June 1, 2023，The Ministry of Science and Technology promulgated the Implementation Rules of the Regulations of the People's Republic of China on the Management of Human Genetic Resources (Ministry of Science and Technology Order No. 21)，"Rules for Implementation")，It will be implemented on July 1, 2023，At the same time, the policy interpretation of the implementation Rules of the Regulations on the Management of Human Genetic Resources is also fresh。In this paper, the key points of the relevant documents are sorted out to provide reference for the industry。
从整体结构看，Rules for Implementation共计78条，分为总则，总体要求，调查与登记，行政许可与备案，监督检查，行政处罚和附则七个章节。结合Rules for Implementation政策解读、《亚洲彩票十大平台》（下文简称《十大靠谱彩票平台》)、《亚洲彩票十大平台》（Draft for comment）（下文简称《亚洲彩票十大平台》）和Rules for Implementation整理要点比较如下：
01-Organize the main points of each chapter
Chapter One: General rules
1. Key points of change: refine the core concept of "human genetic resources"
Management regulations
The term "human genetic resources" in these Regulations includes human genetic resources materials and human genetic resources information。
Human genetic resources materials refer to organs, tissues, cells and other genetic materials containing human genomes, genes and other genetic materials。
Human genetic resources information refers to the data and other information generated by the use of human genetic resources materials。
Draft for comment
Human genetic resources include human genetic resources materials and human genetic resources information。
Human genetic resources materials refer to organs, tissues, cells and other genetic materials containing human genomes, genes and other genetic materials。
Human genetic resources information refers to human genes, genome data and other information materials generated by the use of human genetic resources materials。
Implementation rules
The term "human genetic resource information" as used in Article 2 of the Regulations includes information generated from the use of human genetic resource materialsThe number of human genes and genomesData and other information。
The human genetic resource information mentioned in the preceding paragraph does not include clinical data, imaging data, protein data and metabolic data。
According to the Frequently Asked Questions on Human Genetic Resources Management (Q&A 2)
（1）不涉及人群基因研究的临床数据（如血常规、尿常规、肝肾功、血生化等一般实验室检查信息，身高、体重等生长发育指标，问卷信息，影像学/图片结果数据等）
（2）临床图像数据（如B超、CT、PET-CT、核磁共振、X射线等影像数据，介入、眼底镜、内窥镜、皮肤镜、病理诊断等图片数据）
（3）不含The number of human genes and genomes据，且较难据此翻译或转录为基因、基因组数据的蛋白质数据、代谢数据不被认定为Human genetic resources信息，例如血糖、血压、血脂等数据。
2. Key points of change: administrative license approval authority
Management regulations
省、自治区、直辖市人民政府科学技术行政部门负责本行政区域Human genetic resources管理工作；省、自治区、直辖市人民政府其他有关部门在各自的职责范围内，负责本行政区域有关Human genetic resources管理工作。
Draft for comment
Relevant institutions may be entrusted by the Ministry of Science and Technology to undertake specific support work in terms of license acceptance, professional support, supervision and management。
第四条【十大靠谱彩票平台】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Human genetic resources管理工作。
(1) Daily management and supervision of human genetic resources;(2) Accept the commission of the Ministry of Science and Technology，To organize surveys of human genetic resources in the region;(3) To be responsible for the investigation and punishment of illegal cases within the scope of its functions and powers，根据科技部委托组织开展本区域的违法案件调查等工作；（四）接受科技部委托实施Human genetic resources相关事项。
Implementation rules
The Ministry of Science and Technology shall entrust it according to lawRelated organization，开展Administrative licensing of human genetic resources申请材料的形式审查、技术评审，以及Human genetic resources备案、事先报告、监督检查、行政处罚等工作。
第四条 省、自治区、直辖市科学技术厅（委、局）、新疆生产建设兵团科学技术局（以下称省级科技行政部门）负责本区域下列Human genetic resources管理工作：
（一）Human genetic resources监督检查与日常管理；（二）职权范围内的Human genetic resources违法案件调查处理；（三）根据科技部委托，开展本区域Human genetic resources调查、Administrative licensing of human genetic resourcesInvestigation and handling of illegal cases of human genetic resources。
The new functions of the science and technology administrative departments at the provincial level - according to the delegation of the Ministry of Science and Technology, to carry out the administrative licensing work of human genetic resources in the region。
