Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft for Solicitation of Comments)

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Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft for Solicitation of Comments)

Chapter I: General Provisions

Chapter II: General Requirements

Chapter III: Surveys, Registration, and Data Backups

Chapter IV: Administrative Permits, Filings, and Security Reviews

Section 1: The Scope and Requirements of Administrative Permits for Collection

Section 2: The Scope and Requirements of Administrative Permits for Preservation

Section 3: The Scope and Requirements of Administrative Permits and Filings for International Cooperation

Section 4: The Scope and Requirements of Administrative Permits and Filings for Overseas Export and Provision Overseas

Section 5: Work Flow for Permitting and Filing

Section 6: Rapid Approval Mechanisms

Chapter V: Oversight and Inspections

Chapter VI: Administrative Punishments

Section 1: General Provisions

Section 2: Jurisdiction

Section 3: Opening a file

Section IV: Hearing Comments and Holding Hearings

Section 5: Review and Decision

Section 6: Enforcement

Chapter VII: Supplementary Provisions

Implementation Rules for the Regulations on the Management of Human Genetic Resources (Draft for Solicitation of Comments)

Chapter I: General Provisions

Article 1: [Legislative Basis and Goals] These Implementation Rules are drafted on the basis of laws and administrative regulations such as the PRC Bio-Security Law, the PRC Data Security Law, the PRC Administrative Permitting Law, the PRC Administrative Punishments Law, the PRC Law on Scientific and Technological Progress, the PRC Law on the Promoting the Transformation of Scientific and Technological Achievements, and the PRC Regulations on the Management of Human Genetic Resources (hereinafter "the Regulations), so as to effectively protect and reasonably utilize our nation's human genetic resources, and to preserve public health, national security, and the societal public interest.

Article 2: [Scope of Application]These Implementation Rules shall be complied with in the collection, preservation, and overseas provision of our nation's human genetic resources.

Carrying out activities related to bodily substances, such as the collection and preservation of organs, tissues, or cells, as necessary for clinical diagnosis and treatment, blood collection and supply services, the investigation of violations and crimes, testing for stimulants, funerals or other such activities is to be carried out in accordance with relevant laws and administrative regulations.

Human genetic resources include human genetic resource materials and information on human genetic resources. Human genetic resource materials refers to genetic materials such as organs, tissues, and cells, that contain the human genome, genes and other genetic materials.

Information on Human Genetic Resources refers to information materials such as data on human genes and genomes produced using human genetic materials.

Article 3: 【Central Management System】The Ministry of Science and Technology is responsible for the nation's management work such as approvals, oversight, and punishments involving human genetic resources.

Relevant public institutions may be entrusted by the Ministry of Science and Technology to take on specific support such as in permit acceptance, professional support, oversight and management, and other such areas.

Article 4: 【Local Management Systems】The science and technology departments (commissions or bureaus) of provinces, autonomous regions and directly-governed municipalities, as well as the Science and Technology Bureau of Xinjiang Production and Construction Corps, are responsible for the management of human genetic resources within their respective administrative regions:

(1) Routine management and oversight of human genetic resources;

(2) Accepting entrustment from the Ministry of Science and Technology to organize efforts such as the survey of human genetic resources in that region;

(3) Responsible for the investigation and punishment of violation cases within the scope of their duties, and organizing and carrying out investigations of violation cases in that region based on entrustment by the Ministry of Industry and Technology;

(4) Accepting entrustment by the Ministry of Science and Technology to implement matters related to human genetic resources.

Article 5: [Establishment of Law Enforcement Forces]The Ministry of Science and Technology, the science and technology departments (commissions and bureaus) of provinces, autonomous regions, and directly governed municipalities, as well as the Science and Technology Bureau of Xinjiang Production and Construction Corps shall strengthen the oversight of human genetic resources, allocate law enforcement inspectors, and, where it is necessary, they may also appoint auxiliary law enforcement personnel; to conduct oversight inspections human genetic resource activities within that administrative region or management area in accordance with their duties and perform duties to oversee and manage human genetic resources in accordance with law.

Article 6: [Mechanisms for Expert Consultation] The Ministry of Science and Technology shall appoint experts on the life sciences, technology, pharmaceuticals, health, ethics, law, and other areas to form an expert consultation committee, to provide consultation in decision making and technical support in the management of human genetic resources, and implement expert review mechanisms suited for administrative permitting.

Article 7: 【Optimization of Services】The Ministry of Science and Technology is to support the use of human genetic resources to carry out scientific research, to develop the biopharmaceuticals industry, and to improve technology for diagnostics and care; strengthening management and oversight of human genetic resources, continuing to advance the reforms of the review systems for administrative permits on human genetic resources, optimizing review mechanisms, increasing the efficiency of reviews, and advancing the regulation of reviews and disclosure of information, to raise the level of management and services.

Chapter II: General Requirements

Article 8: [Requirements of Ethics Reviews] The collection, preservation, use, or provision abroad of our nation's human genetic resources must pass an ethics review; consult provisions from the national department for health administration involving ethics reviews for scientific and medical research that can impact human life.

Article 9: [Requirements for Safeguards of Rights and Interests] The collection, preservation, use, or provision abroad of our nation's human genetic resources shall respect the privacy rights of those providing human genetic resources, acquire informed consent in advance, ensure that provider's health, and protect their lawful rights and interests.

Article 10: [Technical Compliance] The collection, preservation, use, or provision abroad of our nation's human genetic resources shall comply with relevant requirements and technical specifications for scientific research activities, including but not limited to standards, specifications, and rules.

Article 11: [Entity Qualifications] The collection, preservation, or provision abroad of our nation's human genetic resources must be carried out by a research institution, school of higher learning, medical establishment, or enterprise from our nation (hereinafter the Chinese Unit). Foreign organizations and individuals, and the entities they establish or actually control (hereinafter Foreign Units) must not collect or preserve human genetic resources within our nation's mainland territory, and must not provide our nation's human genetic resources abroad.

Article 12: [Foreign Units] "Foreign Units" refers to overseas organizations and entities established or actually controlled by overseas organizations and individuals.

