and assessment.

Article 16 The State shall establish a system for the sharing of biosafety information. The State Coordination Mechanism for Biosafety Work shall organize the establishment of a unified national biosafety information platform, and the relevant departments shall submit biosafety data, materials, and other information to the platform to achieve information sharing.

Article 17 The State shall establish a system for the release of biosafety information. Major biosafety information, including the overall national biosafety situation, alerts on major biosafety risks, and information on major biosafety incidents and their investigation and handling, shall be released by the member units of the National Biosafety Coordination Mechanism in accordance with their respective responsibilities; other biosafety information shall be released by the relevant departments of the State Council and by people’s governments at or above the county level and their respective competent departments in accordance with their respective powers and responsibilities.

No organization or individual shall fabricate or disseminate false biosafety information.

Article 18 The State shall establish a system of biosafety catalogs and lists. The State Council and its relevant departments, in accordance with the needs of biosafety work, shall formulate and publish catalogs or lists covering materials, equipment, technologies, activities, critical biological resource data, infectious diseases, animal and plant epidemics, and invasive alien species, and shall make dynamic adjustments thereto.

Article 19 The State shall establish a system of biosafety standards. The standardization administrative department under the State Council and other relevant departments of the State Council shall, in accordance with their respective responsibilities, formulate and improve standards related to biosafety.

The National Coordination Mechanism for Biosafety Work shall organize relevant departments to strengthen the coordination and alignment of biosafety standards across different sectors and to establish and improve the biosafety standards system.

Article 20 The State shall establish a biosecurity review system. Major matters and activities in the biological field that have or may have an impact on national security shall be subject to biosecurity review by the relevant departments of the State Council, so as to effectively prevent and mitigate biosecurity risks.

Article 21 The State shall establish a biosecurity emergency response system characterized by unified leadership, coordinated collaboration, and orderly efficiency.

Relevant departments of the State Council shall organize the formulation of emergency response plans for biosafety incidents in respective fields and industries, and, in accordance with these plans and unified arrangements, conduct emergency drills, emergency response, emergency rescue, and post-incident recovery activities.

People’s governments at or above the county level and their relevant departments shall formulate, organize, guide, and supervise relevant enterprises and public institutions in developing emergency response plans for biosafety incidents; strengthen emergency preparedness, personnel training, and emergency drills; and carry out emergency response, emergency rescue, and post-incident recovery efforts related to biosafety incidents.

The People’s Liberation Army of China and the People’s Armed Police Force of China shall, in accordance with the orders of the Central Military Commission, participate in emergency response and rescue operations for biosafety incidents in accordance with the law.

Article 22 The State shall establish a system for investigating and tracing the origins of biosafety incidents. In the event of major emerging and sudden infectious diseases, animal and plant epidemics, or biosafety incidents of unknown cause, the National Biosafety Coordination Mechanism shall organize and conduct investigations to determine the nature of the incident, comprehensively assess its impact, and put forward recommendations and suggestions.

Article 23 The State shall establish a national access system for animals and plants, animal and plant products, and high-risk biological agents that are being imported for the first time or whose import has been suspended and is now being resumed.

Personnel, means of transport, containers, goods, articles, packaging materials, and ballast water discharged from internationally navigating vessels entering or leaving the country shall comply with China’s biosafety management requirements.

Customs authorities shall, in accordance with the law, handle any biosecurity risks identified in import, export, or transit activities. Persons, means of transport, goods, articles, and other items assessed as posing a high biosecurity risk shall enter through designated border ports and be subject to stringent risk-control measures.

Article 24 The State shall establish a response mechanism for major biosafety incidents occurring abroad. In the event of a major biosafety incident abroad, customs authorities shall, in accordance with the law, implement emergency biosafety control measures, strengthen document verification, increase inspection rates, and suspend the import of relevant personnel, means of transport, goods, articles, and other items. Where necessary and with the approval of the State Council, temporary closure of relevant ports of entry and sealing off of relevant border areas may be imposed.

Article 25: Relevant departments of people’s governments at or above the county level shall, in accordance with the law, conduct biosecurity supervision and inspection. Entities and individuals subject to such inspections shall cooperate, truthfully explain the relevant circumstances, and provide pertinent materials; they may not refuse or obstruct such inspections.

Supervisory and inspection activities that involve high technical expertise and pose significant challenges in law enforcement shall be conducted with the participation of biosafety professionals.

Article 26: Relevant departments of people’s governments at or above the county level, when conducting biosafety supervision and inspection, may, in accordance with the law, take the following measures:

(1) Entering the entity or location subject to inspection, or any premises suspected of engaging in biosecurity violations, to conduct on-site monitoring, surveying, inspection, or verification;

(2) Obtain information from relevant organizations and individuals;

(3) Examining and copying relevant documents, materials, archives, records, vouchers, and other related items;

(4) Seize premises and facilities suspected of being used to commit biosecurity violations;

(5) Seize tools, equipment, and related items suspected of being used to commit biosecurity violations;

(6) Other measures prescribed by laws and regulations.

Information on biosecurity violations by relevant entities and individuals shall, in accordance with the law, be incorporated into the National Credit Information Sharing Platform.

Article 27 The State Council’s departments in charge of health, agriculture and rural affairs, forestry and grassland, customs, and ecological environment shall establish a monitoring network for emerging and sudden infectious diseases, animal and plant epidemics, import–export quarantine, and biosafety in biotechnology; organize the planning and construction of monitoring stations; improve the monitoring information reporting system; conduct proactive surveillance and pathogen testing; and integrate these activities 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 pest and disease prevention and control institutions (hereinafter collectively referred to as “specialized institutions”) shall conduct proactive surveillance of infectious diseases, animal and plant epidemics, and unexplained diseases included in the monitoring scope; collect, analyze, and report surveillance data; and forecast the occurrence and epidemiological trends of emerging and sudden infectious diseases and animal and plant epidemics.

Relevant departments of the State Council and people’s governments at or above the county level, together with their respective competent departments, shall, in accordance with forecasts and within their respective powers and responsibilities, promptly issue early warnings and implement appropriate prevention and control measures.

Article 29 Any organization or individual who discovers an infectious disease or an animal or plant epidemic shall promptly report it to a medical institution, the relevant specialized agency, or the competent department.

Medical institutions, specialized agencies, a