The Ministry of Science and Technology issued the Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources, which will take effect on July 1.
Cctv newsAccording to the website of the Ministry of Science and Technology, the Detailed Rules for the Implementation of the Regulations on the Management of Human Genetic Resources was deliberated and adopted at the 3rd ministerial meeting of the Ministry of Science and Technology on May 11, 2023, and is hereby promulgated and shall come into force as of July 1, 2023.
Detailed rules for the implementation of the regulations on the management of human genetic resources
Chapter I General Principles
the first In order to effectively protect and rationally utilize China’s human genetic resources, and safeguard public health, national security and social public interests, these Detailed Rules are formulated in accordance with the Biosafety Law of People’s Republic of China (PRC), Regulations of People’s Republic of China (PRC) on the Management of Human Genetic Resources (hereinafter referred to as the Regulations) and other relevant laws and administrative regulations.
the second The collection, preservation, utilization and provision of China’s human genetic resources shall abide by these detailed rules.
The information of human genetic resources mentioned in Article 2 of the Regulations includes information materials such as human genes and genome data generated by using human genetic resources.
The information of human genetic resources mentioned in the preceding paragraph does not include clinical data, imaging data, protein data and metabolic data.
Article The Ministry of Science and Technology (hereinafter referred to as the Ministry of Science and Technology) is responsible for the management of national human genetic resources investigation, administrative licensing, supervision and inspection, and administrative punishment.
The Ministry of Science and Technology entrusts relevant organizations according to law to carry out formal examination and technical review of the application materials for administrative license of human genetic resources, as well as filing, prior reporting, supervision and inspection and administrative punishment of human genetic resources.
Article 4 The Science and Technology Departments (commissions and bureaus) of provinces, autonomous regions and municipalities directly under the Central Government and the Science and Technology Bureau of Xinjiang Production and Construction Corps (hereinafter referred to as the provincial administrative department of science and technology) are responsible for the management of the following human genetic resources in this region:
(1) Supervision, inspection and daily management of human genetic resources;
(two) investigation and handling of illegal cases of human genetic resources within the scope of their functions and powers;
(three) according to the Ministry of science and technology, to carry out the investigation of human genetic resources in this region, the administrative licensing of human genetic resources, and the investigation and handling of illegal cases of human genetic resources.
Article 5 The Ministry of Science and Technology and the provincial administrative department of science and technology shall strengthen the supervision of human genetic resources, equip administrative law enforcement personnel, carry out supervision and inspection of human genetic resources activities according to their functions and powers, and perform their duties of supervision and management of human genetic resources according to law.
Article 6 The Ministry of Science and Technology employs experts in life science and technology, medicine, health, ethics, law and information security to form an expert advisory committee on human genetic resources management to provide decision-making consultation and technical support for the management of human genetic resources throughout the country.
Article 7 The Ministry of Science and Technology supports the rational use of human genetic resources to carry out scientific research, develop biomedical industry, improve diagnosis and treatment technology, strengthen management and supervision of human genetic resources, optimize examination and approval services, improve examination and approval efficiency, promote standardization of examination and approval and information disclosure, and improve management and service levels.
Chapter II General Requirements
Article 8 The collection, preservation, utilization and external provision of China’s human genetic resources shall conform to ethical principles and pass the ethical review of the ethics (review) Committee that has been filed with the relevant administrative departments. Ethical review shall comply with laws, administrative regulations and relevant provisions of the state.
Article 9 The collection, preservation, utilization and external provision of human genetic resources in China shall respect and protect the rights and interests of providers of human genetic resources, such as privacy and personal information, and obtain written informed consent according to regulations to ensure that the legitimate rights and interests of providers of human genetic resources are not infringed.
Article 10 The collection, preservation, utilization and external provision of China’s human genetic resources shall comply with the relevant requirements and technical specifications of scientific and technological activities, including but not limited to standards, norms and procedures.
