Language
- 中文
- English

Policy & News

Home page

Ministry of Science and Technology Decree No. 21 Implementing Rules for Regulations on Human Genetic Resources Management

2023-06-05

The Implementing Rules of the Regulations on Human Genetic Resources Management have been considered and adopted at the 3rd Ministerial Meeting of the Ministry of Science and Technology on 11 May 2023, and are hereby promulgated and shall come into force on 1 July 2023.

Minister Wang Zhigang

Letter dated 26 May 2023 from the Permanent Observer for Palestine to the United Nations addressed to the Secretary-General

Regulations for the Implementation of the Regulations for the Management of Human Genetic Resources

Chapter I. General provisions

Article 1 The present Implementing Rules are formulated in accordance with the Biosafety Law of the People's Republic of China, the Regulations of the People's Republic of China on the Management of Human Genetic Resources (hereinafter referred to as "the Regulations") and other relevant laws and administrative regulations in order to effectively protect and rationally utilise China's human genetic resources, and to safeguard public health, national security and the social and public interests of society.

　　Article 2 The collection, preservation, utilisation and external provision of human genetic resources in China shall comply with these Implementing Rules.

　　Human genetic resources information referred to in Article 2 of the Regulations includes human genes, genomic data and other information materials generated by the use of human genetic resources materials.

　　Human genetic resources information referred to in the preceding paragraph does not include clinical data, imaging data, protein data and metabolic data.

　　Article 3 The Ministry of Science and Technology (hereinafter referred to as the Ministry of Science and Technology) shall be responsible for the management of the national human genetic resources survey, administrative licensing, supervision and inspection, and administrative penalties.

　　The Ministry of Science and Technology shall entrust relevant organisations to carry out the formal review and technical evaluation of application materials for administrative licensing of human genetic resources, as well as the filing of human genetic resources, prior reporting, supervision and inspection, and administrative penalties, etc., according to the needs and in accordance with the law.

　　Article 4 Provinces, autonomous regions, municipalities directly under the Central Science and Technology Department (Commission, Bureau), Xinjiang Production and Construction Corps Bureau of Science and Technology (hereinafter referred to as the provincial science and technology administrative departments) is responsible for the following human genetic resources management work in the region:

　　(a) human genetic resources supervision and inspection and daily management;

　　(ii) Investigation and handling of cases of human genetic resources violations within the scope of competence;

　　(C) According to the Ministry of Science and Technology entrusted to carry out the investigation of human genetic resources in the region, human genetic resources administrative licensing, human genetic resources investigation and handling of cases of human genetic resources violations.

　　Article 5 The Ministry of Science and Technology and the provincial science and technology administrative departments shall strengthen the supervision of human genetic resources, equipped with administrative law enforcement personnel, and carry out supervision and inspection of human genetic resources activities ex officio, and fulfil the supervision and management responsibilities of human genetic resources in accordance with law.

　　Article 6 The Ministry of Science and Technology shall employ experts in life sciences and technology, medicine, health, ethics, law, information security and other fields to form an expert advisory committee on human genetic resources management, and provide decision-making advice and technical support for the management of human genetic resources nationwide.

　　Article 7 The Ministry of Science and Technology shall support the rational use of human genetic resources to carry out scientific research, develop the biomedical industry, improve diagnostic and treatment technologies, strengthen the management and supervision of human genetic resources, optimise the approval services, improve the efficiency of approval, promote the standardisation of approval and information disclosure, and enhance the management and service level.

Chapter II. General requirements

　Article 8 The collection, preservation, utilisation and external provision of human genetic resources in China shall conform to ethical principles and pass the ethical examination of the ethics (review) committee that has been filed with the relevant administrative department. Ethical review shall be conducted in compliance with laws, administrative regulations and relevant state provisions.

　　Article 9 The collection, preservation, utilisation and provision of human genetic resources in China shall respect and safeguard the rights and interests of the providers of human genetic resources, such as the right to privacy and personal information, and obtain written informed consent in accordance with the regulations, so as to ensure that the legitimate rights and interests of the providers of human genetic resources are not infringed upon.

　　Article 10 The collection, preservation, utilisation and provision of human genetic resources in China to the outside world shall comply with the relevant requirements for scientific and technological activities and technical specifications, including but not limited to standards, norms and protocols.

