On June 1, 2023, the Ministry of Science and Technology announced the Implementation Rules of the Regulations of the People's Republic of China on the Management of Human Genetic Resources (Decree No. 21 of the Ministry of Science and Technology, the "Implementation Rules"), which will be implemented on July 1, 2023, and at the same time the policy interpretation of the implementation Rules of the Regulations on the Management of Human Genetic Resources也新鲜出炉。In this paper, the key points of the relevant documents are sorted out to provide reference for the industry。
From the overall structure, the "Rules for Implementation" a total of 78 articles, divided into general provisions, general requirements, investigation and registration, administrative licensing and filing, supervision and inspection, administrative penalties and supplementary provisions of seven chapters。Combining the policy interpretation of the Implementing Rules, the Regulations of the People's Republic of China on the Management of Human Genetic Resources (hereinafter referred to as the "Regulations"), the Implementing Rules of the Regulations on the Management of Human Genetic Resources (hereinafter referred to as the "Regulations") and the finishing points of the Implementing Rules are compared as follows:
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) Clinical data not involved in population genetic studies (such as general laboratory test information such as blood routine, urine routine, liver and kidney function, blood biochemistry, growth and development indicators such as height and weight, questionnaire information, imaging/picture results, etc.)
(2) Clinical image data (such as B-ultrasound, CT, PET-CT, MRI, X-ray and other image data, interventional, fundus, endoscope, dermoscopy, pathological diagnosis and other image data)
(3) Protein data and metabolic data that do not contain human gene and genome data and are difficult to translate or transcribe into gene and genome data are not recognized as human genetic resource information, such as blood glucose, blood pressure, lipid and other data。
2. Key points of change: administrative license approval authority
Management regulations
The administrative departments of science and technology of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of human genetic resources in their respective administrative areas;Other relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall, within the scope of their respective functions and responsibilities, be responsible for the management of human genetic resources in their respective administrative areas。
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。
Article 4 [Local Administration system] Departments of Science and technology (committees and bureches) of provinces, autonomous regions and municipalities directly under the Central Government and Science and technology bureches of Xinjiang Production and Construction Corps shall be responsible for the administration of human genetic resources within their respective administrative areas。
(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，Organize and carry out the investigation of illegal cases in the region as entrusted by the Ministry of Science and Technology;(4) Accept the commission of the Ministry of Science and Technology to implement human genetic resources related matters。
Implementation rules
The Ministry of Science and Technology shall entrust it according to lawRelated organizationTo carry out formal review and technical review of administrative license application materials for human genetic resources, as well as human genetic resources filing, prior reporting, supervision and inspection, administrative punishment and other work。
Article 4 The Departments of Science and Technology (committees and bureaus) of provinces, autonomous regions and municipalities directly under the Central Government and the Science and Technology Bureau of Xinjiang Production and Construction Corps (hereinafter referred to as provincial science and technology administrative departments) shall be responsible for the administration of the following human genetic resources in their respective regions:
(1) Supervision, inspection and daily management of human genetic resources;(2) investigation and handling of illegal cases concerning human genetic resources within the scope of its functions and powers;(3) To carry out a survey of human genetic resources in the region, as entrusted by the Ministry of Science and Technology;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
Foreign organizations, individuals and institutions established or actually controlled by them may not collect or preserve human genetic resources in China, and may not provide human genetic resources abroad
（Strict standards in practice, no matter that any market entity that accepts foreign investment, no matter how much foreign entities hold shares, no matter whether foreign entities directly hold shares, will be identified as foreign entities)
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：
(1) foreign organizations or individuals holding or indirectly holding more than 50 percent of the shares, equity, voting rights, property shares or other similar rights and interests of the organization;
(2) The shares, equity rights, voting rights, property shares or other similar rights and interests held or indirectly held by overseas organizations or individuals do not reach 50%，However, the voting rights or other rights and interests of the decision-making body are sufficient to have a significant influence on the decisions of the decision-making body or the internal management of the decision-making body;
(3) Overseas organizations and individuals, through agreements or other arrangements, are sufficient to exert significant influence on the decision-making, operation and management of the organization;
(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:
(1) foreign organizations or individuals holding or indirectly holding more than 50 percent of the shares, equity, voting rights, property shares or other similar rights and interests of the organization;
(2) Foreign organizations or individuals holding or indirectly holding less than 50% of the shares, equity, voting rights, property shares or other similar rights and interests of the institution, but the voting rights or other rights and interests enjoyed by them are sufficient to dominate or exert significant influence on the decision-making, management and other acts of the institution;
