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    Home > Biochemistry News > Biotechnology News > The Regulations of the People's Republic of China on the Administration of Human Genetic Resources will come into effect on July 1.

    The Regulations of the People's Republic of China on the Administration of Human Genetic Resources will come into effect on July 1.

    • Last Update: 2020-08-05
    • Source: Internet
    • Author: User
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    The Regulations of the People's Republic of China on the Administration of Human Genetic Resources have been adopted by the 41st Executive Meeting of the State Council on March 20, 2019 and are hereby promulgated and will come into effect on July 1, 2019.
    the following text: Decree No. 717 of the State Council of the People's Republic of China on the Administration of Human Genetic Resources has been adopted by the 41st Executive Meeting of the State Council on March 20, 2019 and is hereby promulgated and will come into effect on July 1, 2019.
    Premier Li Keqiang of the first chapter of Chapter 1 of 28 May 2019, Article 1 Of this Regulations are formulated for the purpose of effectively protecting and rationally utilizing China's human genetic resources and safeguarding public health, national security and public interests.
    Article 2 The human genetic resources referred to in these Regulations include materials of human genetic resources and information on human genetic resources.
    human genetic resources material refers to the human genome, genetic and other genetic materials containing organs, tissues, cells and other genetic material.
    information on human genetic resources refers to information materials such as data generated by the use of human genetic resources materials.
    Article 3 The collection, preservation, utilization and external provision of Human Genetic Resources of China shall be subject to these Regulations.
    for clinical diagnosis and treatment, blood collection services, investigation of illegal crimes, doping testing and funeral and other activities, collection, preservation of organs, tissues, cells and other human body substances and related activities, in accordance with the relevant laws and administrative regulations.
    Article 4 The administrative department of science and technology under the State Council shall be responsible for the management of human genetic resources throughout the country, and other relevant departments under the State Council shall be responsible for the management of human genetic resources within the scope of their respective responsibilities. The administrative department of science and technology of the people's government of a province, autonomous region or municipality directly under the central government of
    shall be responsible for the administration of human genetic resources in the administrative region, and other relevant departments of the people's government of a province, autonomous region or municipality directly under the Central Government shall be responsible for the management of human genetic resources in the administrative region within the scope of their respective responsibilities.
    Article 5 Countries strengthen the protection of human genetic resources in China, conduct surveys on human genetic resources, and implement a system of declaration and registration of human genetic resources in important genetic families and specific areas.
    the administrative department of science and technology under the State Council is responsible for organizing the investigation of human genetic resources in China and formulating specific measures for the declaration and registration of human genetic resources in specific genetic systems.
    Article 6 The State supports the rational use of human genetic resources for scientific research, the development of the biopharmaceutical industry, the improvement of medical and therapeutic technology, the improvement of China's biosecurity capabilities and the level of people's health security.
    Article 7 Foreign organizations, individuals and institutions established or effectively controlled shall not collect or preserve china's human genetic resources within the territory of China, nor may they provide human genetic resources of our country abroad.
    Article 8 The collection, preservation, utilization and external provision of China's human genetic resources shall not endanger China's public health, national security and public interests. Article 9 of the
    shall be in accordance with ethical principles for the collection, preservation, utilization and external provision of human genetic resources in China, and shall be subject to ethical examination in accordance with the relevant provisions of the State.
    collecting, preserving, utilizing and providing human genetic resources to the outside world, the right to privacy of the providers of human genetic resources shall be respected, their prior informed consent shall be obtained, and their legitimate rights and interests shall be protected.
    collecting, preserving, utilizing and providing china's human genetic resources to the outside world, it shall abide by the technical norms formulated by the administrative department of science and technology under the State Council. Article 10 of the
    prohibits the sale of human genetic resources.
    shall not be considered a sale in the provision or use of human genetic resources for scientific research and the payment or collection of reasonable costs.
    Chapter II Collection and Preservation Article 11 Where the collection of important genetic families of our country, human genetic resources in a particular area or the collection of human genetic resources as prescribed 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 legal personality;
    Article 12 The collection of human genetic resources in China shall be communicated in advance to the purpose of collection of human genetic resources, the purpose of collection, the possible impact on health, the protection measures for personal privacy and the right to voluntarily participate and withdraw unconditionally at any time, with the written consent of the provider of human genetic resources.
    in forming the information provided in the preceding paragraph of the provider of human genetic resources must be comprehensive, complete, true and accurate, and shall not conceal, mislead or deceive.