Actual control as used above includes the following situations:

(1) Overseas organizations or individuals possesses or indirectly possess more than 50% of the shares, equity, voting rights, property shares, or other such rights and interests;

(2) Overseas organizations or individuals hold or indirectly hold less than 50% of the shares, equities, voting rights, property shares, or other such rights and interests, but enjoy sufficient voting rights and rights and interests in decision-making bodies to produce a major impact on resolutions, decision-making, or internal management.

(3) Overseas organizations or individuals use an agreement or other arrangements to make it so that they have a major impact on major matters such as the bodies' decision-making or business management;

(4) Other situations as determined by the Ministry of Industry and Technology.

Article 13: [Main Responsibilities of Relevant Units] Units that collect, preserve, or use our nation's human genetic resources, or provide them abroad, shall strengthen the establishment of management systems, and conduct reviews of the purpose and research plan for carrying out scientific research involving human genetic resources, to ensure that human genetic resources are used in accordance with law.

Article 14: [International Cooperation Protocols]In using our nation's human genetic resources to carry out international cooperative scientific research, both parties shall sign a cooperation agreement in accordance with the law and the principles of equal and mutual benefit, good faith, joint participation, and sharing of results, with clear and specific agreements on relevant matters.

Article 15: [Cooperative Data Sharing Filings] In using our nation's human genetic resources to carry out cooperative international scientific research, it shall be ensured that researchers from the Chinese unit substantively participate in the research throughout the entire course of the cooperation, and that all records, data, and information are made open to the Chinese unit, and that a backup copy is provided to the Chinese unit.

Article 16: [International Cooperation and Patent Sharing]Where patents are applied for research outcomes produced through collaborative scientific research using out nation's human genetic resources, the application shall be submitted by both collaborating parties together, and the patent rights shall be jointly held by the collaborating parties.

Article 17: 【Rights Sharing in International Cooperation】利用我国人类遗传资源开展国际合作科学研究产生的著作、数据、标准、工艺流程等其他科技成果,使用权、转让权和利益分享办法由双方通过合作协议约定;协议没有约定或者约定不明确的,双方都有使用的权利,但向第三方转让须经双方同意,所获收益按双方贡献大小分享;无法确定贡献大小的,由合作双方按照相同份额进行利益分享。

Article 18: [Duties of Experts] Experts are responsible for providing professional comments and suggestions on technical reviews, safety reviews, and so forth. 科技部根据技术需要组织专家对依照《条例》规定提出的采集、保藏我国人类遗传资源,开展国际合作科学研究以及将我国人类遗传资源材料运送、邮寄、携带出境的申请进行技术评审,评审意见作为作出审批决定的参考依据。 对可能影响我国公众健康、国家安全和社会公共利益的人类遗传资源信息,在对外提供前,科技部应当组织专家进行安全审查。

科技部在开展人类遗传资源日常管理、监督检查、调查登记等工作中,根据技术需要组织专家提供决策咨询和技术支撑。

Article 19: 【Incorporation of Information Technology】The Ministry of Science and Technology shall strengthen the establishment of information systems for human genetic resources, facilitating the use of the internet by declarants and applicants in handling declarations and registrations, administrative permits and filings, and so forth, advancing online and real-time dynamic management, and making it so that information on the management of human genetic resources is recorded, traceable, and available for inquiries.

Article 20: [Establishment of a Basic Platform for Preservation and Databases]科技部会同国务院有关部门及省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局推动科研机构、高等院校、医疗机构和企业依法依规开展保藏工作,推进标准化、规范化的人类遗传资源保藏基础平台和大数据建设,并依照国家有关规定向有关科研机构、高等学校、医疗机构、企业开放。

Article 21: [Government Affairs Services] 科技部应当制定并及时发布有关采集、保藏、利用、对外提供我国人类遗传资源的审批指南和示范文本,加强对申请人办理有关许可、备案等事项的指导。

Article 22: [Training Management] 科技部定期组织从事人类遗传资源采集、保藏、利用等科学研究活动有关人员以及有关部门管理人员的培训,提升法律法规意识,提高管理服务能力。

Article 23: [Communication and Exchanges] 采集、保藏、利用和对外提供我国人类遗传资源的单位在行政审批申请前、开展相关获批事项活动过程中以及相关信息备份备案等阶段,可以就重大问题与生物中心进行沟通交流。 生物中心可以根据工作需要组织与申请人进行沟通交流。

Chapter III: Surveys, Registration, and Data Backups

Article 24: [Surveying Entities] The Ministry of Science and Technology is to periodically organize national surveys of human genetic resources, and the science and technology departments (commissions and bureaus) of provinces, autonomous regions, and directly-governed municipalities, as well as the Science and Technology Bureau of the Xinjiang Production and Construction Corps, are responsible for the specific implementation of the human genetic resources surveys within their corresponding administrative regions.

Article 25: [Survey Frequency] National human genetic resource surveys are to be carried out once every five years, but may be organized and implemented as necessary based on actual needs.

Article 26: 【Survey Requirements】The Ministry of Science and Technology is to organize experts in relevant fields to formulate a work plan for national human genetic resources surveys. The science and technology departments (commissions and bureaus) of provinces, autonomous regions, and directly-governed municipalities, and the Science and Technology Bureau of the Xinjiang Production and Construction Corps shall promptly collect and aggregate the acquired survey data and information.

Article 27: 【Catalog Management of Important Human Genetic Resources】On the foundation of the national surveys of human genetic resources, the Ministry of Science and Technology is to organize and carry out research on important genetic families and the human genetic resources in specified regions, and gradually establish lists and catalogs, which are to be revised and improved at appropriate times.

Article 28: 【Registration of Important Human Genetic Resources】The Ministry of Science and Technology is responsible for efforts to register important genetic families and human genetic resources in specified regions, is to organize the drafting of measures on the management of declarations and registrations, and establish an information service platform for the management of declarations and registrations.

Article 29: 【Pro-active declaration of important human genetic resources】Our nation's research institutions, schools of higher learning, medical establishments, and enterprises that discover information on important genetic families and the human genetic resources in specified regions, should promptly conduct registration through the information platform for the management of declarations and registrations.

