Chapter IV Security of Biotechnology Research, Development and Application

Article 34  The state strengthens the security management of biotechnology research, development and application activities, and prohibits those activities  that may threaten the public health, damage the living resources or threaten biodiversity.

Biotechnology research, development and application shall follow ethical principles.

Article 35  Entities that engage in biotechnology research, development and application shall be responsible for the security of their own activities in biotechnology research, development and application, adopt measures for the prevention and control of biosecurity risks, formulate working procedures for biosecurity-related training, follow-up inspection, and regular report so as to strengthen the process management.

Article 36  The state adopts classified management as regards biotechnology research and development activities. These activities shall be classified as high-risk, medium-risk, and low-risk activities according to the degree of potential harm to the public health, industry, agriculture, and ecological environment.

The competent departments of science and technology, health, and agriculture and rural affairs of the State Council shall, in conjunction with other relevant departments of the State Council, formulate, adjust and issue risk classification standards and directories of biotechnology research and development activities according to the division of duties.

Article 37  Biotechnology research and development activities shall be in compliance with the national security management norms for biotechnology research and development.

Those who engage in biotechnology research and development shall identify the class of a risk, pay close attention to any change in the risk, and take response measures in a timely manner.

Article 38  High-risk and medium-risk biotechnology research and development activities may be conducted only by the legal persons lawfully established within the territory of China with approval or after being put on record in accordance with law.

Risk assessments shall be conducted when carrying out medium-risk and high-risk biotechnology research and development activities; risk prevention and control plans and biosecurity incident emergency response plans shall be adopted to reduce risks thereof.

Article 39  The state adopts traceability management as regard important equipment and special biological factors that involve biosecurity. Purchase or import of important equipment and special biological factors included in the control lists shall be registered to ensure traceability and be reported to the relevant departments of the State Council for record.

An individual shall not buy or hold any important equipment or special biological factors which are included in the control lists.

Article 40  Clinical researches on new biomedical technologies shall, after passing the ethical review, be conducted in medical institutions with necessary and sufficient conditions. Clinical research operations on humans shall be performed by medical professionals with relevant qualifications.

Article 41  Relevant departments of the State Council shall, in accordance with law, carry out follow-up evaluations on biotechnology application activities and, if any biosecurity risk is detected, effective remedial and control measures shall be adopted in a timely manner.

Chapter V Biosecurity of Pathogenic Microorganism Laboratories

Article 42  The state strengthens biosecurity management in pathogenic microorganism laboratories by formulating uniform standards for laboratories biosecurity. Pathogenic microorganism laboratories shall follow the national biosecurity standards and requirements.

Those who engage in pathogenic microorganisms experiments shall strictly follow relevant national standards, and laboratory technical specifications as well as operating rules and procedures, and adopt preventive measures.

Article 43  The state adopts classified pathogenic microorganisms management in accordance with the infectivity of pathogenic microorganisms and the degree of harm on individuals or groups of humans and on individual animal or groups of animals.

To engage in activities of collecting, preserving and transporting the samples of highly pathogenic or suspected highly pathogenic microorganisms, the corresponding requirements shall be met and the biosecurity management norms shall be complied with. Specific procedures shall be formulated by the competent departments of health as well as agricultural and rural affairs of the State Council.

Article 44  Establishment of pathogenic microorganism laboratories shall be subject to approval or be filed for record in accordance with law.

No individual shall establish any pathogenic microorganism laboratory or engage in any pathogenic microorganism experiment.

Article 45  The state adopts pathogenic microorganism laboratory hierarchical management in accordance with the level of biosecurity protection in relation to pathogenic microorganism.

Pathogenic microorganism experiments shall be conducted in laboratories at the corresponding levels. Pathogenic microorganism experiments which should be conducted in high-level pathogenic microorganism laboratories as are specified in the national pathogenic microorganism lists shall not be conducted in low-level pathogenic microorganism laboratories. 

Article 46  To engage in a highly pathogenic or suspected highly pathogenic microorganism experiment, a high-level pathogenic microorganism laboratory shall acquire approval from the competent department of health or agricultural and rural affairs of the people's government at or above provincial level and report the circumstance of experiments to the department that approves the experiment.

Relevant pathogenic microorganism experiments shall not be conducted without approval if said pathogenic microorganisms have not yet been found or have been declared eradicated in China.

Article 47  Pathogenic microorganism laboratories shall take measures to strengthen experimental animal management,  preventing animal escape, conducting disposal of harmful materials of used experimental animals, and ensuring the traceability of experimental animals. Used experimental animals are not allowed to enter into market.

Pathogenic microorganism laboratories shall strengthen experimental waste management, dispose of waste water, waste gas and other wastes in accordance with law, and take measures to prevent pollution.

Article 48  Entities with pathogenic microbiology laboratories shall be responsible for the biosecurity management of their laboratories, adopt scientific and strict management systems, make regular inspection in terms of the implementation of relevant biosecurity regulations, and check, maintain, and update laboratory facilities, equipment and materials to ensure compliance with the national standards.

The legal representatives of the entities with pathogenic microorganism laboratories and the directors of the laboratories shall be responsible for laboratory biosecurity.

Article 49  The entities with pathogenic microorganism laboratories shall establish and improve their rules of security, and adopt measures to ensure the security of the laboratories and pathogenic microorganisms thereof.