Chapter Two: General requirements
1. Change point: "foreign unit" situation
Management regulations
外国组织、个人及其设立或者The actual control of the agencyIt is not allowed to collect and preserve human genetic resources in China, and it is not allowed to provide human genetic resources abroad
（实践操作中从严标准，无论认为凡是接受境外投资的市场主体，无论境外主体持股比例多少，无论境外主体是否直接持股，都将被认定为外方单位）
Draft for comment
Overseas organizations, individuals and institutions established or actually controlled by them(hereinafter referred to as "foreign unit")It is not allowed to collect and preserve human genetic resources in China, and it is not allowed to provide human genetic resources abroad。
[Foreign unit] refers to overseas organizations and overseas organizations and individuals established orThe actual control of the agency。
The actual control mentioned above includes the following situations：
（一）境外组织、个人持有或者间接持有机构百分之五十以上的股份、股权、表决权、财产份额或者其他类似权益；
（二）境外组织、个人持有或者间接持有机构的股份、股权、表决权、财产份额或者其他类似权益虽然未达到百分之五十，但其所享有的决策机构表决权或其他权益足以对该机构的决议或对该机构的决策、内部管理产生重大影响；
（三）境外组织、个人通过协议或者其他安排，足以对机构的决策、经营管理等重大事项施加重大影响；
(4) Other circumstances identified by the Ministry of Science and Technology。
Implementation rules
Foreign organizations and institutions established or actually controlled by foreign organizations or individuals(hereinafter referred to as the foreign unit)And overseas individuals may not collect and preserve Chinese human genetic resources within the territory of China, and may not provide Chinese human genetic resources outside the territory。
The term "institutions established or actually controlled by overseas organizations or individuals" as mentioned in Article 11 of these Rules shall include the following circumstances:
（一）境外组织、个人持有或者间接持有机构百分之五十以上的股份、股权、表决权、财产份额或者其他类似权益；
（二）境外组织、个人持有或者间接持有机构的股份、股权、表决权、财产份额或者其他类似权益不足百分之五十，但其所享有的表决权或者其他权益足以对机构的决策、管理等行为进行支配或者施加重大影响；
（三）境外组织、个人通过投资关系、协议或者其他安排，足以对机构的决策、管理等行为进行支配或者施加重大影响；
(4) Other circumstances provided for by laws, administrative regulations and rules。
Compared to the Regulations，The draft for Comments proposes the concept of "actual holding"，If the entity directly established by the unit exists overseas organizations or individuals，Regardless of the shareholding (share) of the foreign organization or individual，The entity may be identified as an entity "established" by a foreign organization or individual，And is therefore identified as a "foreign unit";
Compared with the Draft for Comments, the Implementation Rules further specify the concept of "foreign units"，Stipulating that the establishment or actual control of overseas organizations and individuals shall adopt the judgment standard of "actual control";An entity is a foreign entity only if it is physically controlled by a foreign organization or individual。
Article 11 of the Rules specifies that domestic real control institutions located in Hong Kong and Macao are regarded as Chinese units。
2. Key changes: Fast-track approval mechanism
Management regulations
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Draft for comment
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Implementation rules
针对公共卫生事件等突发事件，科技部建立快速审批机制，对突发事件应急处置中涉及的Administrative licensing of human genetic resources申请，应当加快办理。
对实施快速审批的Administrative licensing of human genetic resources申请，科技部按照统一指挥、高效快速、科学审批的原则，加快组织开展行政许可申请的受理、评审、审查等工作。The circumstances, procedures, time limits, requirements and other matters of rapid approval shall be separately stipulated by the Ministry of Science and Technology。
In response to emergencies such as major public health incidents, the Ministry of Science and Technology has established a rapid approval mechanism。
Chapter four: administrative licensing and filing
1. Key points of change: Scope of collection permit
Management regulations
Important genetic families
Draft for comment
Collection Permit Guide：Important genetic families是指患有遗传性疾病或具有遗传性特殊体质或生理特征的有血缘关系的群体，患病家系或具有遗传性特殊体质或生理特征成员五人以上，涉及三代。
Implementation rules
Important genetic families是指患有遗传性疾病、具有遗传性特殊体质或者生理特征的有血缘关系的群体，且该群体中患有遗传性疾病、具有遗传性特殊体质或者生理特征的成员涉及三代或者三代以上，High blood pressure, diabetes, red-green color blindness, hemophilia and other common diseases are not included。
Management regulations