　　Article 11 The collection and preservation of China's human genetic resources within China's territory or the provision of China's human genetic resources to foreign countries must be carried out by China's scientific research institutes, institutions of higher learning, medical institutions or enterprises (hereinafter referred to as Chinese units). Domestically-funded institutions based in Hong Kong and Macao are regarded as Chinese units.

　　Foreign organisations and institutions established or under the actual control of foreign organisations or individuals (hereinafter referred to as foreign units) as well as foreign individuals are not allowed to collect or conserve China's human genetic resources within the territory of China, or to provide China's human genetic resources to foreign countries.

　　Article 12 The institutions established or actually controlled by foreign organisations or individuals referred to in Article 11 of these Implementing Rules shall include the following cases:

　　(a) The overseas organisation or individual holds or indirectly holds more than fifty percent of the shares, equity, voting rights, property shares or other similar interests in the institution;

　　(b) The foreign organisation or individual holds or indirectly holds less than fifty percent of the shares, equity, voting rights, property shares or other similar interests of the institution, but the voting rights or other interests enjoyed by the foreign organisation or individual are sufficient to dominate or exert significant influence on the decision-making, management and other acts of the institution;

　　(C) An overseas organisation or individual, through an investment relationship, agreement or other arrangement, is sufficient to dominate or exert significant influence over the decision-making, management and other acts of the institution;

　　(D) laws, administrative regulations, rules and other circumstances.

　　Article 13 Units that collect, preserve, utilize and make available to the outside world China's human genetic resources shall strengthen the construction of their management systems, and review such matters as the purposes and research programmes of scientific research involving human genetic resources, so as to ensure the lawful use of human genetic resources.

　　Article 14 The use of China's human genetic resources for international scientific research and cooperation shall ensure that the Chinese units and their researchers participate in the whole process of the research in a substantive manner and share the relevant rights and interests in accordance with the law. In the process of international scientific research cooperation, all records and data information generated by the use of China's human genetic resources shall be completely open to the Chinese unit, and backup shall be provided to the Chinese unit.

　　Article 15 The Ministry of Science and Technology to strengthen the construction of human genetic resources management information, the establishment of an open and unified human genetic resources administrative licensing, filing and security review of the work of the information system platform, to facilitate the applicant through the Internet for administrative licensing, filing and other matters, and to promote the real-time dynamic management, human genetic resources management information can be traced back, can be queried.

　　Article 16 The Ministry of Science and Technology, in conjunction with the relevant departments of the State Council and provincial science and technology administrative departments, shall promote China's scientific research institutes, institutions of higher learning, medical institutions and enterprises to carry out the work of preservation of human genetic resources in accordance with the law and regulations, and shall promote the construction of a standardised and regulated basic platform for the preservation of human genetic resources and the construction of big data, and open it up to the relevant scientific research institutes, institutions of higher learning, medical institutions and enterprises in accordance with the relevant state regulations.

　　Article 17 In response to public health incidents and other emergencies, the Ministry of Science and Technology to establish a rapid approval mechanism, emergency response to emergencies involving human genetic resources administrative licensing applications, should be expedited.

　　For the implementation of rapid approval of administrative licensing applications for human genetic resources, the Ministry of Science and Technology, in accordance with the principle of unified command, efficient and rapid, scientific examination and approval, to speed up the organisation of the acceptance of applications for administrative licensing, assessment, review and other work. Expedited approval of the circumstances, procedures, time limits, requirements and other matters separately provided by the Ministry of Science and Technology.

　　Article 18 The Ministry of Science and Technology shall formulate and timely release service guidelines and model texts for collecting, preserving, utilising and making available to the public the administrative licensing and filing of human genetic resources in China, so as to provide convenient and professional guidance and services for applicants to handle the administrative licensing and filing of human genetic resources.

　　Article 19 The Ministry of Science and Technology regularly conducts training for scientific researchers and managers of relevant departments engaged in the collection, preservation, utilisation and provision of human genetic resources to the outside world, so as to enhance the awareness of law and responsibility, and improve the ability of management services.