Article 30: 【Data Backups】 Where human genetic resource information is provided or made open for use to overseas organizations or individuals or to entities that they have established or are the actual controller of, a backup of the information shall be provided to an information backup establishment designated by the Ministry of Science and Technology, and a filing shall be made with that Ministry.

Chapter IV: Administrative Permits, Filings, and Security Reviews

Section 1: The Scope and Requirements of Administrative Permits for Collection

Article 31: [Scope of Collection]Permits for the collection of human genetic resources apply to engagement in activities collecting human genetic resources in our nation's mainland territory, including the following situations:

(1) Important genetic families. Refers to kinship groups that have hereditary illnesses or that possess special hereditary physical or physiological traits, that have 3 or more generations exhibiting the illness or traits. The collection of human genetic resources for common polygenic diseases such as hypertension and diabetes is not included in this list.

(2) Human genetic resources of specified regions. Refers to the genetic resources of groups who have lived in isolated or special environments for a long time and have adaptive characteristics in terms of physical or physiological traits. The demarcation of the specified regions is not to be based on whether they are inhabited by ethnic minorities.

(3) Collection activities for large-scale research of 3000 or more samples. Large-scale population research includes, but is not limited to cohort studies, cross-section studies, clinical research, and physiological research. Collection activities for the clinical research involved in obtaining permits to put medicines or medical instruments on the market in our nation are not included in this list.

Article 32: [Requirements for Obtaining Permits] Applications to carry out the collection of our nation's human genetic resources should comply with the following requirements:

(1) Have standing as a legal person;

(2) Have a clear and legal purpose for collection;

(3) Have a reasonable collection plan;

(4) Pass ethics review;

(5) Have departments responsible for the management of human genetic resources and management systems;

(6) Have venues, facilities, equipment, and personnel appropriate for the collection activities.

Article 33: [Requirements for Declarations of Collection] The collection of our nation's human genetic resources should be by a Chinese unit with standing as a legal person and pass review by the ethics committee in filing with the relevant management department.

Section 2: The Scope and Requirements of Administrative Permits for Preservation

Article 34: [Scope of Preservation] Permits for the preservation of human genetic resources apply to the engagement in activities in our nation's mainland territory that preserve human genetic resources and provide a foundation platform for scientific research.

"Preservation activities" refers to the saving of lawfully acquired human genetic resources in a suitable environment to ensure their quality and security for use in future scientific research, but does not include temporary storage for teaching purposes, as required by laws or regulations following laboratory testing, or as agreed to in clinical research plans.

Article 35: [Requirements for Preservation Permits] Applications to carry out the preservation of our nation's human genetic resources should comply with the following requirements:

(1) Have standing as a legal person;

(2) The purpose of preservation is clear and legal;

(3) Have a reasonable preservation plan;

(4) Have a lawful proposed source for the human genetic resources;

(5) Have passed ethics review;

(6) Have departments responsible for the management of human genetic resources and preservation management systems;

(7) Have venues, facilities, equipment, and personnel meeting the specifications and requirements for preservation of human genetic resource preservation.

Article 36: [Requirements for Preservation] The preservation of our nation's human genetic resources should be done by a Chinese unit with standing as a legal person and pass review by the ethics committee in filing with the relevant management department.

Article 37: 【Exemptions from Preservation Permitting】 Where the matters for declarations for preservation permits are met, it is not necessary to separately apply for a collection permit. The preserving unit should strengthen management to ensure that the preserved human genetic resources are collected in accordance with laws and regulations.

Article 38: [Annual Reporting]人类遗传资源的保藏单位应依据《条例》第十五条,于每年3月31日前向科技部提交上一年度本单位保藏人类遗传资源情况的年度报告,并抄送省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局。 科技部组织省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局每5年对其保藏活动进行检查。 Annual reports shall include the following content:

(1) The circumstances of preserved human genetic resources;

(2) Information on the source and use of human genetic resources;

(3) The implementation of systems for managing human genetic resources;

(4) The preservation or changes in the venues, facilities, and equipment used by the unit in preserving human genetic resources;

(5) Changes in the staff responsible for the preservation of human genetic resources in the unit.

Section 3: The Scope and Requirements of Administrative Permits and Filings for International Cooperation

Article 39: [Scope of International Cooperation] Administrative permits and filings for cooperative international academic research on human genetic resources apply to international cooperative academic research carried out by Chinese units and foreign units using our nation's human genetic resources.

Article 40: [Requirements of Permits for International Cooperation] Applications for administrative permits to use our nation's human genetic resource for cooperative international scientific research should meet the following requirements:

(1) not be harmful to our country's public health, national security or societal public interest.

(2) Both parties have the foundation and capacity to carry out the relevant work;

(3) The goals and content of the collaborative research are clear, legal and within a reasonable period;

(4) the collaborative research plan is reasonable

(5) The source of the human genetic resources is legal, and they types and volume correspond to the content.

(6) Passage of ethics reviews in the countries (regions) of both collaborators;

Where after review by the Chinese parties' ethics committee it is found that the application for cooperative scientific international research on human permits or filings do not involve major ethical issues, and there is truly no way to provide it to the foreign party for ethics review, the foreign party's ethics review may be waived.

Applications waiving the foreign party's ethics review should simultaneously satisfy the following requirements: (1) All cooperative research content in the permit or filing is to be completed within the mainland territory of our nation; (2) the content of the cooperation complies with ethical principles and does not involve major ethical issues; (3) waiving the foreign party's ethics review does not pose a risk to the subjects, or the risk is very small. Applications to wave the foreign party's ethics review should be submitted by the foreign cooperating unit. Where there are multiple domestic parties to the cooperation, the leading organization or leading group unit should submit the waiver application. 中方合作单位应由国内牵头机构或组长单位机构伦理委员会对双方合作项目的外方伦理豁免审查的理由和潜在风险进行审查。 提交外方伦理审查豁免申请,应该提供外方授权委托文件和中方合作方对伦理豁免审查的理由和潜在风险的审查结论。

(7) Clear attribution of research outputs, and clear plan for division of interests.