Article 11 The collection and preservation of China’s human genetic resources in China or the provision of China’s human genetic resources abroad must be carried out by China’s scientific research institutions, universities, medical institutions or enterprises (hereinafter referred to as Chinese units). Domestic-funded real control institutions located in Hong Kong and Macao are regarded as Chinese units.
Overseas organizations, institutions established or actually controlled by overseas organizations and individuals (hereinafter referred to as foreign units) and overseas individuals shall not collect and preserve China’s human genetic resources within China, and shall not provide China’s human genetic resources to overseas.
Article 12 The institutions established or actually controlled by overseas organizations and individuals mentioned in Article 11 of these Rules include the following situations:
(a) overseas organizations and individuals hold or indirectly hold more than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution;
(2) Overseas organizations and individuals hold or indirectly hold less than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution, but their voting rights or other rights and interests are sufficient to dominate or exert significant influence on the decision-making and management of the institution;
(three) overseas organizations and individuals through investment relations, agreements or other arrangements, enough to dominate or exert significant influence on the decision-making and management of institutions;
(4) Other circumstances stipulated by laws, administrative regulations and rules.
Article 13 Units that collect, preserve, utilize and provide China’s human genetic resources to the outside world shall strengthen the construction of management systems, review the purposes and research plans of scientific research involving human genetic resources, and ensure the legitimate use of human genetic resources.
Article 14 To use China’s human genetic resources to carry out international scientific research cooperation, we should ensure that Chinese units and their researchers participate in the whole process and substantially, and share relevant rights and interests according to law. In the process of international scientific research cooperation, all records, data and information generated by using China’s human genetic resources should be completely open to Chinese units, and backup should be provided to Chinese units.
Article 15 The Ministry of Science and Technology has strengthened the informatization construction of human genetic resources management, established an open and unified information system platform for administrative licensing, filing and safety review of human genetic resources, provided convenience for applicants to handle administrative licensing, filing and other matters through the Internet, promoted real-time dynamic management, and realized traceability and inquiry of human genetic resources management information.
Article 16 The Ministry of Science and Technology, together with relevant departments of the State Council and provincial administrative departments of science and technology, will promote the preservation of human genetic resources by scientific research institutions, institutions of higher learning, medical institutions and enterprises in China according to laws and regulations, and promote the construction of standardized and standardized basic platforms and big data for the preservation of human genetic resources, and open them to relevant scientific research institutions, institutions of higher learning, medical institutions and enterprises in accordance with relevant state regulations.
Article 17 In response to public health emergencies and other emergencies, the Ministry of Science and Technology has established a rapid examination and approval mechanism, and the application for administrative license of human genetic resources involved in emergency response should be expedited.
The Ministry of Science and Technology shall, in accordance with the principle of unified command, high efficiency and scientific examination and approval, speed up the organization of the acceptance, evaluation and examination of the application for administrative license. The circumstances, procedures, time limits and requirements of quick approval shall be stipulated separately by the Ministry of Science and Technology.
Article 18 The Ministry of Science and Technology has formulated and timely released service guides and demonstration texts for the collection, preservation, utilization and external provision of human genetic resources in China, providing convenient and professional guidance and services for applicants to handle administrative licensing and filing of human genetic resources.
Article 19 The Ministry of Science and Technology regularly trains scientific researchers and managers of relevant departments engaged in the collection, preservation, utilization and external provision of human genetic resources, so as to enhance their legal awareness and sense of responsibility and enhance their management and service capabilities.
Article 20 The Ministry of Science and Technology and the provincial administrative department of science and technology shall establish and constantly improve the measures to prevent and control the risks of clean government, improve the supervision and restriction mechanism, and strengthen the supervision of the important links and key positions in the management of human genetic resources in their own organs.
Chapter III Investigation and Registration
Article 21 The Ministry of Science and Technology is responsible for organizing the national survey of human genetic resources. Entrusted by the Ministry of Science and Technology, the provincial administrative department of science and technology is responsible for the investigation of human genetic resources in this region.
Article 22 The national survey of human genetic resources is carried out every five years, and can be carried out according to actual needs when necessary.