　　Article 20 The Ministry of Science and Technology and provincial science and technology administrative departments shall establish and continuously improve integrity risk prevention and control measures, improve the supervision and control mechanism, and strengthen the supervision of 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 organising and carrying out the national human genetic resources survey. Provincial science and technology administrative departments, entrusted by the Ministry of Science and Technology, shall be responsible for conducting human genetic resources surveys in their own regions.

　　Article 22 The national human genetic resources survey shall be conducted once every five years, or when necessary, according to actual needs.

　　Article 23 The Ministry of Science and Technology shall organise experts in relevant fields to formulate a national human genetic resources survey work programme. Provincial science and technology administrative departments to complete the survey of human genetic resources in the region, should be obtained after the survey data, information and timely summary and report to the Ministry of Science and Technology.

　　Article 24 The Ministry of Science and Technology shall, on the basis of the national survey of human genetic resources, organise research on important genetic families and human genetic resources in specific regions, and gradually establish a list of important genetic families and human genetic resources in specific regions in China, and revise and improve them in due course.

　　Article 25 The Ministry of Science and Technology shall be responsible for the registration of important genetic lines and human genetic resources of specific regions, formulate administrative methods for declaration and registration, and establish an information service platform for declaration and registration management.

　　Article 26 When China's scientific research institutions, institutions of higher learning, medical institutions and enterprises discover important genetic lines and region-specific human genetic resources, they shall promptly declare them through the information service platform for declaration and registration management.

Chapter IV Administrative licensing and filing

Section I. Administrative licences for collection and preservation

Article 27: Administrative licences for the collection of human genetic resources shall apply to the following activities to be carried out within the territory of China:

　　(a) Human genetic resources collection activities of important genetic families. Important genetic lineage refers to a blood-related group suffering from hereditary diseases, having hereditary special physical or physiological characteristics, and the members of the group suffering from hereditary diseases, having hereditary special physical or physiological characteristics are involved in three or more generations, with the exclusion of common diseases such as hypertension, diabetes mellitus, red-green colour blindness, haemophilia, and so on. Important genetic family lines discovered for the first time shall be declared in a timely manner in accordance with the provisions of Article 26 of these Implementing Rules.

　　(ii) Region-specific human genetic resources collection activities. Human genetic resources in specific areas refer to human genetic resources that have lived for a long time in isolation or in special environments and have special physical characteristics or adaptive traits occurring in physiological characteristics. Specific areas shall not be classified on the basis of whether they are areas inhabited by ethnic minorities.

　　(iii) Human genetic resources collection activities used for large-scale population studies with a population size of more than 3,000 cases. Large-scale population studies include, but are not limited to, cohort studies, cross-sectional studies, clinical studies, and physiological studies. Human genetic resources collection activities involved in clinical trials for obtaining marketing approval for relevant medicines and medical devices in China are not included in this list, and are not required to apply for administrative licences for human genetic resources collection.

　　Article 28 The administrative licensing of human genetic resources conservation applies to the activities of human genetic resources conservation within the territory of China, providing a basic platform for scientific research.

　　Human genetic resources conservation activities refer to the preservation of human genetic resources of legal origin under suitable environmental conditions to ensure their quality and safety for future scientific research, excluding temporary storage for teaching purposes, after laboratory testing in accordance with the requirements of laws and regulations, or as agreed in clinical research programmes.

　　Article 29 Where human genetic resources conservation activities for which administrative licences should be applied for also involve human genetic resources collection, the applicant is only required to apply for an administrative licence for human genetic resources conservation, and need not separately apply for an administrative licence for human genetic resources collection.

　　Article 30 The human genetic resources conservation unit shall, in accordance with the provisions of Article 15 of the Regulations, submit to the Ministry of Science and Technology an annual report on the conservation of human genetic resources for the previous year before 31 January each year. The annual report shall contain the following contents:

　　(a) The situation of human genetic resources in conservation;

　　(ii) information on the source and use of human genetic resources;

　　(iii) The implementation of the management system related to the conservation of human genetic resources;

　　(d) Maintenance and changes in the premises, facilities and equipment used for the conservation of human genetic resources in the unit;

　　(e) Changes in the main management personnel in charge of the conservation work of the unit.