Article 41: [Requirements for Filings on International Cooperation] 为获得相关药品和医疗器械在我国上市许可,与中方单位合作在临床机构利用我国人类遗传资源开展国际合作临床试验、不涉及人类遗传资源材料出境的,符合以下情况需要将合作各方、拟使用的人类遗传资源种类、数量及其用途等向科技部备案,不需要审批:

(一)所涉及的人类遗传资源采集、检测、分析和剩余样本处理等在临床机构内进行的;

(二)所涉及的人类遗传资源在临床机构内采集,并由相关药品和医疗器械上市许可临床试验的临床试验方案指定的境内单位进行检测、分析和剩余样本处理的。

临床机构是指在相关部门备案,可以开展临床研究的医疗机构、疾病预防控制机构等。

为获得相关药品和医疗器械在我国上市许可的临床研究中如涉及探索性研究部分,应按照国际合作科学研究行政许可条件另行申报。

Article 42: [Declarations on Permits and Filings for International Cooperation] 国际合作行政许可、备案应由中方单位和外方单位共同申请或办理。 申报材料中,合作各方应对申报信息的真实、准确、完整作出承诺。

涉及多中心临床研究的,不得拆分行政许可申报或备案。

Article 43: [Process for Permitting and Filings for International Cooperation] 对于开展多中心临床试验的,由组长单位通过伦理审查即可提出行政许可申请或办理备案。

参与医疗机构在由组长单位取得行政许可或备案后,将本单位伦理审查认可或同意的批件及本单位签字盖章的承诺书提交至科技部,即可开展国际合作临床试验。

Article 44: [Reporting on International Cooperation] 利用我国人类遗传资源开展国际合作科学研究,合作双方应当在国际合作协议确定的合作终止日期届满后6个月内共同向科技部提交合作研究情况报告。 合作研究情况报告应当包括以下内容:

(1) Circumstances of changes to matters such as the purpose or content of research;

(2) The circumstances of the implementation of the research plan;

(3) The situation of completing research content;

(4) Circumstances of the usage of our nation's human genetic resources;

(5) Circumstances of the disposition of our nation's human genetic resources;

(6) Circumstances such as the recording, storage, and use of research data;

(7) The circumstances of both parties' participation in research, with emphasis on the Chinese unit's procedural and substantive participation;

(8) Research accomplishments;

(9) Circumstances of changes in the attribution and distribution of research results;

(10) Circumstances of research involving ethics reviews.

Section 4: The Scope and Requirements of Administrative Permits and Filings for Overseas Export and Provision Overseas

Article 45: [Requirements for Export Permits] Where in using our nation's human genetic resources to carry out cooperative international scientific research, or in other special situations, it is necessary to transport, mail, or carry our nation's human genetic resources outside the mainland territory, the following requirements shall be met and a permit shall be obtained from the Ministry of Science and Technology:

(1) not be harmful to our country's public health, national security or societal public interest.

(2) Have standing as a legal person;

(3) Have a clear foreign collaborator and reasonable uses outside the borders;

(4) The human genetic resource materials are lawfully collected or came from a lawful preservation unit;

(5) Pass ethics reviews.

Article 46: [Applications for Export Permits] 利用我国人类遗传资源开展国际合作科学研究,需要将我国人类遗传资源材料运送、邮寄、携带出境的,可以单独提出申请,也可以在开展国际合作科学研究申请中列明出境计划一并提出申请,由科技部合并审批。

将我国人类遗传资源材料运送、邮寄、携带出境的,由中方单位凭科技部人类遗传资源材料出境证明办理海关出境事宜。

Article 47: [Content of Filings for Provision Overseas] In providing or making human genetic resources available for use by foreign organizations and individuals, or the entities that they have established or actually control, a filing should be submitted to the Ministry of Science and Technology, and the filing shall include the following content:

(1) The purpose and use of the gene and genome information of our nation's human genetic resources that is being provided or made available for use abroad;

(2) The human genetic resource gene or genome information that is being provided or made available for use to the foreign unit;

(3) Information on the unit receiving information;

(4) An assessment of potential threats that might be caused to the protection of our nation's human genetic resources.

Article 48: [Security Review System] Where the provision or making human genetic resources available for use to overseas organizations and individuals, or entities they have established or are in actual control of, might impact public health, national security, and the societal public interest, it shall go through a security review organized by the Ministry of Science and Technology.

Article 49: [Scope of Security Review] Security reviews are to include the following information on overseas provision or the making open for use:

(1) Human genetic resource information on important genetic families

(1) Human genetic resource information of specified regions;

(3) Exome and genome sequencing of information resources for groups of more than 500 people;

(5) Other information that might impact our nation's public health, national security, and societal public interests.

Article 50: [Requirements for Security Reviews] In conjunction with relevant departments, the Ministry of Science and Technology is to formulate principles for security reviews, organize experts from relevant fields to conduct security review assessments, and make a decision based on the security review assessment comments that the experts put forward.

Section 5: Work Flow for Permitting and Filing

Article 51: [Method of Declaration] The Ministry of Science and Technology is to establish an open and uniform information system platform for administrative permitting, filing, and security reviews regarding human genetic resources, to facilitate declarations.

Article 52: [Applications for Permits, and their Acceptance]Applicants are to submit application materials online and submit a hardcopy printout of the online materials to the acceptance window for administrative permitting at the Ministry of Science and Technology (hereinafter the "acceptance window"). The acceptance window is to formally accept applications that have complete application materials and that conform to the prescribed format, and issue an acceptance inventory, and a dated written certificate with the dedicated seal of the administrative organ affixed.