Article 23 The Ministry of Science and Technology organizes experts in related fields to formulate a national work plan for the investigation of human genetic resources. The provincial administrative department of science and technology shall, after completing the investigation of human genetic resources in this region, timely summarize the survey data and information obtained and submit them to the Ministry of Science and Technology.
Article 24 On the basis of the national survey of human genetic resources, the Ministry of Science and Technology organized research on important genetic families and human genetic resources in specific areas, gradually established an inventory of important genetic families and human genetic resources in specific areas in China, and revised and improved it in a timely manner.
Article 25 The Ministry of Science and Technology is responsible for the registration of important genetic families and human genetic resources in specific areas, formulating management measures for declaration and registration, and establishing an information service platform for declaration and registration management.
Article 26 Scientific research institutions, institutions of higher learning, medical institutions and enterprises in China shall timely declare important genetic families and human genetic resources in specific areas through the registration management information service platform.
Chapter IV Administrative Licensing and Filing
Section 1 Administrative License for Collection and Preservation
Article 27 The administrative license for the collection of human genetic resources is applicable to the following activities to be carried out in China:
(1) Collection activities of human genetic resources of important genetic families. An important genetic family refers to a blood-related group with hereditary diseases, hereditary special physique or physiological characteristics, and the members of this group with hereditary diseases and hereditary special physique or physiological characteristics involve three or more generations, excluding common diseases such as hypertension, diabetes, red-green color blindness and hemophilia. Important genetic families discovered for the first time shall be declared in a timely manner in accordance with the provisions of Article 26 of these Rules.
(2) Collection activities of human genetic resources in specific areas. Human genetic resources in a specific area refer to those that have lived in isolation or special environment for a long time and have special physical characteristics or adaptive traits in physiological characteristics. Specific areas are not divided according to whether they are inhabited by ethnic minorities.
(three) for large-scale population research and the number of people more than 3000 cases of human genetic resources collection activities. Large-scale population studies include but are not limited to cohort studies, cross-sectional studies, clinical studies, and physical studies. The collection of human genetic resources involved in clinical trials to obtain the marketing license of related drugs and medical devices in China is not included, and there is no need to apply for an administrative license for the collection of human genetic resources.
Article 28 The administrative license for the preservation of human genetic resources is applicable to the activities of preserving human genetic resources in China and providing a basic platform for scientific research.
The preservation of human genetic resources refers to the act of preserving human genetic resources with legal sources in suitable environmental conditions to ensure their quality and safety for future scientific research, excluding the temporary storage for teaching purposes after laboratory testing in accordance with the requirements of laws and regulations or clinical research programs.
Article 29 Where the activities for the preservation of human genetic resources that should be applied for administrative license involve the collection of human genetic resources at the same time, the applicant only needs to apply for the administrative license for the preservation of human genetic resources, and does not need to apply for the administrative license for the collection of human genetic resources separately.
Article 30 The entity preserving human genetic resources shall, in accordance with the provisions of Article 15 of the Regulations, submit an annual report on its preservation of human genetic resources in the previous year to the Ministry of Science and Technology before January 31 of each year. The annual report shall contain the following contents:
(1) The preserved human genetic resources;
(2) Information on the source and use of human genetic resources;
(three) the implementation of the management system related to the preservation of human genetic resources;
(4) Maintenance and changes of the sites, facilities and equipment used by the entity to preserve human genetic resources;
(five) the change of the main management personnel responsible for the preservation work of this unit.
Units that preserve human genetic resources shall strengthen management to ensure that the preserved human genetic resources come from legal sources. The Ministry of Science and Technology organizes provincial administrative departments of science and technology to conduct spot checks on the preservation activities of human genetic resources preservation units in this region every year.
Section 2 Administrative Licensing and Filing of International Cooperation
Article 31 The application for the administrative license of international scientific research cooperation on human genetic resources shall pass the ethical examination of the countries (regions) where the two parties are located. If the foreign unit is really unable to provide the certification materials for the ethical review of the host country (region), it may submit the certification materials that the foreign unit approves the ethical review opinions of the Chinese unit.