    Article 13 The State shall strengthen the conservation of human genetic resources, speed up the construction of standardized and standardized basic platforms for the preservation of human genetic resources and the construction of large data on 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 related research and development activities, and to facilitate other units to carry out relevant research and development activities.
    Article 14 The preservation of China's human genetic resources 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 legal personality; (2) have clear and lawful purposes for preservation; (3) the preservation scheme is reasonable; (4) the source of human genetic resources to be preserved is lawful; (5) the management system for human genetic resources and (6) the management of human resources and the management of human resources shall be subject to the requirements of the protection of human resources and the establishment of a regulatory system and the establishment of a facility.
    Article 15 The preservation unit shall strengthen the management and monitoring of the human genetic resources in storage, take safety measures, formulate emergency plans, and ensure the safety of preservation and use.
    the preservation unit shall completely record 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 preservation unit shall submit an annual report to the administrative department of science and technology under the State Council on the situation of the collection of human genetic resources by the unit.
    Article 16 The basic platform and database for the preservation of human genetic resources shall be open to relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with the relevant provisions of the State.
    for public health, national security and public interest, the state may use human genetic resources preserved by the preservation units in accordance with the law.
    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 of the people's government of a province, autonomous region or municipality directly under the Central Government shall, together with the relevant departments of the people's government at the corresponding level, make overall plans for the use of human genetic resources for scientific research and the development of the biopharmaceutical industry, rationally lay out, strengthen the construction of an innovation system, and promote innovation and coordinated development of biotechnology and industry.
    Article 18 Scientific research institutions, institutions of higher learning, medical institutions and enterprises use human genetic resources to carry out research and development activities, and support the industrialization of their research and development activities and achievements in accordance with laws, administrative regulations and relevant provisions of the State. article 19
    The State encourages scientific research institutions, institutions of higher learning, medical institutions and enterprises to use China's human genetic resources for international cooperation and scientific research and research, in accordance with their own conditions and the needs of relevant research and development activities, and to enhance the relevant research and development capabilities and levels.
    Article 20 Where a biotechnology research and development activity or a clinical trial is carried out using China's human genetic resources, it shall abide by the relevant laws, administrative regulations and relevant provisions of the State on biotechnology research and management.
    Article 21 Where a foreign organization or an institution established or actually controlled by a foreign organization or individual (hereinafter referred to as a foreign party unit) needs to use China's human genetic resources to carry out scientific research activities, it shall abide by the laws, administrative regulations and relevant provisions of the State and adopt cooperation with China's scientific research institutions, institutions of higher learning, medical institutions and enterprises (hereinafter referred to as Chinese units). article 22
    The use of China's human genetic resources for international cooperation and scientific research shall meet the following conditions and be jointly submitted by the two parties to the cooperation, and shall be 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 public interests; 33) The purpose and content of the cooperative research is clear, lawful and reasonable in terms of time; (4) the cooperative research programme is reasonable; (5) the source of the human genetic resources to be used is lawful, the type and quantity are consistent with the content of the study; (6) through the ethical examination of the respective countries (regions) of the cooperation parties; and (7) the research results belong clearly and have a reasonable and clear distribution of interests.
    in order to obtain the relevant drugs and medical devices in China's market license, in clinical institutions using China's human genetic resources for international cooperation clinical trials, not involving human genetic resources materials to leave the country, do not need to be approved.
    , however, the two parties should, before conducting clinical trials, file a record with the administrative department of science and technology under the State Council on the types, quantities and uses of human genetic resources to be used.
    the administrative department of science and technology under the State Council and the administrative department of science and technology under the people's government of a province, autonomous region or municipality directly under the Central Government to strengthen supervision over the filing of matters.
