Administrative Regulations of the People's Republic of China on Human Genetic Resources (Revised in 2024)
Administrative Regulations of the People's Republic of China on Human Genetic Resources (Revised in 2024)
Administrative Regulations of the People's Republic of China on Human Genetic Resources (Revised in 2024)
Order of the State Council of the People's Republic of China No. 777
March 10, 2024
(Promulgated by Order of the State Council of the People's Republic of China No. 717 on May 28, 2019; and revised in accordance with the Decision of the State Council on Amending and Repealing Some Administrative Regulations on March 10, 2024)
Chapter I General Provisions
Article 1 The Regulations are formulated in order to effectively protect and reasonably utilize China's human genetic resources and safeguard public health, state security and public interests.
Article 2 For the purpose of the Regulations, human genetic resources include materials of human genetic resources and information of human genetic resources.
Materials of human genetic resources refer to the genetic materials with respect to organs, tissues, cells and so on which contain the human genome, genes and other genetic substances.
Information of human genetic resources refers to the data and other information materials generated from the utilization of materials of human genetic resources.
Article 3 Collection, preservation, utilization and external provision of China's human genetic resources shall conform to the Regulations.
Collection and preservation of organs, tissues, cells and other human substances, as well as performance of related activities, for the purpose of clinical diagnosis and treatment, blood collection and supply, investigation and handling of illegal and criminal activities, doping tests, funeral and other activities shall be subject to pertinent laws and administrative regulations.
Article 4 The health department under the State Council shall be responsible for the administration of human genetic resources nationwide; other relevant departments under the State Council shall, within the scope of their respective duties, be responsible for the relevant administration of human genetic resources.
The departments for human genetic resources under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the human genetic resources within their respective jurisdictions; other relevant departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within the scope of their respective duties, be responsible for the relevant administration of human genetic resources within their respective jurisdictions.
Article 5 The State shall strengthen the protection of China's human genetic resources, carry out the investigation of human genetic resources, and implement the declaration and registration system of human genetic resources of important genetic families and specific regions.
The health department under the State Council shall be responsible for organizing the investigation of China's human genetic resources and formulating specific measures for the declaration and registration of human genetic resources of important genetic families and specific regions.
Article 6 The State supports reasonable utilization of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnosis and treatment technologies, enhance China's capability of biosafety guarantee, and raise the guarantee level of people's health.
Article 7 Foreign organizations and individuals, as well as their established or actually controlled institutions, shall not collect or preserve China's human genetic resources within the territory of China, nor provide China's human genetic resources abroad.
Article 8 Collection, preservation, utilization and external provision of China's human genetic resources shall not endanger public health, state security or public interests in China.
Article 9 Collection, preservation, utilization and external provision of China's human genetic resources shall be based on ethical principles and be subject to ethical examination according to pertinent state regulations.
Collection, preservation, utilization and external provision of China's human genetic resources shall respect the privacy of the suppliers of human genetic resources, with their prior consents obtained and protection of their legitimate rights and interests.
Collection, preservation, utilization and external provision of China's human genetic resources shall conform to the technical specifications formulated by the health department under the State Council.
Article 10 It is prohibited to purchase or sell human genetic resources.
Lawful supply or utilization of human genetic resources for the purpose of scientific research and payment or collection of reasonable costs shall not be deemed a business.
Chapter II Collection and Preservation
Article 11 Collection of human genetic resources of China's important genetic families and specific regions, or collection of those human genetic resources in such categories and quantities as prescribed by the health department under the State Council, shall meet the following conditions and be subject to the approval of the health department under the State Council:
1. have the qualification of a legal person;
2. have specific and lawful purposes of collection;
3. have reasonable plans of collection;
4. have passed ethical examination;
5. have a department in charge of the management of human genetic resources and the management systems; and
6. have the suitable places, facilities, equipment and personnel for collection activities.
Article 12 As for collection of China's human genetic resources, prior notice shall be sent to the suppliers of human genetic resources, indicating the goals and purpose of collection, contingent effects upon health, protective measures for personal privacy, and the rights to freewill participation and unconditional withdrawal at any time, and the written consent from the suppliers of human genetic resources shall be obtained.
The information to be notified according to the preceding paragraph to the suppliers of human genetic resources must be comprehensive, complete, true and accurate, and free from concealment, misleading or cheating elements.
Article 13 The State will strengthen the preservation of human genetic resources, speed up the construction of the standardized and normative basic platform of human genetic resource preservation and the big data of human genetic resources in order to support relevant research and development activities.
The State encourages scientific research institutions, colleges and universities, medical institutions, and enterprises to carry out the preservation of human genetic resources in terms of their own conditions and the demands for relevant research & development activities, and to provide convenience to relevant research & development activities conducted by other entities.