申请人提交的申请材料不齐全、不符合法定形式的,应当在5日内一次性告知申请人必须补正的全部内容。

不予受理行政许可申请的,应当在5日内说明不受理行政许可申请的理由,并出具加盖行政机关专用印章和注明日期的书面凭证。

Article 53: [Establishing a Pool of Experts] 科技部应根据技术评审和安全审查工作需要,建立专家库,制定技术评审和安全审查要点,建立专家管理与使用及退出机制。

Article 54: 【Technical Review/Security Review]科技部对受理的申请,组织专家进行技术评审,对属于安全审查范围的情形,应组织安全审查。 科技部应当按照随机抽取方式从专家库中选取评审专家。 技术评审和安全审查一般采用网络评审方式开展,如需要也可采用会议、现场勘查等方式进行。

Article 55: [Permitting Decisions] The Ministry of Science and Technology is to deliberate the review comments and make a decision to approve or disapprove.

Article 56: [Permitting Time Periods] 科技部应当自受理之日起20日内,依照《条例》规定的采集、保藏我国人类遗传资源,开展国际合作科学研究以及将我国人类遗传资源材料运送、邮寄、携带出境申请作出批准或者不予批准的决定;不予批准的,应当说明理由。 因特殊原因无法在规定期限内作出审批决定的,经科技部分管部领导批准,可以延长10日。

Article 57: [Exceptions to Permitting Time Periods] The following times are not calculated into the relevant time limits for work:

(一)申请人补充资料、按要求核对相关申报信息等所占用的时间;

(二)组织技术评审、安全审查等所占用的时间;

(三)根据法律法规的规定中止评审审批程序的,中止评审审批程序期间所占用的时间;

(四)申请单位涉及违反《条例》行为,核查所占用的时间。

(五)听取有关部门意见所占用的时间。

Article 58: [Service] 科技部作出审批决定后,通知申请人,并抄送其所属省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局。 依法批准行政许可的,应将审批结果在科技部网站予以公开,以供公众查阅;依法作出不予行政许可的决定的,科技部应当说明理由,并告知申请人享有依法申请行政复议或者提起行政诉讼的权利。

Article 59: [Modification of Collection Permits] 在采集我国人类遗传资源活动中,涉及采集活动参与单位、采集活动期限以及采集方案变更的,应当向科技部申请变更审批。

Article 60: [Modification of Preservation Permits] Where in the course of activities to preserve our nation's human genetic resources there are changes involving the time period of the preservation activities or the preservation plan, an application to modify the plan shall be made to the Ministry of Science and Technology.

Article 61: [Major Modification of International Cooperation Permits] The circumstances in carrying out international research cooperation that require that an application to modify permits be to the Ministry of Science and Technology include:

(一)申办方、组长单位、合同研究组织、第三方实验室发生变更的;

(2) Changes occur in the purpose of the research;

(3) Changes occur in the content of the research;

(4) Changes occur in major matters such as the time period for cooperation.

重大变更申请应在变更实施前1个月进行申报。

Article 62: [Unimportant Modification of International Cooperation Permits]在利用我国人类遗传资源开展国际合作科学研究过程中,下列情形不需申请变更许可,但应向科技部提交相应材料作出说明和进行报备:

(一)研究方案不变,仅涉及例数累计不超过获批数量10%以内的变更;

(二)上述第六十一条第一款所列合作单位之外的参与单位,以及合作各方的法人单位名称发生变更的;

(三)研究方案变更,但不涉及人类遗传资源种类、数量、用途的变化或变更后的内容不超出已批准范围的,

Article 63: [Permit Applications and Revocation]申请人请求撤回行政许可申请的,科技部可以终止审核或撤销行政许可。

申请人请求撤回已生效行政许可的,科技部有权决定是否同意其撤回申请。

Article 64: [Filings and Declarations]为获得相关药品和医疗器械在我国上市目的的临床研究行政备案应在获得药品监督管理部门临床试验批件或备案后,即可进行备案。

Article 65: [Content of Filings] Filings are to include the following content:

(1) All units involved in the clinical research being filed, and the types, quantities, and uses of human genetic resources involved in the research;

(2) A research plan;

(3) The ethics review approval documents of the team leader unit.

Article 66: [Modification of Filings for International Cooperation] 已备案的国际合作事项发生涉及人类遗传资源种类、数量、用途变化的或仅涉及合作期限变化的重大事项变更,合作方应及时进行备案变更。

研究内容变化不涉及人类遗传资源种类、数量、用途变化的或仅涉及合作期限变化的,不需要重新备案,但需在变更活动开始前及时提交变更说明。

Article 67: [Modification of Data Filings] 已备案的对外提供或开放使用人类遗传资源信息用途变化等重大事项变更,合作方应及时终止备案记录、上传总结报告,并根据重大事项变更情况进行备案变更。

通过国际合作产生的数据信息应按照国际合作协议约定合作双方使用,不需单独申报数据备份备案。

Article 68: [Strengthen Oversight for Corruption Risks] 在许可和备案过程中,主管部门应建立并不断完善廉政风险防控措施,加强监管,防止以权谋私、敷衍塞责等情况发生。

Section 6: Rapid Approval Mechanisms

Article 69: [Rapid Approval] 科技部建立快速评审审批工作机制,针对发生突发公共卫生事件等突发事件,在行政应急中需要人类遗传资源行政许可的,可加快评审审批。

Article 70: [Requirements for Rapid Approval] 突发事件快速审批参照相关部门特殊/专门规定执行。

Article 71: [Process and Time Limits for Rapid Approval] 对实施快速审批流程的行政许可申请,科技部按照统一指挥、高效快速、科学审批的原则,组织加快并同步开展申请受理、评审、审批工作。 快速审批流程的情形、程序、时限、要求等由科技部另行规定。

Chapter V: Oversight and Inspections

Article 72: [Matters for Oversight Inspections]科技部负责全国人类遗传资源监督检查,各省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局负责本行政区域内监督检查。 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当就有关单位依照《条例》以及相关法律法规规章开展人类遗传资源活动的下列情况进行监督检查。 监督检查人员存在不履行职责或滥用职权、玩忽职守、徇私舞弊行为的,依法给予处分;构成犯罪的,依法追究刑事责任。

(一)人类遗传资源采集、保藏、利用、对外提供有关单位落实主体责任,建立、完善并执行有关规章制度的情况;

(二)获批人类遗传资源项目的有关单位采集、保藏、实际使用人类遗传资源的情况;