　　Human genetic resources conservation units shall strengthen management to ensure that the sources of human genetic resources in conservation are legal. The Ministry of Science and Technology will organise provincial science and technology administrative departments to conduct annual spot checks on the conservation activities of human genetic resources conservation units in their regions.

Section II. Administrative licences and filings for international cooperation

Article 31 The application for administrative licences for international scientific research cooperation on human genetic resources shall pass the ethical examination of the respective countries (regions) of the cooperating parties. If the foreign unit is unable to provide proof of ethical examination in the country (region) where it is located, it may submit proof of recognition of the ethical examination opinion of the Chinese unit by the foreign unit.

　　Article 32 In order to obtain the relevant drugs and medical devices in our country marketing permit, the use of China's human genetic resources in clinical medical and health institutions to carry out international cooperation in clinical trials, does not involve human genetic resources materials out of the country, does not require approval, but should meet one of the following circumstances, and in the conduct of clinical trials will be used before the type of human genetic resources, the number of its use and its purpose to the Ministry of Science and Technology for the record:

　　(i) The human genetic resources involved are collected, tested, analysed and the remaining human genetic resources materials are handled within the clinical medical and health institutions;

　　(ii) The human genetic resources involved are collected within clinical medical and healthcare institutions, and the testing, analysis and remaining sample processing are carried out by the units within the territory designated by the relevant drug and medical device marketing-licensed clinical trial programme.

　　The clinical medical and healthcare institutions referred to in the preceding paragraph refer to medical institutions, disease prevention and control institutions, etc. that have been filed with the relevant authorities in China and are conducting clinical trials in accordance with the law.

　　The exploratory research part involved in the clinical trials for the purpose of obtaining permission for the relevant drugs and medical devices to be marketed in China shall apply for administrative permission for international scientific research cooperation on human genetic resources.

　　Article 33 The administrative licence for international scientific research cooperation and the record of international cooperation in clinical trials shall be jointly applied for by the Chinese and foreign units. The cooperation parties shall make a commitment to the authenticity, accuracy and completeness of the information in the application materials.

　　Proposed international scientific research cooperation in human genetic resources, international cooperation in clinical trials involving multi-centre clinical research, shall not be split to apply for administrative licensing or filing.

　　Article 34 Where a multi-centre clinical research is conducted, the sponsor or the leader of the group can apply for administrative licensing or record-keeping after the leader of the group has passed the ethical examination.

　　After the sponsor or the leader of the unit obtains the administrative permit or completes the filing, the medical and health institutions participating in the clinical research shall submit to the Ministry of Science and Technology their own ethical review approvals or certificates recognising the ethical review approvals provided by the leader of the unit, as well as the commitment issued by the unit, and then can carry out the international collaborative clinical research.

　　Article 35 To obtain administrative permission for international scientific research cooperation or complete the international cooperation in clinical trials for the record of cooperation between the two sides, should be in the administrative permission or record within six months after the expiry of the validity of the report submitted to the Ministry of Science and Technology of the situation of cooperative research. Cooperative research report shall contain the following content:

　　(i) changes in matters such as the purpose and content of the research;

　　(ii) the implementation of the research programme;

　　(iii) The completion of the research content;

　　(iv) The use and disposal of human genetic resources in China;

　　(v) All records in the course of the research and the recording, storage and use of data and information;

　　(vi) The full and substantial participation of the Chinese unit and its researchers in the research and the participation of the foreign unit in the research;

　　(vii) The output, attribution and distribution of rights and interests of the research results;

　　(viii) Ethical review of the research.

Section III. Prior reporting on access to the public, open access

Article 36 Where information on human genetic resources is provided or made available for use to organisations or individuals outside the country and the institutions they set up or actually control, the Chinese owner of the information shall make a prior report to the Ministry of Science and Technology and submit a back-up of the information. The prior report to the Ministry of Science and Technology shall submit information on the following matters:

　　(a) The purpose and use of the information on human genetic resources in China provided or made available for use to foreign organisations, individuals and institutions established or actually controlled by them;

　　(b) The provision or open use of China's human genetic resources information to foreign organisations, individuals and institutions established or actually controlled by them, and the backup of the information;

　　(c) The basic information of the overseas organisations or individuals receiving human genetic resources information and the institutions established or actually controlled by them;

　　(d) Assessment of the potential risks to the protection of human genetic resources in China of the provision or open use of human genetic resources information to foreign organisations, individuals and institutions established or actually controlled by them.

