Biosafety Law of People's Republic of China (PRC) (China)

Chapter I General Provisions Article 1 This Law is formulated for the purpose of safeguarding national security, preventing and responding to biosafety risks, safeguarding people's lives and health, protecting biological resources and ecological environment, promoting the healthy development of biotechnology, promoting the building of a community of human destiny, and realizing the harmonious coexistence between man and nature. Article 2 Biosafety as mentioned in this Law means that the state effectively guards against and responds to threats from dangerous biological factors and related factors, biotechnology can develop steadily and healthily, people's life and health and ecosystems are relatively in a state of no danger or threat, and the biological field has the ability to safeguard national security and sustainable development.

This Law shall apply to the following activities:

(a) Prevention and control of emerging major 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) Preventing the invasion of alien species and protecting biodiversity;

(six) to deal with microbial resistance;

(seven) to prevent biological terrorist attacks and threats of biological weapons;

(eight) other activities related to biosafety. Article 3 Biosafety is an important part of national security. To maintain biological safety, we should implement the overall national security concept, make overall plans for development and safety, and adhere to the principles of people-oriented, risk prevention, classified management and coordination. Article 4 Adhere to the leadership of China * * * Production Party over national biosafety work, establish and improve the national biosafety leadership system, strengthen the construction of national biosafety risk prevention and control and governance system, and improve the national biosafety governance capacity. Article 5 The State encourages biotechnological innovation, strengthens the biosafety infrastructure and the construction of biotechnological talents, supports the development of bio-industry, improves the biotechnology level through innovation, and enhances the biosafety capability. Article 6 The State shall strengthen international cooperation in the field of biosafety, fulfill the obligations of international treaties concluded or acceded to by People's Republic of China (PRC), support participation in biotechnology exchange and cooperation and international rescue of biosafety incidents, actively participate in the research 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 the publicity and popularization of biosafety laws and regulations and biosafety knowledge, guide grassroots 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 employees.

The news media should carry out public welfare publicity of biosafety laws and regulations and biosafety knowledge, supervise biosafety violations by public opinion, and enhance the public's awareness of social responsibility for safeguarding 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 that receives the report shall promptly handle it according to law. Ninth people's governments at or above the county level and their relevant departments shall, in accordance with the provisions of the state, commend and reward the units and individuals that have made outstanding contributions in the work of biosafety. Chapter II Biosafety Risk Prevention and Control System Article 10 The central national security leading body is responsible for the decision-making and deliberation and coordination of national biosafety work, studying, formulating and guiding the implementation of national biosafety strategies and related major principles and policies, coordinating major national biosafety issues and important work, and establishing a national biosafety work coordination mechanism.

Provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism for biosafety work, and 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 the State Council's health, agriculture, rural areas, science and technology, diplomacy and other relevant military organs, which analyzes and judges the national biosafety situation, organizes, coordinates and urges 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.

Member units of the National Biosafety Coordination Mechanism and other relevant departments of the State Council are responsible for biosafety related work in accordance with the division of responsibilities. Article 12 The National Biosafety Coordination Mechanism shall set up an expert committee to provide decision-making consultation for national biosafety strategy research, policy formulation and implementation.

The relevant departments in the State Council have organized and set up expert committees on biosafety technology consultation in related fields and industries to provide technical support for biosafety work such as consultation, evaluation and demonstration. Thirteenth local people's governments at all levels are responsible for the biological safety 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 biosafety related work in accordance with the division of responsibilities.

Grassroots mass autonomous organizations shall assist local people's governments and relevant departments to do a good job in biosafety risk prevention and control, emergency response and publicity and education.

The relevant units and individuals shall cooperate with the prevention and control of biosafety risks and emergency response. Article 14 The State shall establish a biological safety risk monitoring and early warning system. The national biosafety 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.