(三)样本或数据信息出境、对外提供、开放使用及出境后使用情况、剩余样本处置情况、知识产权分享与取得成果等情况;

(4) Circumstances such as the veracity of matters in the human genetic resources filing;

(五)科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局认为需要进行监督检查的其他事项。

Article 73: [Oversight Inspection Plan] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当编制年度监督检查计划,实施人类遗传资源风险管理。

年度监督检查计划应当包括检查事项、检查方式、检查频次以及抽查项目种类、抽查比例等内容。

Article 74: [Key Oversight Inspections]对近三年内曾经被科学技术行政部门实施过行政处罚、存在人类遗传资源管理风险未及时整改,以及纳入失信惩戒名单的单位应当加大监督检查频次,纳入年度日常监督检查计划并全面开展监督检查。 对于管理体系健全、管理规范、长期未发生违法行为的单位可以减少监督检查次数。

Article 75: [Random Oversight Inspections] 对本实施细则第七十三条规定以外的其他单位,科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局可以在人类遗传资源活动主体的活动范围内随机确定监督检查项目、随机选派监督检查人员实施交叉互查。

Article 76: [Special Oversight Inspections] 遇有严重违法行为或临时性、突发性任务以及通过投诉举报、转办交办、数据监测等发现的具体问题,科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局可以部署开展专项监督检查。

Article 77: [Aggregation of Oversight Inspection Information] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当及时记录、汇总人类遗传资源活动日常监督检查信息,完善日常监督检查措施。

Article 78: [Discussion of Responsibility] 被监督检查对象可能存在违反《条例》有关规定的风险时,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局可以对其法定代表人、主要负责人等进行行政约谈。

Article 79: [Measures for the Preservation of Evidence] 被监督检查对象可能存在违反《条例》有关规定的情形,在证据可能灭失或者以后难以取得的情况下,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局可以采取以下措施:

(一)根据情况及时采取记录、复制、拍照、录像等措施;

(二)依法采取查封、扣押等行政强制措施;

(三)需要检测、检验、鉴定的,送交检测、检验、鉴定。

Article 80: [Approval for Administrative Compulsion] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局采取或者解除行政强制措施,应当经本机关负责人批准。

Article 81: [Administrative Compulsion Procedures] 科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局实施行政强制措施应当依照《中华人民共和国行政强制法》规定的程序进行,并当场交付实施行政强制措施决定书和清单。

Article 82: [Punishment for Suspected Illegal Conduct] 涉嫌违法行为符合《条例》第三十九条、第四十三条规定情形,依法属于省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局行政处罚权限的,省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当及时进行行政处罚立案。

Chapter VI: Administrative Punishments

Section 1: General Provisions

Article 83: [Entities for Administrative Punishments] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局依照法定职权和程序,对自然人、法人或者其他组织违反人类遗传资源管理法律法规的行为实施行政处罚,适用本细则。 Except as otherwise specified by laws and administrative regulations.

Article 84: [Types of Administrative Punishment] The types of administrative punishment for violations with human genetic resources:

(1) Warnings;

(2) fines;

(2) Confiscation of human genetic resources that have been illegally collected or preserved, and of unlawful gains;

(4) Prohibition on engaging in activities collecting, preserving, using, or overseas provision of our nation's human genetic resources;

(5) Other administrative punishments provided for by laws and administrative regulations.

Section 2: Jurisdiction

Article 85: [Functional Jurisdiction and Territorial Jurisdiction] 人类遗传资源违法行为的行政处罚案件,由科技部或者人类遗传资源违法行为发生地的省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局管辖。

Article 86: [Transfer and Designation of Jurisdiction] 对人类遗传资源违法行为,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当受理;发现不属于自己管辖的,应当及时移送有管辖权的科学技术行政部门或者其他部门。

省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局对管辖权有异议的,应当报请科技部指定管辖。

Article 87: [Connections between the Administrative and Criminal Systems] Where human genetic resource violations constitute a crime, the Ministry of Science and Technology, the science and technology department (commission or bureau) of the province, autonomous region, or directly-governed municipality, or the Science and Technology Bureau of Xinjiang Production and Construction Corps shall transfer the case to the judicial organs; Where cases transferred to the judicial organs do not need to be pursued for criminal punishment or have criminal punishment waived, but must be given administrative punishment, the Ministry of Science and Technology. the science and technology departments (commissions and bureaus) of the province, autonomous region, and directly-governed municipality, or the Science and Technology Bureau of Xinjiang Production and Construction Corps are to take jurisdiction.

Article 88: [Transfer of Jurisdictional Authority] 科技部可以直接查处省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局管辖的案件,也可以将自己管辖的案件交由省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局管辖。 省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局可以将重大、疑难案件报请科技部管辖。

Article 89: [Entrustment of Administrative Punishing] 科技部根据需要,可以在其法定职权范围内委托省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局组织实施行政处罚。 省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局在委托范围内,以科技部名义实施行政处罚,不得再委托其他组织或者个人实施行政处罚。

科技部应当监督省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局组织实施行政处罚的行为,并对其实施行政处罚行为的后果承担法律责任。

Article 90: [Oversight of Administrative Punishments] 科技部有权对省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局违法或者不适当的行政处罚予以纠正或者撤销。

Section 3: Opening a file

Article 91: [Opening a File] 科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局发现自然人、法人或者其他组织行为涉嫌违法,依法应当给予行政处罚且有管辖权的,应当予以立案。

Article 92: [Addressing Suspected Illegal Conduct] 对有根据认为不具备人类遗传资源采集、保藏条件的,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当依法予以责令限期改正,并在15日内按照下列规定作出处理:

(一)依法对相关设备、设施、人类遗传资源予以查封、扣押。 查封、扣押人类遗传资源的,应将人类遗传资源转移至有保藏条件的相关组织临时保藏;

(二)依法给予行政处罚;