    Article 23 In the course of using China's human genetic resources for international cooperation and scientific research, if major matters such as the partner, the research purpose, the content of the study and the duration of the cooperation change, the procedures for approval of the change shall be processed. article 24
    The use of China's human genetic resources for international cooperation and scientific research shall ensure that Chinese units and their researchers participate in the whole process and substantively during the cooperation period, and that all records and data information in the course of the study are fully open to Chinese units and provide backup to Chinese units.
    using China's human genetic resources for international cooperation and scientific research, the results of patent applications, the two parties should apply jointly, the patent rights shall be shared by the partners.
    other scientific and technological achievements arising from the study, the right to use, the transfer right and the benefit-sharing method shall be agreed upon by the two parties through the cooperation agreement;
    Article 25 The two parties shall, in accordance with the principles of equality and mutual benefit, good faith, joint participation and sharing of results, sign cooperation agreements in accordance with the principles of equality and mutual benefit, good faith, joint participation and sharing of results, and make clear and specific agreements on relevant matters in accordance with the provisions of Article 24 of these Regulations. Article 26
    the use of China's human genetic resources for international cooperation and scientific research, the two partners shall jointly submit a report on cooperative research to the administrative department of science and technology under the State Council within six months after the end of international cooperation activities. article 27
    The use of China's human genetic resources for international cooperation and scientific research, or due to other special circumstances, the materials of human genetic resources in China are necessary to transport, mail or carry out of the country, they shall meet the following conditions and obtain the certificate of exit of human genetic resources materials issued 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 public interests;
    who need to transport, mail or carry materials from China's human genetic resources to carry out international scientific research using China's human genetic resources may apply separately, or they may apply separately for the export plan in the application for international cooperation scientific research, and apply together with the administrative department of science and technology under the State Council for joint examination and approval. if the
    transport, mail or carry out the materials of human genetic resources in China, the customs formalities shall be carried out on the basis of the certificate of human genetic resources materials. article 28
    The provision or open use of information on human genetic resources to foreign organizations, individuals and their institutions established or effectively controlled shall not endanger the public health, national security and public interests of our country;
    if the information on human genetic resources is provided or openly used by foreign organizations, individuals and the institutions established or actually controlled, they shall file for the record and submit a backup of the information to the administrative department of science and technology under the State Council.
    information on human genetic resources generated by international cooperation and scientific research using human genetic resources in China, which can be used by both partners.
    Chapter IV Services and Supervision Article 29 The administrative department of science and technology under the State Council shall strengthen the construction of e-government and facilitate the applicant to use the Internet for examination and approval, filing and other matters. article 30
    The administrative department of science and technology under the State Council shall formulate and promptly issue guidelines and model texts on the examination and approval of the collection, preservation, utilization and external provision of human genetic resources in China, and strengthen the guidance for applicants on such matters as examination and approval and filing.
    Article 31 The administrative department of science and technology under the State Council shall employ experts in biotechnology, medicine, health, ethics and law to form an expert evaluation committee to conduct technical review of applications for the collection and preservation of human genetic resources in China, international cooperation and scientific research, and the transportation, mailing and port exit of human genetic resources materials in China, as proposed in accordance with the provisions of these Regulations.
    review opinions as a reference for making approval decisions.
    Article 32 The administrative department of science and technology under the State Council shall, within 20 working days from the date of accepting the collection, preservation and preservation of China's human genetic resources proposed in accordance with the provisions of these Regulations, carry out international scientific research and transport, mail and carry out the materials of human genetic resources in China, make a decision on approval or non-approval; If the
    is unable to make an examination and approval decision within the prescribed time limit for special reasons, it may be extended by 10 working days with the approval of the person in charge of the science and technology administrative department under the State Council.
    Article 33 The administrative department of science and technology under the State Council and the administrative department of science and technology under the people's government of a province, autonomous region or municipality directly under the Central Government shall strengthen supervision and inspection of all aspects of the activities of collecting, preserving, utilizing and providing human genetic resources to the outside world, and if they find that the provisions of these Regulations are violated, they shall be dealt with in a timely manner and the results of inspection and treatment shall be published to the public in accordance with the law.
    Article 34 The administrative department of science and technology under the State Council and the administrative department of science and technology under the people's government of a province, autonomous region or municipality directly under the Central Government may take the following measures: (1) to enter the site for inspection; (2) to inquire about relevant personnel; (3) to consult and copy relevant information; and (4) to seize and seize the relevant human genetic resources.
    any single in Article 35.
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