Article 32 In order to obtain the marketing license of related drugs and medical devices in China, if the clinical medical and health institutions use China’s human genetic resources to carry out international cooperative clinical trials, which do not involve the exit of human genetic resources materials, approval is not required, but it shall meet one of the following circumstances, and the types, quantities and uses of human genetic resources to be used shall be filed with the Ministry of Science and Technology before the clinical trials are carried out:
(1) The collection, detection and analysis of human genetic resources and the disposal of the remaining human genetic resources are carried out in clinical medical and health institutions;
(2) The human genetic resources involved are collected in clinical medical and health institutions, and the domestic units designated by the clinical trial scheme for marketing licenses of related drugs and medical devices are tested, analyzed and the remaining samples are processed.
The clinical medical and health institutions mentioned in the preceding paragraph refer to medical institutions and disease prevention and control institutions that have filed with relevant departments in China and conducted clinical trials according to law.
In order to obtain the exploratory research part involved in the clinical trial of relevant drugs and medical devices listed in China, an administrative license for international scientific research cooperation of human genetic resources should be applied.
Article 33 The administrative license for international scientific research cooperation and the filing of international cooperative clinical trials shall be jointly applied by Chinese units and foreign units. All parties to the cooperation shall make a commitment to the authenticity, accuracy and completeness of the application materials and information.
If the international scientific research cooperation and international cooperative clinical trial of human genetic resources to be carried out involve multi-center clinical research, it shall not apply for administrative license or filing after splitting.
Article 34 To carry out multi-center clinical research, the leader unit can apply for administrative license or filing by the applicant or leader unit after passing the ethical review.
After the applicant or the leader unit has obtained the administrative license or completed the filing, the medical and health institutions participating in the clinical research will submit the certification materials of the ethical review documents of the unit or the approval documents provided by the leader unit and the commitment letter issued by the unit to the Ministry of Science and Technology, and then the international cooperative clinical research can be carried out.
Article 35 Both parties who have obtained the administrative license for international scientific research cooperation or completed the filing of international cooperative clinical trials shall jointly submit a report on cooperative research to the Ministry of Science and Technology within six months after the expiration of the effective period of the administrative license or filing. The report on cooperative research shall contain the following contents:
(a) changes in the purpose and content of the study;
(two) the implementation of the research program;
(three) the completion of the research content;
(four) the use and disposal of human genetic resources in China;
(five) all records in the research process and the recording, storage and use of data and information;
(six) the whole process and substantial participation of Chinese units and their researchers in the research and the participation of foreign units in the research;
(seven) the output, ownership and distribution of rights and interests of research results;
(eight) the ethical review involved in the study.
Section 3 Prior Report on External Provision and Open Use
Article 36 If the information of human genetic resources is provided or made available to overseas organizations, individuals and institutions established or actually controlled by them, the Chinese information owner shall report to the Ministry of Science and Technology in advance and submit information backup. To report to the Ministry of Science and Technology in advance, the following information shall be submitted:
(a) the purpose and purpose of providing or opening up the use of information on human genetic resources in China to overseas organizations and individuals and institutions established or actually controlled by them;
(2) Providing or opening up the use of China’s human genetic resources information and information backup to overseas organizations and individuals and institutions established or actually controlled by them;
(3) Basic information about overseas organizations and individuals receiving information on human genetic resources and the institutions established or actually controlled by them;
(4) Providing or opening up the potential risk assessment of the protection of human genetic resources in China to overseas organizations and individuals and their established or actually controlled institutions.
During the implementation of international scientific research cooperation that has obtained administrative license or international cooperative clinical trials that have been filed, if the Chinese unit provides the information of human genetic resources produced by the cooperation to the foreign unit, if it has been agreed in the international cooperation agreement that it will be used by both parties, it is not necessary to report in advance and submit information backup separately.