(3) Foreign organizations and individuals, through investment relationships, agreements or other arrangements, are sufficient to dominate or exert significant influence on the decision-making, management and other acts of the organization;
(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
For emergencies such as public health incidents, the Ministry of Science and Technology has established a rapid approval mechanism, and the application for administrative permission of human genetic resources involved in emergency response should be expedited。
For the application for administrative license of human genetic resources subject to rapid approval, the Ministry of Science and Technology shall, in accordance with the principles of unified command, efficient and rapid examination and approval, expedite the organization of the acceptance, review and examination of administrative license applications。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 GuideImportant genetic family refers to a consigneous group suffering from genetic diseases or having hereditary special physical or physical characteristics, and the affected family or having hereditary special physical or physical characteristics have more than five members, involving three generations。
Implementation rules
Genetically-important families are groups of consigneous persons suffering from hereditary diseases and possessing hereditary special physical or physical characteristics, and members of such groups suffering from hereditary diseases and possessing hereditary special physical or physical characteristics are related to three or more generations;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 GuideHuman genetic resources in specific areas refer to human genetic resources that live in isolation or special environment for a long time and have special physical characteristics or have adaptive traits in physiological characteristics。Specific areas are not classified on the basis of whether they are inhabited by ethnic minorities。
Implementation rules
The human genetic resources in a specific area refer to the human genetic resources that live in isolation or special environment for a long time and have special physical characteristics or adaptive traits in physiological characteristics。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) The categories prescribed by the department of science and Technology under The State Council refer to rare diseases and people with special physical or physiological characteristics with significant differences。
(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。
Human genetic resource collection activities involved in clinical trials to obtain the marketing authorization of relevant drugs and medical devices in China are not included in this category, and there is no need to apply for administrative permission for human genetic resource collection。
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 ChinaPreservation refers to the act of preserving human genetic resources of legitimate origin under appropriate environmental conditions to ensure their quality and safety for future scientific research.It does not include temporary storage behavior after laboratory testing in accordance with laws, regulations or clinical research protocols。
Implementation rules
Preservation of human genetic resources refers to the act of preserving human genetic resources of legal origin under appropriate environmental conditions to ensure their quality and safety for future scientific research.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"
Add "Where the preservation of human genetic resources for which an administrative license should be applied also involves the collection of human genetic resources, the applicant only needs to apply for an administrative license for the preservation of human genetic resources,There is no need to apply for a separate administrative license for human genetic resources collection。”
3. Changes: International cooperation permit changes
Management regulations
Article 23 In the course of conducting international cooperative scientific research using human genetic resources in China, where the partner, research purpose, research content, cooperation term and other major matters are changed,The examination and approval procedures for the change shall be completed。
Draft for comment
Article 62 In the process of using human genetic resources in China to carry out international cooperative scientific research,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;
(2) The name of the participating entity other than the cooperative entity listed in paragraph 1 of Article 61 above, and the legal entity of the parties to the cooperation has been changed;
(3) Changes in the research program, but does not involve changes in the type, quantity or use of human genetic resources, or the content after the change does not exceed the approved scope。
Implementation rules
Article 47 After obtaining the administrative license for international cooperation in scientific research on human genetic resources,Under the following circumstances, the licensee does not need to apply for change, but shall submit a written explanation of the change of the matter and corresponding materials to the Ministry of Science and Technology:
(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;
(4) The research content or research program has been changed, but it does not involve changes in the type, quantity or use of human genetic resources, or the content after the change does 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
In order to obtain the marketing authorization of related drugs and medical devices in China, the use of human genetic resources in clinical institutions to carry out international cooperative clinical trials, which do not involve the exit of human genetic resources materials, does not need to be approved。
Draft for comment
To obtain the relevant drugs and medical devices in China marketing approval，Cooperating with Chinese units to carry out international cooperative clinical trials using Chinese human genetic resources in clinical institutions, which do not involve the exit of human genetic resources materials，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) The sample testing unit involved in the national partnership filing can be designated by the clinical trial program, and is no longer limited to the clinical institution (expanded from "clinical institution" to "clinical medical and health institution").。A contract can be signed directly between the sponsor (or contract research organization, i.e. CRO) and a third-party testing unit。