　　During the implementation of international scientific research cooperation that has obtained administrative licences or international cooperative clinical trials that have been completed for the record, if the Chinese unit provides the information on human genetic resources generated 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 to the cooperation, there is no need to separately report and submit a backup of the information in advance.

　　Article 37 Where information on human genetic resources is provided or made available for use to organisations or individuals outside China and institutions established or actually controlled by them, which may affect China's public health, national security and social public interests, the information shall pass the security review organised by the Ministry of Science and Technology.

　　Circumstances in which security review should be conducted include:

　　(i) Information on human genetic resources of important genetic families;

　　(ii) Human genetic resources information of specific regions;

　　(iii) Exome sequencing and genome sequencing information resources with a number greater than 500 cases;

　　(D) Other cases that may affect China's public health, national security and social public interests.

　　Article 38 The Ministry of Science and Technology, in conjunction with relevant departments, shall formulate rules for security review, organise experts in relevant fields to conduct security assessment, and make review decisions based on the security assessment opinions.

　　If relevant items are involved in the scope of export control in the process of exporting human genetic resources, national export control laws and regulations shall be complied with.

Section IV. Administrative licensing, filing and prior reporting processes

Article 39 Where the applicant's application materials are complete and the form complies with the regulations, the Ministry of Science and Technology shall accept and issue a paper or electronic voucher with a special seal and date.

　　Application materials are incomplete or do not meet the statutory form, the Ministry of Science and Technology shall, within five working days from the date of receipt of the formal application materials, one-time notification of the applicant needs to make corrections to all the contents.

　　Article 40 The Ministry of Science and Technology in accordance with the needs of technical evaluation and security review, the formation of expert pool and the establishment of expert management system.

　　The Ministry of Science and Technology in accordance with the random selection method from the expert database to select experts, human genetic resources administrative licensing applications for technical evaluation, security review of human genetic resources information should be provided or open use of matters for security assessment. The opinions of technical evaluation and security assessment shall be used as the reference basis for making decisions on administrative licensing or security review.

　　The experts involved in the technical review and security review generally use the network mode, if necessary, can be used in meetings, on-site investigation and other ways.

　　Article 41 The Ministry of Science and Technology shall, within twenty working days from the date of acceptance, make an administrative licensing decision on the application for administrative licensing of human genetic resources. If a decision on administrative licensing 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 applicant shall be informed of the reasons for the extension.

　　Article 42 The Ministry of Science and Technology to make administrative licensing decisions, the need for hearing, inspection, testing, quarantine, appraisal, technical review, the time required is not calculated in the implementation of the provisions of Article 41 of the time limit, but shall inform the applicant in writing of the time required.

　　Article 43 The Ministry of Science and Technology to make a decision on administrative licensing, shall inform the applicant in writing of the administrative licensing decision, and copy the applicant's location of the provincial science and technology administrative departments.

　　According to law to make a decision to grant administrative licences, shall be made public on the website of the Ministry of Science and Technology. Not administrative licensing decision shall be made according to law, shall state the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.

　　Article 44 After obtaining the administrative license for the collection of human genetic resources, the collection activities of the participating units, the collection purpose, the collection programme or the collection of content and other major changes, the licensee shall apply to the Ministry of Science and Technology to change.

　　Article 45 After obtaining the administrative license for the conservation of human genetic resources, the purpose of conservation, conservation programme or conservation content and other major changes, the licensee shall submit to the Ministry of Science and Technology to change the application.

　　Article 46 After obtaining the administrative license for international scientific research cooperation of human genetic resources, in the process of international scientific research cooperation, the research purpose, the research content changes, the research programme involves changes in the types, quantities and uses of human genetic resources, or the applicant, the team leader, the contract research organisation, the third-party laboratory and other important matters change, the licensee shall submit an application for change to the Ministry of Science and Technology. The licensee shall submit an application for change to the Ministry of Science and Technology.