Article 37 The provision or open use of human genetic resources information to overseas organizations, individuals and institutions established or actually controlled by them may affect China’s public health, national security and social public interests, and shall pass the safety review organized by the Ministry of Science and Technology.
The situations that should be reviewed for safety include:
(1) Information on human genetic resources of important genetic families;
(2) Information on human genetic resources in specific areas;
(3) Exon sequencing and genome sequencing information resources with more than 500 cases;
(four) other circumstances that may affect China’s public health, national security and social public interests.
Article 38 The Ministry of Science and Technology shall, jointly with relevant departments, formulate safety review rules, organize experts in relevant fields to conduct safety assessment, and make a review decision according to the safety assessment opinions.
In the process of exporting human genetic resources, if the related items involve the scope of export control, they must abide by the national export control laws and regulations.
The fourth section administrative licensing, filing and prior reporting process
Article 39 If the applicant’s application materials are complete and the form meets the requirements, the Ministry of Science and Technology shall accept and issue a paper or electronic certificate stamped with a special seal and dated.
If the application materials are incomplete or inconsistent with the statutory form, the Ministry of Science and Technology shall inform the applicant of all the contents that need to be supplemented at one time within five working days from the date of receiving the formal application materials.
Article 40 The Ministry of Science and Technology shall set up an expert database and establish an expert management system according to the needs of technical review and safety review.
The Ministry of Science and Technology selects evaluation experts from the expert database in a random way, conducts technical evaluation on the application for administrative license of human genetic resources, and conducts safety assessment on the external provision or open use of human genetic resources information that should be subject to safety review. Technical review opinions and safety assessment opinions are used as reference for making administrative licensing decisions or safety review decisions.
Experts generally participate in technical review and safety review by network, and when necessary, they can use meetings, on-site surveys and other means.
Article 41 The Ministry of Science and Technology shall, within 20 working days from the date of acceptance, make an administrative licensing decision on the application for administrative licensing of human genetic resources. If an administrative licensing decision cannot be made within twenty working days, it may be extended for ten working days with the approval of the person in charge of the Ministry of Science and Technology, and the reasons for the extension shall be informed to the applicant.
Article 42 When the Ministry of Science and Technology makes a decision on administrative licensing, which requires hearing, inspection, inspection, quarantine, appraisal and technical review according to law, the time required shall not be counted within the time limit specified in Article 41 of these Detailed Rules, but the applicant shall be informed in writing of the time required.
Article 43 After the Ministry of Science and Technology makes a decision on administrative license, it shall inform the applicant in writing of the decision on administrative license and send a copy to the provincial administrative department of science and technology where the applicant is located.
A decision to grant an administrative license according to law shall be made public on the website of the Ministry of Science and Technology. If a decision is made not to grant an administrative license according to law, the reasons shall be explained, and the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article 44 After obtaining the administrative license for the collection of human genetic resources, the licensee shall apply to the Ministry of Science and Technology for changes in major matters such as the participating units, collection purposes, collection plans or collection contents.
Article 45 After obtaining the administrative license for the preservation of human genetic resources, the licensee shall apply to the Ministry of Science and Technology for changes in the purpose, scheme or content of preservation.
Article 46 After obtaining the administrative license for international scientific research cooperation on human genetic resources, in the process of international scientific research cooperation, the purpose and content of the research change, the type, quantity and use of human genetic resources involved in the research plan change, or other important matters such as the sponsor, the leader unit, the contract research organization and the third-party laboratory change, the licensee shall apply to the Ministry of Science and Technology for change.
Article 47 After obtaining the administrative license for international scientific research cooperation on human genetic resources, the licensee does not need to apply for change in any of the following circumstances, but shall submit a written explanation of the change and corresponding materials to the Ministry of Science and Technology:
The research content or research plan remains unchanged, and only involves the change that the total amount does not exceed 10% of the approved amount;
The participating units other than the cooperative units listed in Article 46 of these Rules are changed;
The name of the partner unit is changed;
The research content or research plan is changed, but it does not involve the change of the type, quantity and use of human genetic resources, or the content after the change is not beyond the approved scope.