Human genetic resources in specific areas
Draft for comment
Collection Permit Guide：Human genetic resources in specific areas是指在隔离或者特殊环境下长期生活，并具有特殊体质特征或者在生理特征方面有适应性性状发生的Human genetic resources。Specific areas are not classified on the basis of whether they are inhabited by ethnic minorities。
Implementation rules
Human genetic resources in specific areas是指在隔离或者特殊环境下长期生活，并具有特殊体质特征或者在生理特征方面有适应性性状发生的Human genetic resources。Specific areas are not classified on the basis of whether they are inhabited by ethnic minorities。
Management regulations
The administrative department of science and technology under The State Council shall specify the types and quantities of human genetic resources
Draft for comment
Collection Permit Guide：
（1）国务院科学技术部门规定的种类是指罕见病、具有显著性差异的特殊体质或生理特征的人群。
(2) Accumulate more than 500 people
Implementation rules
Collection of human genetic resources for large-scale population studies involving more than 3,000 individuals。Large-scale population studies include, but are not limited to, cohort studies, cross-sectional studies, clinical studies, and constitutional studies。
为取得相关药品和医疗器械在我国上市许可的临床试验涉及的Human genetic resources采集活动不在此列，无需申请Human genetic resourcesCollection administrative license。
Remove regulatory requirements for collection of people with rare diseases, special physical or physiological characteristics with significant differences
2. Changes: Scope of deposit license
Management regulations
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Draft for comment
Guidelines on Administrative Licensing Matters for the Preservation of Human Genetic Resources in China：保藏是指将来源合法的Human genetic resources保存在适宜环境条件下，保证其质量和安全，用于未来科学研究的行为，It does not include temporary storage behavior after laboratory testing in accordance with laws, regulations or clinical research protocols。
Implementation rules
Human genetic resources保藏活动是指将有合法来源的Human genetic resources保存在适宜环境条件下，保证其质量和安全，用于未来科学研究的行为，It does not include temporary storage for teaching purposes, in accordance with the requirements of laws and regulations or clinical research protocols after laboratory testing。
New "for teaching Purposes"
新增“应当申请行政许可的Human genetic resources保藏活动同时涉及Human genetic resources采集的，申请人仅需要申请Human genetic resourcesAdministrative license for preservation，There is no need to apply for a separate administrative license for human genetic resources collection。”
3. Changes: International cooperation permit changes
Management regulations
第二十三条 在利用我国Human genetic resources开展国际合作科学研究过程中，合作方、研究目的、研究内容、合作期限等重大事项发生变更的，The examination and approval procedures for the change shall be completed。
Draft for comment
第六十二条【亚洲彩票十大平台】在利用我国Human genetic resources开展国际合作科学研究过程中，The following circumstances do not need to apply for permission to change, but the relevant materials should be submitted to the Ministry of Science and Technology to explain and report：
(a) the research plan remains unchanged, only involving the cumulative number of cases does not exceed 10% of the approved number of changes;
（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Human genetic resources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。
Implementation rules
Article 47 After obtaining the administrative license for international cooperation in scientific research on human genetic resources,In any of the following circumstances,The licensee does not need to apply for change, but shall submit to the Ministry of Science and Technology a written explanation of the change of the matter and the corresponding materials:
(1) The research content or research program is unchanged, and only the total amount involved in the cumulative change does not exceed 10% of the approved amount;
(2) The participating units other than those listed in Article 46 of these Rules are changed;
(3) The name of the legal entity of the partner is changed;
（四）研究内容或者研究方案发生变更，However, it does not involve changes in the type, quantity or use of human genetic resources, or the contents after the changes do not exceed the approved scope。
Details of the changes are as follows: Requirements for various licensing and filing changes in the Implementation Rules
4. Major changes: Changes in the filing of international cooperative clinical trials
Management regulations