　　Article 47 After obtaining the administrative licence for international scientific research cooperation on human genetic resources, in the following cases, the licensee does not need to apply for changes, but shall submit to the Ministry of Science and Technology a written description of the changes and the corresponding materials:

　　The content of the research or the research programme remains unchanged, and only the total amount involved does not exceed 10% of the approved quantity;

　　Changes in the participating units other than the cooperative units listed in Article 46 of the Implementing Rules;

　　A change in the name of the cooperative methodological unit;

　　Changes in the content of the research or the research programme, but not involving changes in the types, quantities or uses of the human genetic resources, or where the changed content does not exceed the approved scope.

　　Article 48 Where the licensee applies for changes to the matters listed in Articles 44 to 46 of the Implementing Rules, the Ministry of Science and Technology shall review and make a decision on whether to grant the changes. Where the statutory conditions and standards are met, the Ministry of Science and Technology shall make the change.

　　The procedures for acceptance, examination, processing time, decision and notification of the application for change shall be implemented with reference to the provisions of Articles 39 to 43 of these Implementing Rules concerning the application for administrative licences.

　　Article 49 Before the administrative licensing decision, the applicant withdraws the application in writing, the Ministry of Science and Technology to terminate the review of the application for administrative licensing.

　　Article 50 In any of the following cases, the Ministry of Science and Technology, at the request of the interested party or on its own authority, may revoke the administrative licensing of human genetic resources:

　　(a) Abuse of power, dereliction of duty to make a decision to grant administrative licences; (b) exceeding the legal authority to make a decision to grant administrative licences.

　　(B) exceeding the legal authority to make a decision on granting administrative licences; (C) violating the legal procedures to make a decision on granting administrative licences

　　(D) to the applicant does not have the qualifications or does not meet the statutory conditions for the granting of administrative licences; (E) may be revoked in accordance with the law to grant administrative licences.

　　(E) Other circumstances under which the administrative licence may be revoked in accordance with the law.

　　Licensee by deception, bribery and other improper means to obtain administrative licences, the Ministry of Science and Technology shall be revoked.

　　In accordance with the provisions of the first two paragraphs of the revocation of administrative licences, may cause significant damage to the public interest, not revoked.

　　Article 51 The application for international cooperation in clinical trials for the record shall obtain in advance the drug supervision and management department of the clinical trial approvals, notification or registration materials for the record.

　　Article 52 The application for filing of international cooperative clinical trials shall submit the following materials:

　　(A) the basic situation of the co-operating parties;

　　(II) The types, quantities and uses of human genetic resources involved in the use of the research;

　　(III) The research programme;

　　(iv) Ethical review approval of the team leader unit;

　　(v) Other supporting materials.

　　Article 53 If, after the completion of the filing of an international cooperative clinical trial, there is a change in the type, quantity or use of human genetic resources involved, or if there is a change in the significant matters such as the cooperation partner, the research protocol, the content of the research, or the purpose of the research, the person filing the record shall promptly apply for the filing of the change.

　　If the change of research programme or research content does not involve the change of types, quantity or use of human genetic resources, it is not necessary to apply for filing changes, but a written explanation of the change of matters and corresponding materials shall be submitted to the Ministry of Science and Technology prior to the commencement of the change of activities.

　　Article 54 If there is a change in the use or recipient of human genetic resources after the provision or open use of human genetic resources information to overseas organisations, individuals and institutions established or actually controlled by them has been reported to the Ministry of Science and Technology in advance, a report on the change of use or recipient shall be submitted to the Ministry of Science and Technology prior to the implementation of the change of the matter.

　　Article 55 If the licensee needs to extend the validity period of the administrative licence, it shall submit an application to the Ministry of Science and Technology thirty working days before the expiry of the validity period of the administrative licence. The Ministry of Science and Technology shall, on the basis of the application of the licensee, make a decision on whether to grant the continuation of the validity of the administrative licence before the expiry of the validity of the administrative licence; if the decision is not made after the expiry of the validity of the administrative licence, the continuation of the administrative licence is deemed to be granted.

　　The filer needs to extend the validity of the record, should be filed in the expiry of the validity of the record thirty working days before the application to the Ministry of Science and Technology. The Ministry of Science and Technology shall complete the continuation of the record before the expiry of the validity of the record; if not completed, the continuation of the record is deemed to have been completed.