Article 48 If the licensee applies for changes to the matters listed in Articles 44 to 46 of these Rules, the Ministry of Science and Technology shall review and make a decision on whether to approve the changes. Meet the statutory conditions and standards, the Ministry of science and technology should be changed.
Procedures such as acceptance, examination, processing time limit, decision and notification of the application for change shall be implemented with reference to the provisions of Articles 39 to 43 of these Detailed Rules on the application for administrative license.
Article 49 Before the decision on administrative license is made, if the applicant withdraws his application in writing, the Ministry of Science and Technology will terminate the examination of the application for administrative license.
Article 50 Under any of the following circumstances, the Ministry of Science and Technology may revoke the administrative license of human genetic resources at the request of interested parties or according to its functions and powers:
(a) breach of privilege, dereliction of duty to make a decision to approve the administrative license;
(two) beyond the statutory authority to make a decision to approve the administrative license;
(3) Making a decision to grant an administrative license in violation of legal procedures;
(4) granting an administrative license to an applicant who is not qualified to apply or does not meet the statutory requirements;
(five) other circumstances in which the administrative license can be revoked according to law.
If the licensee obtains the administrative license by cheating, bribery or other improper means, the Ministry of Science and Technology shall revoke it.
If the administrative license is revoked in accordance with the provisions of the preceding two paragraphs, which may cause great harm to the public interest, it shall not be revoked.
Article 51 To apply for the filing of international cooperative clinical trials, the approval documents, notices or filing and registration materials of clinical trials of the drug supervision and administration department shall be obtained in advance.
Article 52 To apply for the filing of international cooperative clinical trials, the following materials shall be submitted:
(a) the basic situation of the parties to the cooperation;
(2) The types, quantities and uses of human genetic resources involved in the study;
(3) Research plan;
(four) the approval of the ethical review of the leader unit;
(5) Other supporting materials.
Article 53 After the international cooperative clinical trial is put on record, if the types, quantities and uses of human genetic resources involved change, or if the partners, research schemes, research contents and research purposes change, the filer shall timely handle the filing changes.
If the change of research plan or research content does not involve the change of the type, quantity and use of human genetic resources, it is not necessary to go through the filing change, but a written explanation of the change and corresponding materials shall be submitted to the Ministry of Science and Technology before the change activity begins.
Article 54 After providing or opening the use of human genetic resources information to overseas organizations, individuals and institutions established or actually controlled by them, and reporting to the Ministry of Science and Technology in advance, if the purpose and recipient of the information change, it shall submit a change report to the Ministry of Science and Technology before the implementation of the change.
Article 55 If the licensee needs to extend the validity of the administrative license, it shall apply to the Ministry of Science and Technology 30 working days before the expiration of the validity of the administrative license. The Ministry of Science and Technology shall, according to the application of the licensee, make a decision on whether to approve the extension before the expiration of the validity period of the administrative license; If no decision is made within the time limit, it shall be deemed that the extension is granted.
If the filer needs to extend the validity period of filing, he shall apply to the Ministry of Science and Technology 30 working days before the expiration of the validity period of filing. The Ministry of science and technology shall complete the continuation of the record before the expiration of the validity period of the record; If it is not completed within the time limit, it shall be deemed as having completed the continuation of filing.
Chapter V Supervision and Inspection
Article 56 The Ministry of Science and Technology is responsible for the national supervision and inspection of human genetic resources, and the provincial administrative departments of science and technology are responsible for the supervision and inspection of human genetic resources in this region. The supervision and inspection items mainly include:
(a) the collection, preservation, utilization and external supply of human genetic resources, the implementation of the main responsibility of the relevant units, the establishment, improvement and implementation of relevant rules and regulations;
(2) Information on the collection, preservation and utilization of human genetic resources by the relevant units that have been approved for the human genetic resources project, and information on the exit, external provision, open use and use after leaving the country;
(three) the disposal of surplus materials, intellectual property rights and benefit sharing of human genetic resources;
(four) the authenticity of the record items of human genetic resources;
(five) other matters that the Ministry of Science and Technology or the provincial administrative department of science and technology think need supervision and inspection.