To obtain the relevant drugs and medical devices in China marketing approval，在临床机构利用我国Human genetic resources开展国际合作临床试验、不涉及Human genetic resources材料出境的，No approval required。
Draft for comment
To obtain the relevant drugs and medical devices in China marketing approval，与中方单位合作在临床机构利用我国Human genetic resources开展国际合作临床试验、不涉及Human genetic resources材料出境的，In accordance with the following circumstances, the parties to the cooperation, the type, quantity and use of human genetic resources to be used shall be filed with the Ministry of Science and Technology，No approval required。
Implementation rules
In order to obtain the marketing authorization of relevant drugs and medical devices in China, inClinical health institutionsApproval is not required for the use of Chinese human genetic resources to carry out international cooperative clinical trials that do not involve the exit of human genetic resources materials。
(1)涉及国合备案的样本检测单位可由临床试验方案指定，不再仅限于临床机构委托（由“临床机构”扩大为“Clinical health institutions”。A contract can be signed directly between the sponsor (or contract research organization, i.e. CRO) and a third-party testing unit。
(2) “由临床机构委托的单位进行检测、分析和剩余样本处理”变更为“临床试验方案指定的境内单位”。
5. Changes: Backup information
Management regulations
第二十四条 利用我国Human genetic resources开展国际合作科学研究，应当保证中方单位及其研究人员在合作期间全过程、实质性地参与研究，研究过程中的所有记录以及数据信息等完全向中方单位开放并向中方单位提供备份。
Draft for comment
第三十条【十大靠谱彩票平台】将Human genetic resources信息向Overseas organizations, individuals and institutions established or actually controlled by them提供或者开放使用的，应当向科技部指定的信息备份机构提交信息备份并向科技部备案。
第四十七条【十大靠谱彩票平台】Make human genetic resource information available or open for use to foreign organizations, individuals and institutions established or effectively controlled by them，应向科技部提交备案，备案材料应当包含以下内容。
Implementation rules
第三十六条 将Human genetic resources信息向Overseas organizations, individuals and institutions established or actually controlled by them提供或者开放使用的，中方信息所有者Advance reports and information backups should be submitted to the Ministry of Science and Technology。The following information shall be submitted in the prior report to the Ministry of Science and Technology
（四）向Overseas organizations, individuals and institutions established or actually controlled by them提供或者开放使用对我国Human genetic resources保护的潜在风险评估情况。
已取得行政许可的国际科学研究合作或者已完成备案的国际合作临床试验实施过程中，中方单位向外方单位提供合作产生的Human genetic resources信息的，If the international cooperation agreement has been agreed to be used by both parties, there is no need to separately report and submit information backup in advance。
Information backup from "backup", "record" to "pre-report" and "backup", the procedure is more strict。
6. Changing points: Security review situation
Management regulations
Make human genetic resource information available or open for use to foreign organizations, individuals and institutions established or effectively controlled by them，不得危害我国公众健康、国家安全和社会公共利益；可能影响我国公众健康、国家安全和社会公共利益的，It shall pass the safety review organized by the administrative department of science and technology under The State Council。
Draft for comment
Article 49 [Scope of Security review] The circumstances of security review include the provision or open use of the following information:
(1) Information on human genetic resources of important genetic families;
(b) Information on human genetic resources in specific areas;
(3) exome sequencing and genome sequencing information resources of people with more than 500 people;
(4) Other information that may affect China's public health, national security and social and public interests。
Implementation rules
第三十七条 将Human genetic resources信息向Overseas organizations, individuals and institutions established or actually controlled by them提供或者开放使用，可能影响我国公众健康、国家安全和社会公共利益的，应当通过科技部组织的安全审查。
Situations in which a security review should be conducted include：
(1) Information on human genetic resources of important genetic families;
(b) Information on human genetic resources in specific areas;（三）人数大于500例的外显子组测序、基因组测序信息资源；（四）可能影响我国公众健康、国家安全和社会公共利益的其他情形。
Identify situations that require a Ministry of Science and Technology security review。
02-Rules for ImplementationVarious licensing and filing change requirements
1. Human genetic resourcesCollection administrative license
Material change