Chapter V. Monitoring and inspection

Article 56 The Ministry of Science and Technology shall be responsible for the supervision and inspection of human genetic resources throughout the country, and the provincial science and technology administrative departments shall be responsible for the supervision and inspection of human genetic resources in their respective regions. Supervision and inspection matters mainly include:

　　(a) The implementation of the main responsibilities of the relevant units in the collection, preservation, utilisation and provision of human genetic resources to the outside world, as well as the establishment, improvement and implementation of the relevant rules and regulations;

　　(b) The collection, preservation and utilisation of human genetic resources by the relevant units of the approved human genetic resources projects, and the situation of the materials or information going out of the country, being made available to the outside world, being open for use, and being used after going out of the country;

　　(iii) Disposal of remaining materials, intellectual property rights and benefit sharing in the utilisation of human genetic resources;

　　(d) The authenticity of human genetic resources for the record;

　　(e) Other matters that the Ministry of Science and Technology or the provincial science and technology administrative department deems necessary for supervision and inspection.

　　Article 57 The Ministry of Science and Technology and the provincial science and technology administrative departments shall prepare annual supervision and inspection plans to implement risk management of human genetic resources.

　　The annual supervision and inspection plan shall include inspection matters, inspection methods, inspection frequency, and the types of sampling items, sampling ratio and other content.

　　Article 58 The Ministry of Science and Technology and the provincial science and technology administrative departments shall increase the frequency of supervision and inspection in the past three years because of human genetic resources violations have been implemented administrative penalties, the existence of human genetic resources management risks are not corrected in a timely manner, as well as the units recorded in the relevant disciplinary list of breach of trust, the Ministry of Science and Technology and the provincial science and technology administrative departments shall increase the frequency of supervision and inspection, into the annual routine supervision and inspection plan and carry out supervision and inspection. For units whose management system and management standards have been significantly improved and no further violations have occurred, the frequency of supervision and inspection may be reduced in due course.

　　Article 59 For units other than those stipulated in Article 58 of the Implementing Rules, the Ministry of Science and Technology and the provincial science and technology administrative departments may randomly determine the matters to be supervised and inspected within the scope of the unit's human genetic resources activities, and randomly assign supervisors and inspectors to carry out supervision and inspection.

　　Article 60 In case of serious violations or temporary or sudden tasks, as well as problems discovered through complaints and reports, referrals, data monitoring, etc., the Ministry of Science and Technology and the provincial science and technology administrative departments may deploy special supervision and inspection.

　　Article 61 The Ministry of Science and Technology and the provincial science and technology administrative departments shall promptly record and summarise information on the daily supervision and inspection 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 departments of science and technology may conduct administrative interviews with its legal representatives and principal officers.

　　Article 63 When it is found that the subject of supervision and inspection may have violated the provisions of the Regulations, the Ministry of Science and Technology or the provincial science and technology administrative department shall conduct investigation and may take the following measures if necessary:

　　(a) Take measures such as recording, copying, photographing and video-recording in accordance with the law;

　　(ii) Take administrative coercive measures such as seizure and detention according to law;

　　Article 64 The Ministry of Science and Technology or the provincial science and technology administrative departments to implement administrative coercive measures shall be carried out in accordance with the "People's Republic of China Administrative Compulsory Law" procedures.

　　Article 65 The Ministry of Science and Technology and the provincial science and technology administrative departments to take or lift administrative coercive measures, shall be approved by the head of the organ.

　　According to law to implement the seizure, seizure of compulsory measures shall be made and delivered on the spot to the parties involved in the seizure, seizure decision and list. If the situation is urgent, and if the seizure or impoundment does not affect the investigation or handling of the case in a timely manner, or if there is a hidden danger that it may lead to the destruction or loss of human genetic resources, the seizure or impoundment may be carried out first, and the decision on seizure or impoundment shall be made up and delivered to the party concerned within twenty-four hours.

Chapter VI. Administrative penalties

Article 66 The Ministry of Science and Technology and provincial science and technology administrative departments shall regulate the exercise of discretionary administrative penalties for human genetic resources, taking into account the facts, nature, circumstances and degree of social harm of the offence, and reasonably determining the types and ranges of administrative penalties within the scope of the Regulations to ensure that penalties are commensurate with each other and to prevent the imposition of excessively light or heavy penalties.