Article 57 The Ministry of Science and Technology and the provincial administrative department of science and technology shall prepare the annual supervision and inspection plan and implement the risk management of human genetic resources.
The annual supervision and inspection plan shall include inspection items, inspection methods, inspection frequency, sampling items and sampling proportion.
Article 58 The Ministry of Science and Technology and the provincial administrative department of science and technology shall increase the frequency of supervision and inspection of units that have been subjected to administrative punishment for illegal acts of human genetic resources in the past three years, that have not been corrected in time because of the management risks of human genetic resources, and that have been recorded in the relevant disciplinary list of dishonesty, and incorporate them into the annual daily supervision and inspection plan and carry out supervision and inspection. Units that have significantly improved their management system and management norms and have not committed illegal acts again may reduce the frequency of supervision and inspection in a timely manner.
Article 59 For other units other than those specified in Article 58 of these Detailed Rules, the Ministry of Science and Technology and the provincial administrative department of science and technology can randomly determine the supervision and inspection items within the scope of human genetic resources activities of the unit, and randomly select supervision and inspection personnel to carry out supervision and inspection.
Article 60 In case of serious illegal acts or temporary and unexpected tasks, as well as problems found through complaints, transfer, data monitoring, etc., the Ministry of Science and Technology and the provincial administrative department of science and technology can deploy and carry out special supervision and inspection.
Article 61 The Ministry of Science and Technology and the provincial administrative department of science and technology shall timely record and summarize the daily supervision and inspection information of human genetic resources activities, and improve the daily supervision and inspection measures.
Article 62 When it is found that the subject of supervision and inspection may have the risk of violating the relevant provisions of the Regulations, the Ministry of Science and Technology or the provincial administrative department of science and technology may conduct administrative interviews with its legal representative and principal responsible person.
Article 63 If it is found that the object under supervision and inspection may violate the provisions of the Regulations, the Ministry of Science and Technology or the provincial administrative department of science and technology shall investigate and take the following measures when necessary:
(1) Taking measures such as recording, copying, photographing and video recording according to law;
(two) to take administrative compulsory measures such as sealing up and detaining according to law;
(3) Conducting inspection, inspection, quarantine or appraisal of related articles according to law.
Article 64 The Ministry of Science and Technology or the provincial administrative department of science and technology shall implement administrative compulsory measures in accordance with the procedures stipulated in the Administrative Compulsory Law of the People’s Republic of China.
Article 65 The Ministry of Science and Technology and the provincial administrative department of science and technology shall adopt or terminate administrative compulsory measures with the approval of the person in charge of this organ.
Where compulsory measures of seizure or detention are implemented according to law, a decision and list of seizure or detention shall be made and delivered to the parties on the spot. In case of emergency, failure to seal up or detain in time may affect the investigation of the case, or there are hidden dangers that may lead to the damage and loss of human genetic resources, you can seal up or detain in advance, and fill in a decision on sealing up or detaining within 24 hours and serve it on the parties concerned.
Chapter VI Administrative Punishment
Article 66 The Ministry of Science and Technology and the provincial administrative department of science and technology shall standardize the exercise of administrative penalty discretion of human genetic resources, comprehensively consider the facts, nature, circumstances and degree of social harm of illegal acts, reasonably determine the types and extent of administrative penalties within the scope stipulated in the Regulations, ensure that the penalty is equivalent, and prevent the abnormal light and heavy.
The discretion standard of administrative punishment for human genetic resources shall be separately formulated by the Ministry of Science and Technology and announced to the public.
Article 67 Before making a decision on administrative punishment, the Ministry of Science and Technology and the provincial administrative department of science and technology shall inform the parties in writing of the contents, facts, reasons and basis of the proposed administrative punishment, and inform them that they have the right to make statements and defend themselves according to law. If the administrative penalty to be imposed falls within the scope of hearing, the party concerned shall also be informed of the right to request a hearing.