The entity participating in the collection activity, the collection purpose, the collection plan or the collection content are changed。
The licensee shall submit an application for alteration to the Ministry of Science and Technology。
Non-material change
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2. Human genetic resourcesAdministrative license for preservation
Material change
Changes in major matters such as storage purpose, storage scheme or storage content。
The licensee shall submit an application for alteration to the Ministry of Science and Technology。
Non-material change
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3. Human genetic resourcesAdministrative license for international scientific research cooperation
Material change
研究目的、研究内容发生变更，研究方案涉及的Human genetic resources种类、数量、用途发生变更，或者申办方、组长单位、合同研究组织、第三方实验室等其他重大事项发生变更的。
The licensee shall submit an application for alteration to the Ministry of Science and Technology。
Non-material change
In any of the following circumstances,The licensee does not need to apply for change, but shall submit to the Ministry of Science and Technology a written explanation of the change of the matter and the corresponding materials:
(1) The research content or research plan remains unchanged，仅涉及总量累计不超过获批数量10%变更的；（2）本Implementation rules第四十六条所列合作单位以外的参与单位发生变更的；（3）合作方法人单位名称发生变更的；（4）研究内容或者研究方案发生变更，However, it does not involve changes in the type, quantity or use of human genetic resources, or the contents after the changes do not exceed the approved scope。
4. International cooperative clinical trials were completed
Material change
Human genetic resources种类、数量、用途发生变更，或者合作方、研究方案、研究内容、研究目的等重大事项发生变更的。
The recordholder shall handle the recordkeeping changes in a timely manner。
Non-material change
研究方案或者研究内容变更不涉及Human genetic resources种类、数量、用途变化的，不需要办理备案变更，但A written explanation of the change and relevant materials shall be submitted to the Ministry of Science and Technology before the change activities begin。
5. Provide or open access to human genetic resources information to overseas organizations, individuals and institutions established or actually controlled by them
Material change
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Non-material change
The use, recipient and other matters have changed。
A change report shall be submitted to the Ministry of Science and Technology before the implementation of the change。
注：参考“金茂评论 | 宽猛相济的管理艺术——《亚洲彩票十大平台》逐章解读（下）"，如有侵权，请联系删除。
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June 21, 2023, Ministry of Science and Technology on the adjustment of the management of human genetic resources
One is from July 1, 2023，中止“Human genetic resources管理办公室”运行；废除“中国Human genetic resources管理办公室”（行政审批用章）、“中国Human genetic resources管理办公室审批专用章”（出口出境证明用章）；启用“科技部Administrative licensing of human genetic resources受理专用章”、“科技部Administrative licensing of human genetic resources专用章”和“科技部Human genetic resources备案专用章”。
Second, the Ministry of Science and Technology entrusted the China Biotechnology Development Center to carry out technical work related to the management of human genetic resources。
三是自2023年7月1日9:00起，Human genetic resources管理信息系统（网址http://apply.hgrg.net) online trial run。The original platform (URL: http://grants.most.gov.cn/grants)受理截止时间为2023年6月30日17:00，Human genetic resources材料出境、信息对外提供或开放使用事先报告暂由原网络平台受理，具体截止时间另行通知。
※ 特别声明：以上观点来自相关文章的要点整理，仅代表个人意见，如涉及侵权问题请联系删除。
Reference material
1、关于调整Human genetic resources管理工作相关事宜的公告 -中华人民共和国科学技术部 (most.gov.cn)
2、科学技术部令第21号 Human genetic resourcesManagement regulationsImplementation rules-中华人民共和国科学技术部 (most.gov.cn)
3. Regulations of the People's Republic of China on the Management of Human Genetic Resources _ Science and Technology _ Chinese Government website (www.gov.cn)
4. Implementation Rules of the Regulations on the Management of Human Genetic Resources (Draft for comment)
5. Ten highlights of the Implementation Rules of the Regulations on the Management of human genetic Resources Quick overview Ge Yongbin Dong Jianping, etc
6、金茂评论 | 宽猛相济的管理艺术——《亚洲彩票十大平台》逐章解读（下）王亚萍 凡素娟
7. Hao Tian's interpretation | Key points of the Implementation Rules of the Regulations on the Management of Human Genetic Resources Zhou Han, Jiang Wenjie and Guo Fan