Article 14 Whoever preserves China's human genetic resources and provides the basic platform for scientific research shall meet the following conditions and obtain the approval of the health department under the State Council:
1.
......
Order of the State Council of the People's Republic of China No. 777
March 10, 2024
(Promulgated by Order of the State Council of the People's Republic of China No. 717 on May 28, 2019; and revised in accordance with the Decision of the State Council on Amending and Repealing Some Administrative Regulations on March 10, 2024)
Chapter I General Provisions
Article 1 The Regulations are formulated in order to effectively protect and reasonably utilize China's human genetic resources and safeguard public health, state security and public interests.
Article 2 For the purpose of the Regulations, human genetic resources include materials of human genetic resources and information of human genetic resources.
Materials of human genetic resources refer to the genetic materials with respect to organs, tissues, cells and so on which contain the human genome, genes and other genetic substances.
Information of human genetic resources refers to the data and other information materials generated from the utilization of materials of human genetic resources.
Article 3 Collection, preservation, utilization and external provision of China's human genetic resources shall conform to the Regulations.
Collection and preservation of organs, tissues, cells and other human substances, as well as performance of related activities, for the purpose of clinical diagnosis and treatment, blood collection and supply, investigation and handling of illegal and criminal activities, doping tests, funeral and other activities shall be subject to pertinent laws and administrative regulations.
Article 4 The health department under the State Council shall be responsible for the administration of human genetic resources nationwide; other relevant departments under the State Council shall, within the scope of their respective duties, be responsible for the relevant administration of human genetic resources.
The departments for human genetic resources under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the human genetic resources within their respective jurisdictions; other relevant departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within the scope of their respective duties, be responsible for the relevant administration of human genetic resources within their respective jurisdictions.
Article 5 The State shall strengthen the protection of China's human genetic resources, carry out the investigation of human genetic resources, and implement the declaration and registration system of human genetic resources of important genetic families and specific regions.
The health department under the State Council shall be responsible for organizing the investigation of China's human genetic resources and formulating specific measures for the declaration and registration of human genetic resources of important genetic families and specific regions.
Article 6 The State supports reasonable utilization of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnosis and treatment technologies, enhance China's capability of biosafety guarantee, and raise the guarantee level of people's health.
Article 7 Foreign organizations and individuals, as well as their established or actually controlled institutions, shall not collect or preserve China's human genetic resources within the territory of China, nor provide China's human genetic resources abroad.
Article 8 Collection, preservation, utilization and external provision of China's human genetic resources shall not endanger public health, state security or public interests in China.
Article 9 Collection, preservation, utilization and external provision of China's human genetic resources shall be based on ethical principles and be subject to ethical examination according to pertinent state regulations.
Collection, preservation, utilization and external provision of China's human genetic resources shall respect the privacy of the suppliers of human genetic resources, with their prior consents obtained and protection of their legitimate rights and interests.
Collection, preservation, utilization and external provision of China's human genetic resources shall conform to the technical specifications formulated by the health department under the State Council.
Article 10 It is prohibited to purchase or sell human genetic resources.
Lawful supply or utilization of human genetic resources for the purpose of scientific research and payment or collection of reasonable costs shall not be deemed a business.
Chapter II Collection and Preservation
Article 11 Collection of human genetic resources of China's important genetic families and specific regions, or collection of those human genetic resources in such categories and quantities as prescribed by the health department under the State Council, shall meet the following conditions and be subject to the approval of the health department under the State Council:
1. have the qualification of a legal person;
2. have specific and lawful purposes of collection;
3. have reasonable plans of collection;
4. have passed ethical examination;
5. have a department in charge of the management of human genetic resources and the management systems; and
6. have the suitable places, facilities, equipment and personnel for collection activities.
Article 12 As for collection of China's human genetic resources, prior notice shall be sent to the suppliers of human genetic resources, indicating the goals and purpose of collection, contingent effects upon health, protective measures for personal privacy, and the rights to freewill participation and unconditional withdrawal at any time, and the written consent from the suppliers of human genetic resources shall be obtained.
The information to be notified according to the preceding paragraph to the suppliers of human genetic resources must be comprehensive, complete, true and accurate, and free from concealment, misleading or cheating elements.
Article 13 The State will strengthen the preservation of human genetic resources, speed up the construction of the standardized and normative basic platform of human genetic resource preservation and the big data of human genetic resources in order to support relevant research and development activities.
The State encourages scientific research institutions, colleges and universities, medical institutions, and enterprises to carry out the preservation of human genetic resources in terms of their own conditions and the demands for relevant research & development activities, and to provide convenience to relevant research & development activities conducted by other entities.
Article 14 Whoever preserves China's human genetic resources and provides the basic platform for scientific research shall meet the following conditions and obtain the approval of the health department under the State Council:
1.
......