If a party exercises a statement, defend oneself or requests a hearing, it shall submit it in writing within five working days from the date of service of the notification. If it fails to do so within the time limit, it shall be deemed as giving up the above rights.
The Ministry of Science and Technology and the provincial administrative department of science and technology shall not give heavier punishment for the statements, defenses or hearings of the parties.
Article 68 The Ministry of Science and Technology or the provincial administrative department of science and technology intends to make the following administrative punishment decision, and if the party requests a hearing, it shall organize a hearing:
(1) Imposing a fine of more than 1 million yuan on a legal person or other organization or a fine of more than 100,000 yuan on a citizen;
(2) Confiscating the illegal income of legal persons and other organizations of more than 3 million yuan or confiscating the illegal income of citizens of more than 300,000 yuan;
(3) It is forbidden to engage in the activities of collecting, preserving, utilizing and providing human genetic resources in China for more than one year;
(4) Failing to accept the application for administrative license of human genetic resources for more than two years;
(5) Revoking the administrative license of human genetic resources that has been obtained;
(6) Other circumstances in which a hearing shall be organized as stipulated by laws and administrative regulations.
Article 69 Before the Ministry of Science and Technology or the provincial administrative department of science and technology makes a decision on administrative punishment of human genetic resources, the case handling institution of this department shall send the proposed administrative punishment decision and case materials to the working institution responsible for legal review of this department for legal review. No decision shall be made without legal examination or examination.
If the administrative penalty decision to be made only involves a warning, there is no need for legal review.
Article 70 After the decision on administrative punishment is made, the Ministry of Science and Technology or the provincial administrative department of science and technology shall, within seven working days, serve the decision on administrative punishment on the parties concerned or other legal recipients in accordance with relevant laws and regulations.
Article 71 The decision on administrative punishment shall be made within 90 days from the date of filing the case. If the case is complicated and the decision on administrative punishment cannot be made within 90 days, it may be extended for 90 days with the approval of the person in charge of this organ. If the case is particularly complicated and the decision on administrative punishment cannot be made after the extension, the person in charge of this organ shall decide whether to continue the extension through collective discussion. Where an extension is decided, a reasonable extension period shall be determined at the same time, but the longest extension period shall not exceed 60 days.
In the process of handling a case, the time of hearing, announcement, inspection, inspection, quarantine, appraisal, audit and suspension shall not be included in the time limit for handling a case referred to in the first paragraph of this article.
Article 72 The illegal gains stipulated in Articles 36, 39, 41, 42 and 43 of the Regulations shall be calculated by deducting appropriate reasonable expenses from all the income obtained from the implementation of illegal acts; If it is difficult to calculate, the value of human genetic resources involved in the illegal act or the amount of funds invested for human genetic resources shall be regarded as illegal income.
Article 73 In the supervision and inspection of human genetic resources or the investigation and handling of illegal cases, it is found that the relevant citizens, legal persons or other organizations do not have the storage conditions for human genetic resources, and the Ministry of Science and Technology or the provincial administrative department of science and technology shall organize the transfer of their stored human genetic resources to a unit with storage conditions for temporary storage.
Article 74 The provincial administrative department of science and technology shall, within fifteen working days from the date of making the decision on administrative punishment, submit a copy of the case handling and the decision on administrative punishment to the Ministry of Science and Technology.
Article 75 The Ministry of Science and Technology has the right to supervise the administrative punishment of human genetic resources implemented by the provincial administrative department of science and technology, and order the relevant illegal or improper acts to make corrections according to law.
Chapter VII Supplementary Provisions
Article 76 The provisions concerning the time limit in these Detailed Rules are marked as working days, excluding legal holidays; If it is not indicated as a working day, it is a natural day.
Article 77 The "above" and "not exceeding" mentioned in these Detailed Rules all include this number, while "greater than" and "insufficient" do not include this number.
Article 78 These Rules shall come into force as of July 1, 2023.