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    Home > Medical News > Latest Medical News > Li Keqiang signed the order of the State Council and promulgated the regulations of the people's Republic of China on the administration of human genetic resources

    Li Keqiang signed the order of the State Council and promulgated the regulations of the people's Republic of China on the administration of human genetic resources

    • Last Update: 2019-06-11
    • Source: Internet
    • Author: User
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    Xinhua news agency, Beijing, June 10 (Xinhua) -- Premier Li Keqiang signed a State Council order and promulgated the regulations of the people's Republic of China on the management of human genetic resources (hereinafter referred to as the regulations), which will come into force on July 1, 2019 The Party Central Committee and the State Council attach great importance to the management of human genetic resources On the basis of the implementation experience of the Interim Measures for the management of human genetic resources formulated in 1998, the regulations regulate the management of human genetic resources in China from the aspects of strengthening protection, promoting rational utilization, strengthening norms, optimizing service supervision, etc First, increase protection The regulations stipulate that the State shall carry out the investigation of human genetic resources and implement the declaration and registration system for important genetic families and human genetic resources in specific areas If the institutions established or controlled by foreign organizations or foreign organizations or individuals need to use China's human genetic resources to carry out scientific research activities, they shall cooperate with Chinese units If the information of human genetic resources is provided or opened to the outside world, it shall be filed and submitted for backup If it may affect the public health, national security and social public interest of our country, it shall pass the safety review Second, promote rational utilization According to the regulations, the State supports the rational use of human genetic resources for scientific research, the development of biomedical industry, the improvement of diagnosis and treatment technology, the improvement of China's biosafety guarantee ability, and the improvement of people's health guarantee level; relevant departments should make overall planning, make rational layout, strengthen the construction of innovation system, promote the innovation and coordinated development of biotechnology and industry; and Research and development activities of resources and industrialization of achievements shall be supported in accordance with laws, administrative regulations and relevant regulations of the state The third is to strengthen the norms According to the regulations, the collection, preservation, utilization and external supply of human genetic resources in China shall not endanger the public health, national security and social public interests of China, and shall conform to the ethical principles, protect the legitimate rights and interests of resource providers, and abide by the corresponding technical specifications In carrying out biotechnology research and development activities or clinical trials, relevant laws, administrative regulations and relevant regulations of the state on the administration of biotechnology research and clinical application shall be observed In the regulations, the approval conditions and procedures for collection and preservation of China's human genetic resources and international cooperative scientific research using China's human genetic resources are clarified and improved Fourth, optimize service supervision According to the regulations, the administrative department of science and technology shall optimize and improve its services in terms of facilitating the applicants to use the Internet for examination and approval and filing matters, and strengthen the supervision and inspection of all links in the collection, preservation, utilization and external provision of human genetic resources At the same time, the relevant legal liability has been improved and the punishment has been strengthened The regulations of the people's Republic of China on the administration of human genetic resources (Order No 717 of the State Council of the people's Republic of China), which was adopted at the 41st executive meeting of the State Council on March 20, 2019, are hereby promulgated and shall come into force as of July 1, 2019 Premier Li Keqiang, May 28, 2019, Article 1 of Chapter I general provisions of the regulations of the people's Republic of China on the administration of human genetic resources, in order to effectively protect and reasonably utilize China's human genetic resources and safeguard public health, national security and social public interests, these Regulations are formulated Article 2 the term "human genetic resources" as mentioned in these Regulations includes materials and information of human genetic resources Human genetic resource materials refer to organs, tissues, cells and other genetic materials containing human genome, genes and other genetic materials The information of human genetic resources refers to the data and other information produced by human genetic resources Article 3 the collection, preservation, utilization and external supply of China's human genetic resources shall comply with these regulations In order to meet the needs of clinical diagnosis and treatment, blood collection and supply services, investigation and punishment of illegal crimes, doping testing, funeral and other activities, human body materials such as organs, tissues, cells and other related activities shall be collected and preserved in accordance with relevant laws and administrative regulations Article 4 the administrative department of science and technology under the State Council shall be responsible for the administration of human genetic resources throughout the country; other relevant departments under the State Council shall be responsible for the administration of human genetic resources within the scope of their respective functions and responsibilities The administrative departments of science and technology of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the management of human genetic resources in their respective administrative areas; other relevant departments of the people's governments of the provinces, autonomous regions and municipalities directly under the central government shall be responsible for the management of human genetic resources in their respective administrative areas within the scope of their respective functions and responsibilities Article 5 the State shall strengthen the protection of human genetic resources in China, carry out the investigation of human genetic resources, and implement the declaration and registration system for human genetic resources of important genetic families and specific areas The administrative department of science and technology under the State Council shall be responsible for organizing the investigation of human genetic resources in China and formulating specific measures for the application and registration of important genetic families and human genetic resources in specific areas Article 6 the State supports the rational use of human genetic resources for scientific research, the development of biomedical industry, the improvement of diagnosis and treatment technology, the improvement of China's ability to guarantee biosafety and the improvement of people's health Article 7 foreign organizations, individuals and the institutions they establish or actually control shall not collect or preserve China's human genetic resources within the territory of China, nor provide China's