(三)经核查,有关单位经整改符合相关采集、保藏条件的,解除查封或者扣押。 实施查封、扣押,应当当场下达查封、扣押决定书和被查封、扣押的财物清单。 在不及时查封、扣押可能影响案件查处,或者存在可能导致人类遗传资源损毁灭失的隐患时,可以先行实施查封、扣押,并在24小时内补办查封、扣押决定书,送达当事人。

Article 93: [Correcting, Changing, and Re-examining Time Limits] 有关单位被责令限期改正的,应当在规定限期内完成。 因客观原因无法在规定限期内完成的,应当在进行整改的同时,于限期届满前10日内提出书面延期申请,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当在收到申请之日起5日内书面答复是否准予延期。 有关单位提出复查申请或者整改限期届满的,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当自申请或者限期届满之日起10日内进行复查,填写复查意见书,由被复查单位和科技部复查人员签名后存档。 逾期未整改或者整改不合格的,科技部应当依法给予行政处罚。

Article 94: [Recusal of Law Enforcement Personnel] 对已经立案的案件,由立案审批人指定科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局两名以上具有执法资格的执法人员进行调查。

有下列情形之一的,承办案件的执法人员应当回避:

(一)本人是本案的当事人或者当事人的近亲属的;

(2) they, or close family members, have an interest in the case;

(三)与本人有其他利害关系,可能影响案件的公正处理的。

科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局承办案件执法人员的回避,由本机关负责人决定。 回避决定作出之前,承办案件的科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局执法人员不得擅自停止对案件的调查。

Article 95: [Investigation Procedures] Notes shall be kept of questioning or inspections. 笔录应当记载时间、地点、询问和检查情况,并由被询问人、被检查单位和执法人员签名或者盖章;被询问人、被检查单位要求补正的,应当允许。 被询问人或者被检查单位拒绝签名或者盖章的,执法人员应当在笔录上注明原因并签名。

Article 96: [Collecting and Gathering Evidence]执法人员应当收集、调取与案件有关的原始凭证作为证据。 调取原始凭证确有困难的,可以复制,并由出具证据的人员签名或者单位盖章。

Article 97: Methods of Collecting Evidence] 执法人员在收集证据时,可以采取抽样取证的方法;在证据可能灭失或者以后难以取得的情况下,经本机关负责人批准,可以先行登记保存,并应当在7日内作出处理决定:

(一)违法事实成立依法应当没收的,作出行政处罚决定,予以没收;依法应当扣留或者封存的,予以扣留或者封存;

(二)违法事实不成立,或者依法不应当予以没收、扣留、封存的,解除登记保存。

Article 98: [Investigative Inspection Procedures]执法人员对与案件有关的物品、场所进行勘验检查时,应当通知当事人到场,制作勘验笔录,并由当事人核对无误后签名或者盖章。 当事人拒绝到场的,可以邀请在场的其他人员作证,并在勘验笔录中注明;也可以采用录音、录像等方式记录有关物品、场所的情况后,再进行勘验检查。

Section IV: Hearing Comments and Holding Hearings

Article 99: [Advance Notice of Administrative Punishment] 行政处罚决定作出前,科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当向当事人送达行政处罚事先告知书,载明下列内容:

(一)拟作出行政处罚的事实、理由和依据;

(二)拟作出的行政处罚决定;

(三)当事人依法享有陈述和申辩的权利;

(四)符合法律法规所规定条件的,当事人享有要求举行听证的权利。

Article 100: [Parties' Rights to Hear Evidence, Make Statements, and Make a Defense] 当事人要求听证的,应当在收到告知书后5日内以书面形式向科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局提出听证要求。 当事人逾期未提出书面听证要求的,视为放弃听证权利。

当事人不要求听证的,也可以在告知书送达后15日内向科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局提出书面陈述和申辩。 科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局对当事人提出的事实、理由和证据,应当进行复核;当事人提出的事实、理由和证据成立的,应当采纳。

科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局不得因当事人陈述或者申辩而加重处罚。

科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局对已经送达的行政处罚事先告知书认定的主要事实、理由、依据或者拟处罚决定作出调整的,应当重新向当事人送达行政处罚事先告知书,但根据当事人的陈述和申辩意见,作出对当事人有利变更的除外。

Article 101: [Parties' Right to Access the Evidence] 当事人收到行政处罚事先告知书后,可以申请查阅涉及本人行政处罚事项的证据,但涉及国家秘密、他人的商业秘密和个人隐私的内容除外。

Article 102: [Scope of Hearings] 科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局拟对当事人依法作出下述一项或一项以上行政处罚决定,当事人要求举行听证的,应当组织听证:
(一)没收违法所得100万元以上;
(二)罚款500万元以上;
(三)禁止从事采集、保藏、利用、对外提供我国人类遗传资源的活动;
(四)法律、法规和规章规定的应当举行听证的其他情形。

Article 103: [Organization of Hearings] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局收到当事人的听证要求后,应当进行审查,对符合规定的,应当及时组织听证,并应当在举行听证7日前书面通知当事人举行听证的时间、地点等有关事宜;同时通知案件调查人员。

当事人应当按期参加听证。 当事人未按期参加听证的,视为放弃听证权利。

Article 104: [Methods for Parties' Participation in Hearings] 当事人委托代理人参加听证的,应当在举行听证前向科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局提交授权委托书。 授权委托书应当具体写明授权范围和权限。

Article 105: [Parties' Rights and Obligations in Hearings] 当事人在听证中的权利和义务:

(一)有权对案件涉及的事实、适用法律及有关情况进行陈述和申辩;

(二)有权对案件调查人员提出的证据进行质证和提出新的证据;

(三)如实陈述案件事实和回答提问;

(四)遵守听证纪律,服从听证主持人的要求。

Article 106: [Procedures for Hearings] Hearings shall be conducted according to the following procedures:

(一)听证开始前,书记员应当查明案件当事人及其代理人、案件调查人员等听证参加人是否到场,并宣布听证纪律;

(二)听证主持人核对听证参加人,宣布出席听证的听证员、书记员和案件调查人员名单,告知听证参加人在听证中的权利义务,询问案件当事人是否申请回避;

(三)听证主持人宣布听证开始,宣布案由;