(2) "The unit entrusted by the clinical institution to conduct testing, analysis and processing of remaining samples" is changed to "the domestic unit designated by the clinical trial plan".。
5. Changes: Backup information
Management regulations
Article 24 To carry out international cooperative scientific research using China's human genetic resources, the Chinese unit and its researchers shall be guaranteed to participate in the whole process and substantively during the cooperation, and all records and data information in the research process shall be fully open to the Chinese unit and provided with backup。
Draft for comment
Article 30 [Data Backup] Where human genetic resource information is provided or open for use by overseas organizations, individuals and institutions established or actually controlled by them, information backup shall be submitted to the information backup institutions designated by the Ministry of Science and Technology and filed with the Ministry of Science and Technology。
Article 47 The provision or open use of human genetic resources information to foreign organizations, individuals and institutions established or actually controlled by them shall be submitted to the Ministry of Science and Technology for the record, and the record materials shall contain the following contents。
Implementation rules
Article 36 Where the information of human genetic resources is provided or opened for use by overseas organizations, individuals and institutions established or actually controlled by them, the Chinese owner of the information shall applyAdvance 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
(d) to provide or open the use of foreign organizations, individuals and their establishment or actual control of institutions for the protection of human genetic resources of the potential risk assessment。
In the course of the implementation of an international scientific research cooperation that has obtained administrative permission or a clinical trial that has completed the filing of an international cooperation, the Chinese unit provides the information of human genetic resources generated by the cooperation to the foreign unit,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，Shall not endanger the public health, national security and social and public interests of our country;May affect China's public health, national security and social public interest，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
Article 37 The provision or open use of human genetic resources information to overseas organizations, individuals and institutions established or actually controlled by them, which may affect the public health, national security and social and public interests of China, shall pass the security review organized by the Ministry of Science and Technology。
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;(3) exome sequencing and genome sequencing information resources with more than 500 cases;(4) other circumstances that may affect China's public health, national security and social and public interests。
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
The purpose and content of the research are changed, the type, quantity and use of human genetic resources involved in the research program are changed, or the sponsor, the group leader, the contract research organization, the third-party laboratory and other major matters are changed。
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，It only involves the change of the total amount not exceeding 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;(4) The research content or research plan is changed，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
Changes in the type, quantity and use of human genetic resources, or changes in major matters such as partners, research programs, research contents and research purposes。
The recordholder shall handle the recordkeeping changes in a timely manner。
Non-material change
If the change of research program or research content does not involve a change in the type, quantity or use of human genetic resources, it is not necessary to file the change, butA 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。
Note: Refer to "Jin MAO comments on | the Management art of wide and mighty - Chapter by Chapter interpretation of the Implementing Rules of the Regulations on the Management of Human Genetic Resources (below)", if there is infringement, please contact to delete。
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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，Suspension of the Office for the Management of Human Genetic Resources;Abolish the "China Human Genetic Resources Management Office" (administrative approval seal), "China Human Genetic Resources Management Office approval seal" (export certificate seal);The "Special Seal of the Ministry of Science and Technology for Administrative License Acceptance of Human Genetic Resources", the "Special Seal of the Ministry of Science and Technology for Administrative License of Human Genetic Resources" and the "Special Seal of the Ministry of Science and Technology for the record of Human Genetic Resources" were activated.。
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。
Third, effective from 9:00 on 1 July 2023, the Human Genetic Resources Management Information System (http://apply.hgrg.net) online trial run。The original platform (URL: http://grants.most.gov.The deadline for accepting cn/grants is 17:00 on June 30, 2023, and the advance report on the exit of human genetic resources materials, the provision of information to the outside world or the open use of human genetic resources will be temporarily accepted by the original network platform, and the specific deadline will be notified separately。
※ Special Notice: The above views are from the main points of related articles, only represent personal opinions, if involved in infringement issues, please contact to delete。
Reference material
1. Announcement on Matters related to Adjusting the Management of Human Genetic Resources - Ministry of Science and Technology of the People's Republic of China (most).gov.cn)
2, the Ministry of Science and Technology Decree No. 21 Implementation Rules of the Regulations on the Management of Human Genetic Resources - The Ministry of Science and Technology of the People's Republic of China (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. Jin MAO comments on the management art of | : Chapter by Chapter interpretation of the Implementing Rules of the Regulations on the Management of Human Genetic Resources (Part 2) Wang Yaping Fan Sujuan
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