human genetic resources to foreign countries Article 8 the collection, preservation, utilization and external supply of China's human genetic resources shall not endanger China's public health, national security and social public interests Article 9 the collection, preservation, utilization and provision of China's human genetic resources to the outside world shall conform to the ethical principles and shall be subject to ethical examination in accordance with the relevant provisions of the state In order to collect, preserve, utilize and provide human genetic resources to the outside world, we should respect the privacy of human genetic resources providers, obtain their prior informed consent and protect their legitimate rights and interests The collection, preservation, utilization and external supply of China's human genetic resources shall comply with the technical specifications formulated by the administrative department of science and technology under the State Council Article 10 the sale of human genetic resources shall be prohibited The supply or use of human genetic resources for scientific research and the payment or collection of reasonable costs shall not be regarded as business Chapter II Collection and preservation Article 11 collection of human genetic resources of important genetic families or specific areas in China or collection of human genetic resources of categories and quantities specified by the administrative department of science and technology under the State Council shall meet the following conditions and be approved by the administrative department of science and technology under the State Council: (1) have the qualification of a legal person; (2) have a clear and legal collection purpose; (3) The collection plan is reasonable; (4) it has passed the ethical review; (5) it has the Department and management system responsible for the management of human genetic resources; (6) it has the places, facilities, equipment and personnel suitable for the collection activities Article 12 to collect human genetic resources in China, the provider of human genetic resources shall be informed in advance of the purpose of collection, the purpose of collection, the possible impact on health, personal privacy protection measures and the right of voluntary participation and unconditional withdrawal at any time, with the written consent of the provider of human genetic resources When informing the providers of human genetic resources of the information specified in the preceding paragraph, they must be comprehensive, complete, true and accurate, and must not conceal, mislead or deceive Article 13 The State shall strengthen the conservation of human genetic resources, accelerate the construction of standardized and standardized basic platforms for the conservation of human genetic resources and big data of human genetic resources, and provide support for the development of relevant research and development activities The State encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to carry out the preservation of human genetic resources in accordance with their own conditions and the needs of relevant research and development activities, and provides convenience for other units to carry out relevant research and development activities Article 14 the preservation of human genetic resources in China and the provision of a basic platform for scientific research shall meet the following conditions and be approved by the administrative department of science and technology under the State Council: (1) have the status of a legal person; (2) have a clear and legal purpose of preservation; (3) have a reasonable preservation plan; (4) have a legal source of human genetic resources to be preserved; (5) pass the ethical examination; (6) Having a department in charge of the management of human genetic resources and a preservation management system; (7) having places, facilities, equipment and personnel that meet the technical specifications and requirements for the preservation of human genetic resources of the state Article 15 the depository shall strengthen the management and monitoring of the preserved human genetic resources, take safety measures and formulate emergency plans to ensure the safety of preservation and use The preservation unit shall keep a complete record of the preservation of human genetic resources, properly preserve the source information and use information of human genetic resources, and ensure the legitimate use of human genetic resources The depository shall submit an annual report to the administrative department of science and technology under the State Council on the preservation of human genetic resources by the depository Article 16 the national basic platform and database for the preservation of human genetic resources shall be open to the relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with the relevant provisions of the state In order to meet the needs of public health, national security and social public interests, the state may, in accordance with law, use the human genetic resources preserved by the depository Chapter III utilization and external provision Article 17 the administrative department of science and technology under the State Council and the administrative department of science and technology under the people ' Article 18 scientific research institutions, institutions of higher learning, medical institutions and enterprises shall use human genetic resources to carry out research and development activities and to support the industrialization of their research and development activities and achievements in accordance with laws, administrative regulations and the relevant provisions of the state Article 19 The State encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises, in accordance with their own conditions and the needs of relevant research and development activities, to make use of China's human genetic resources to carry out international cooperative scientific research and improve the relevant research and development capabilities and levels Article 20 Anyone who uses China's human genetic resources to carry out biotechnology research and development activities or carry out clinical trials shall abide by the relevant laws, administrative regulations and relevant provisions of the state on biotechnology research and clinical application management Article 21 If a foreign organization or an institution established or actually controlled by a foreign organization or individual (hereinafter referred to as a foreign unit) needs to use China's human genetic resources to carry out scientific research activities, it shall abide by China's laws, administrative regulations and the relevant provisions of the state, and shall cooperate with China's scientific research institutions, institutions of higher learning, medical institutions and enterprises (hereinafter referred to as Chinese units) In the same way Article 22 the following conditions shall be met for international cooperative scientific research using China's human genetic resources, and an application shall be jointly submitted by both parties and approved by the administrative department of science and technology under the State Council: (1) there is no harm to China's public health, national security and social public interests; (2) Both parties of the cooperation are Chinese units and foreign units with legal personality, and have the foundation and ability to carry out relevant work; (3) the purpose and content of the cooperation research are clear, legal, and the duration is reasonable; (4) the cooperation research program is reasonable; (5) the human genetic resources to be used are legal, and the type and quantity are consistent with the research content; (6) Through the respective countries of both parties(
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