The state shall strengthen the security of high-level pathogenic microorganism laboratories. The high-level pathogenic microorganism laboratories shall be subject to supervision and guidance from public security organs and other departments in respect of their laboratory safety and security, and take strict precautions against the leakage, loss, theft and robbery of highly pathogenic microorganisms.

The state shall establish a review and approval system for personnel entering high-level pathogenic microorganism laboratories. Personnel entering high-level pathogenic microorganism laboratories shall be subject to the approval of directors thereof. The entrance of those who may affect laboratory safety and security shall not be approved; for those who are approved to enter, security and protective measures shall be taken.

Article 50  The entities with pathogenic microorganism laboratories shall formulate emergency response plans for biosecurity incidents, organize and carry out personnel training and emergency response drills regularly. Where highly pathogenic micro-organisms are leaked, lost, stolen, or robbed of or there is any  other biosecurity incident, control measures shall be adopted in accordance with the emergency response plans and a report thereon shall be made in accordance with the regulations of the state.

Article 51  The provincial people's governments and their competent departments of health of the provinces which host pathogenic microorganism laboratories shall strengthen medical  resource allocation against infectious diseases so as to improve treatment capacity.

Article 52  Enterprises shall adopt biosecurity management on their plants involving operation of pathogenic microorganisms in accordance with relevant regulations for pathogenic microorganism laboratories and other biosecurity management norms.

Biosecurity laboratories involving operation of biotoxin, plant pests or other biology factors shall be constructed and managed with reference to the relevant regulations for pathogenic microbiological laboratories.

Chapter VI The Security of Human Genetic Resources and Biological Resources

Article 53  The state strengthens management and supervision over the activities such as the collection, preservation and utilization of, as well as the providing anyone outside China with, the human genetic resources and biological resources of China, so as to ensure the security of human genetic resources and biological resources.

The state has sovereignty over human genetic resources and biological resources of China.

Article 54  The state shall carry out investigation on human genetic resources and biological resources.

The competent department of science and technology of the State Council shall organize surveys on human genetic resources in China, and formulate the application and registration procedures for important genetic families and for the human genetic resources in specific areas.

The competent departments of the State Council for science and technology, natural resources, ecological environment, health, agriculture and rural affairs, forestry and grassland, and traditional Chinese medicine, according to the division of duties, shall organize surveys on biological resources, and formulate the application and registration procedure for important biological resources.

Article 55  The collection, preservation and utilization of, as well as providing anyone outside China with, the human genetic resources of China shall conform with ethical principles, and shall not jeopardize public health, national security, and the public interest.

Article 56  The following activities may only be conducted upon approval of the competent department of science and technology of the State Council :

(1) Collecting important genetic families or human genetic resources in specific areas in China, or collecting genetic resources of a specific species or reaching a specific quantity as prescribed by the competent department of the State Council for science and technology;

(2) Preserving the human genetic resources of China;

(3) Utilizing the human genetic resources of China to carry out international cooperation in scientific research;

(4) Delivering, mailing and taking China's human genetic resources out of the border of China.

The preceding paragraph does not apply to the collection and preservation of human genetic resources and related activities for the purpose of clinical treatment, blood collection and supply services, investigation and punishment of crimes, doping tests, and funerals.

Approvals are not required for international cooperative clinical trials carried out in clinical trial institutions for the purpose of obtaining the marketing authorization of relevant drugs and medical devices in China, which involves the use but does not involve the export of China's human genetic resources; however, the types, quantity, and purpose of use of the human genetic resources to be used shall be filed for record with the competent department of science and technology of the State Council before clinical trials are conducted.

Overseas organizations and individuals, as well as the institutions established by them or under their de facto control, shall not collect or preserve the human genetic resources of China within the territory of China, and shall not provide China's human genetic resources for anyone outside China.

Article 57  To provide information on the human genetic resources of China, or provide access to such information for overseas organizations or individuals, or the institutions established by them or under their de facto control, reports shall be submitted, along with a duplicate of the information, to the competent department of science and technology of the State Council in advance.

Article 58  Collecting, preserving, utilizing, or transporting to overseas, China's precious, endangered, or endemic species, or their genetic resources such as the individuals, organs, tissues, cells, genes available for regeneration or reproduction, shall comply with relevant laws and regulations.

Obtaining and utilizing the biological resources of China by overseas organizations or individuals, or the institutions established by them or under their de facto control shall be subject to approval in accordance with law.

Article 59  Using China's biological resources to carry out international cooperation in scientific research shall be subject to, approval in accordance with law.

Where China's human genetic resources or biological resources are used for international cooperative scientific research, it shall be guaranteed that the entities and researchers of the Chinese side  participate in the whole process of the research in a substantive manner and share the relevant rights and interests in accordance with law.

Article 60  The state strengthens prevention of and response to invasive alien species and protects biodiversity. The competent department of agriculture and rural affairs of the State Council, in collaboration with other relevant departments of the State Council, shall formulate a directory of invasive alien species and the management procedures.

The relevant departments of the State Council shall, in accordance with the division of duties, strengthen the investigation, monitoring, alerting, control, evaluation, and removal of invasive alien species as well as the related ecological restoration.

No entity or individual shall introduce, release or discard alien species without approval.