(四)案件调查人员提出当事人违法的具体事实、证据和行政处罚建议、法律依据;

(五)当事人及其代理人陈述申辩意见并质证,提出为自己辩解的证据;

(六)经听证主持人允许,当事人及其代理人和案件调查人员双方可以就案件事实相互进行质证,并均可向证人、鉴定人发问;

(七)主持人、听证员提问;

(八)当事人作补充陈述;

(九)听证主持人宣布听证结束。

Article 107: [Powers of the Moderator at a Hearing] 听证主持人在听证中有权对听证参加人违反听证会场纪律的行为予以制止;对不听制止的,可以责令其退出听证会场。

Article 108: [Submission of Materials] 听证结束,案件当事人及其代理人应将申辩材料及有关证据提交听证会。

Article 109: [Hearing Records] 书记员应当将听证活动记入笔录。 听证笔录应当交由案件当事人及其代理人、本案调查人员、证人及其他有关人员确认无误后签字或者盖章。 认为有错误的,可以要求补充或者改正。 没有错误又拒绝签名或者盖章的,由书记员在听证笔录上记明情况。

Article 110: [Hearing Panel] 听证结束后,听证员应当进行合议,案件调查人员、案件审理人员可以参加合议并发表意见。 案件合议情况应当制作纪要,并由听证员签名。

Article 111: [Hearings Do Not Impact the Parties' Remedies for Punishment Decisions] 听证的举行,不影响行政处罚决定作出后当事人申请行政复议、提起行政诉讼的权利。

Section 5: Review and Decision

Article 112: [Circumstances that Shall Be Considered in the Exercise of Discretion] 科技部和省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局行使行政处罚权必须符合立法目的,并综合考虑以下情节:

(1) The harm and impact caused by the violations;

(2) Whether the parties are at fault and the degree of fault;

(3) The specific means and methods of the violation;

(4) The specific subjects harmed by the violations;

(5) Whether it is the first violation by the party;

(6) The party's attitude in correcting the violation, the corrective measures employed, and their efficacy.

Where for the same type of violation the circumstances are the same or similar and the degree of harm to society is equivalent, the type and range of administrative punishment shall be equivelant.

Article 113: [Legal Review]案件调查终结后,负责承办案件的科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局执法人员应当填写案件处理呈批表,连同有关证据材料一并报本部门负责人审批。 在本机关负责人作出行政处罚的决定之前,应当由负责案件办理部门送法制部门进行法制审核。

Article 114: [Service of Punishment Decision Documents] 行政处罚决定书作出后,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当在7日内依照民事诉讼法的有关规定,将行政处罚决定书送达当事人或者其他的法定受送达人:

(一)送达必须有送达回执,由受送达人在送达回执上注明收到日期,签名或者盖章;

(二)送达应当直接送交受送达人。 受送达人是公民的,本人不在的,交由其同住成年家属签收,并在行政处罚决定书送达回执的备注栏内注明与受送达人的关系;

(三)受送达人是法人或者其他组织的,应当由法人的法定代表人、其他组织的主要负责人或者该法人、组织负责收件的人签收;

(四)受送达人指定代收人的,交代收人签收并注明受当事人委托的情况;

(五)直接送达确有困难的,可以挂号邮寄送达,也可以委托当地科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局代为送达,代为送达的科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局收到文书后,必须立即交受送达人签收;

(六)当事人或者他的同住成年家属拒绝签收的,送达人应当邀请有关基层组织的代表或者有关人员到场,注明情况,在行政处罚决定书送达回执上注明拒收的事由和日期,由送达人、见证人签名或者盖章,将文书留在当事人的收发部门或者住所,即视为送达;

(七)受送达人下落不明,或者用以上方式无法送达的,可以公告送达,自公告发布之日起经过60日,即视为送达。 公告送达,应当在案卷中注明原因和经过。 科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局送达其他行政处罚执法文书,按照前款规定办理。

Article 115: [Time Limits for Making Punishment Decisions] 行政处罚案件应当自立案之日起60日内作出行政处罚决定;由于客观原因不能完成的,经办理案件的科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局负责人同意,可以延长,但不得超过90日;特殊情况需进一步延长的,经科技部批准,可延长至180日。

Article 116: [Combining Punishments]有关单位及有关人员触犯不同的法律、行政法规、部门规章规定,有两个以上应当给予行政处罚的违法行为的,科技部或者省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局应当适用不同的规定,分别裁量,合并处罚。

Article 117: [Methods for Calculating Unlawful Gains] 违法采集、保藏人类遗传资源、违法利用人类遗传资源参与国际合作以及违法对外提供人类遗传资源的违法所得以采集的人类遗传资源价值或者为人类遗传资源投入的资金数额作为违法所得。

Section 6: Enforcement

Article 118: [Destruction of Items]Where in addition to items that shall be destroyed in accordance with law, it is necessary to auction off the sealed or seized facilities and equipment to offset fines, it shall be handled in accordance with the law or relevant state regulations.

Destroyed items are to be addressed in accordance with relevant state provisions, and where there are no such provisions, then upon approval of the entity that made the administrative punishment decision, be it theMinistry of Science or Technology, a provincial, autonomous region, or directly-governed municipality department (commission, bureau) for science and technology, or the Xinjiang Construction and Production Corps' Bureau of Science and Technology, two or more law-enforcement personnel from that deciding entity are to oversee the destruction and draft a record. An inventory shall be made of destroyed items.

Article 119: [Filing] 省、自治区、直辖市科技厅(委、局)、新疆生产建设兵团科技局依法作出行政处罚的,应当自作出行政处罚决定之日起10日内报科技部备案。

Article 120: [Archiving]After the enforcement of administrative punishments is completed, case materials shall be archived in accordance with relevant provisions. 案卷立案归档后,任何单位和个人不得擅自增加、抽取、涂改和销毁案卷材料。

Chapter VII: Supplementary Provisions

Article 121: 【Timing Deliniations】Provisions in these Implementation Regulations refer to work days and do not include legally-prescribed rest days.

Article 122: 【Effective Date】These Implementing Rules will take effect on XX/XX/2022

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