　　The benchmarks for administrative penalties for human genetic resources shall be formulated separately by the Ministry of Science and Technology and announced to the public.

　　Article 67 The Ministry of Science and Technology and the provincial science and technology administrative departments in the case of administrative penalties to be given before making a decision on administrative penalties, shall inform the parties in writing of the content of the proposed administrative penalties and the facts, reasons, basis, and inform the parties to enjoy the right to statement, defence in accordance with the law. Proposed administrative penalties belong to the scope of the hearing, should also inform the parties have the right to request a hearing.

　　The parties to exercise the right of statement, defence or request for a hearing, shall be from the date of delivery of the notice in writing within five working days, the late, as a waiver of the above rights.

　　The Ministry of Science and Technology and the provincial science and technology administrative departments shall not impose heavier penalties due to the statement, defence or hearing of the parties.

　　Article 68 The Ministry of Science and Technology or the provincial science and technology administrative department intends to make the following administrative penalty decision, the parties request a hearing, shall organise a hearing:

　　(A) a legal person, other organisations to impose a fine of one million yuan or more or a citizen to impose a fine of 100,000 yuan or more;

　　(ii) Confiscating more than three million yuan of the illegal income of a legal person or other organisation or confiscating more than three hundred thousand yuan of the illegal income of a citizen;

　　(C) Prohibited for more than one year from engaging in activities of collecting, preserving, utilising or making available to the outside world human genetic resources in China;

　　(D) Not to accept applications for administrative licences for human genetic resources for more than two years;

　　(E) Revocation of the obtained administrative licences of human genetic resources;

　　(F) Laws and administrative regulations shall organise hearings in other cases.

　　Article 69 The Ministry of Science and Technology or the provincial science and technology administrative departments to make administrative penalties for human genetic resources before the decision, the department's case-handling agencies shall be proposed to make administrative penalties and case materials sent to the department responsible for the legal system audit of the work of the legal system audit. No decision shall be made without legal review or if the review fails.

　　Proposed administrative penalty decision involves only a warning, do not need to carry out legal review.

　　Article 70 After the decision on administrative penalties, the Ministry of Science and Technology or the provincial science and technology administrative departments shall, within seven working days in accordance with the relevant provisions of the law, the decision on administrative penalties will be served on the parties or other legal recipients.

　　Seventy-one administrative penalty decision shall be made within ninety days from the date of filing. If the case is complicated and the administrative penalty decision cannot be made within ninety days, an extension of ninety days may be granted with the approval of the head of the organ. The case is particularly complex, the extension still can not make a decision on administrative penalties, the person in charge of the organ to collectively discuss whether to continue the extension. The decision to extend, shall also determine the extension of a reasonable period, but the maximum shall not exceed sixty days.

　　In the course of handling the case, the time for hearing, announcement, testing, inspection, quarantine, appraisal, audit and suspension shall not be counted as part of the time limit for handling the case referred to in the first paragraph of this Article.

　　Article 72 The unlawful income stipulated in Articles 36, 39, 41, 42 and 43 of the Regulations shall be calculated on the basis of all the income obtained from the commission of the unlawful act minus appropriate and reasonable expenditures; if it is difficult to calculate, the value of the human genetic resources involved in the unlawful act shall be calculated or the amount of funds invested in the human genetic resources shall be regarded as the unlawful income.

　　Article 73 In the supervision and inspection of human genetic resources or in the investigation and handling of illegal cases, if it is found that the relevant citizens, legal persons or other organisations do not have the conditions for the storage of human genetic resources, the Ministry of Science and Technology or the provincial-level science and technology administrative departments shall organise the transfer of the stored human genetic resources to the units with the conditions for the temporary storage of such resources.

　　Article 74 If the provincial science and technology administrative department imposes an administrative penalty on human genetic resources according to law, it shall, within fifteen working days from the date of the decision on the administrative penalty, report to the Ministry of Science and Technology the handling of the case and a copy of the decision on the administrative penalty.

　　Article 75 The Ministry of Science and Technology shall have the right to supervise the administrative penalties on human genetic resources imposed by the provincial administrative departments of science and technology, and order corrections to be made to the relevant unlawful or improper behaviours in accordance with the law.