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Order of the State Council of the People's Republic of China
(No. 424)
The Regulation on the Bio-safety Management of Pathogenic Microbe Labs was adopted at the 69th executive meeting of the State Council on November 5, 2004. It is hereby promulgated and shall be implemented as of the promulgation date.
Premier Wen Jiabao
November 12, 2004
Regulation on the Bio-safety Management of Pathogenic Microbe Labs
| | 中华人民共和国国务院令
（第424号）
《病原微生物实验室生物安全管理条例》已经2004年11月5日国务院第69次常务会议通过，现予公布，自公布之日起施行。
总理 温家宝
二00四年十一月十二日
病原微生物实验室生物安全管理条例
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Chapter I General Provisions
| | 第一章 总则
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Article 1 The present Regulation is formulated for the purpose of further strengthening the bio-safety management of pathogenic microbe labs (hereinafter referred to as the labs) and protecting the health of the laboratory technical personnel and the general public.
| | 第一条 为了加强病原微生物实验室（以下称实验室）生物安全管理，保护实验室工作人员和公众的健康，制定本条例。
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Article 2 The present Regulation shall apply to the bio-safety management of labs within the territory of the People's Republic of China as well as the experimental activities which are conducted in the labs.
The term "pathogenic microbe" as mentioned in the present Regulation refers to any microorganism capable of causing human or animal diseases.
The term "experimental activities" as mentioned in the present Regulation refers to the activities which are conducted in the labs, such as research, teaching, testing and diagnosis relating to the strains or samples of pathogenic bacterium (viruses).
| | 第二条 对中华人民共和国境内的实验室及其从事实验活动的生物安全管理，适用本条例。
本条例所称病原微生物，是指能够使人或者动物致病的微生物。
本条例所称实验活动，是指实验室从事与病原微生物菌（毒）种、样本有关的研究、教学、检测、诊断等活动。
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Article 3 The administrative department of health of the State Council shall be responsible for the supervision over the bio-safety of the labs relating to human health and the experimental activities which are conducted in the labs.
The administrative department of veterinary of the State Council shall be responsible for supervision over the bio-safety of labs relating to animals and the experimental activities conducted in the labs.
The other relevant departments of the State Council shall, under their respective functions, be responsible for the bio-safety management of the labs and the experimental activities which are conducted in the labs.
The people's governments at the county level or above and their pertinent departments shall, under their respective functions, be responsible for the bio-safety management of the labs and the experimental activities which are conducted in the labs.
| | 第三条 国务院卫生主管部门主管与人体健康有关的实验室及其实验活动的生物安全监督工作。
国务院兽医主管部门主管与动物有关的实验室及其实验活动的生物安全监督工作。
国务院其他有关部门在各自职责范围内负责实验室及其实验活动的生物安全管理工作。
县级以上地方人民政府及其有关部门在各自职责范围内负责实验室及其实验活动的生物安全管理工作。
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Article 4 The state adopts categorized management over the pathogenic microbes, and graded management over the labs.
| | 第四条 国家对病原微生物实行分类管理，对实验室实行分级管理。
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Article 5 The state adopts the uniform lab bio-safety standards. A lab shall conform to the national standards and specifications.
| | 第五条 国家实行统一的实验室生物安全标准。实验室应当符合国家标准和要求。
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Article 6 The entity, which launched a lab, and its administrative department shall be responsible for the management of the routine activities of the lab and shall conduct the duties of establishing a sound safety management system, checking and maintaining the experimental apparatus and equipment as well as controlling the laboratory infection.
| | 第六条 实验室的设立单位及其主管部门负责实验室日常活动的管理，承担建立健全安全管理制度，检查、维护实验设施、设备，控制实验室感染的职责。
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Chapter II Classification and Management of Pathogenic Microbes
| | 第二章 病原微生物的分类和管理
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Article 7 The state classifies the pathogenic microbes into four categories according to the infectivity and the degree of harm to the infected individual or to the mass:
The pathogenic microbes in Category I refer to the microbes capable of causing very severe human or animal diseases, and the microbes undiscovered or declared as eliminated in our country.
The pathogenic microbes in Category II refer to the microbes capable of causing serious human or animal diseases, which can be easily transmitted from person to person, animal to person or animal to animal, directly or indirectly.
The pathogenic microbes in Category III refer to the microbes capable of causing human or animal diseases, but they usually cannot severely endanger the human, animals or environment, have limited risk of spreading and seldom cause severe diseases after laboratory infection, moreover, we have got effective treatment and prevention measures against them.
The pathogenic microbes in Category IV refer to the microbes that are usually incapable of causing human or animal disease.
The pathogenic microbes in Categories I and II are generally called highly pathogenic microbes.
| | 第七条 国家根据病原微生物的传染性、感染后对个体或者群体的危害程度，将病原微生物分为四类：
第一类病原微生物，是指能够引起人类或者动物非常严重疾病的微生物，以及我国尚未发现或者已经宣布消灭的微生物。
第二类病原微生物，是指能够引起人类或者动物严重疾病，比较容易直接或者间接在人与人、动物与人、动物与动物间传播的微生物。
第三类病原微生物，是指能够引起人类或者动物疾病，但一般情况下对人、动物或者环境不构成严重危害，传播风险有限，实验室感染后很少引起严重疾病，并且具备有效治疗和预防措施的微生物。
第四类病原微生物，是指在通常情况下不会引起人类或者动物疾病的微生物。
第一类、第二类病原微生物统称为高致病性病原微生物。
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Article 8 The directory of pathogenic microbes capable of spreading from person to person shall be formulated, modified and issued by the administrative department of health of the State Council in consultation with other relevant departments of the State Council. The directory of pathogenic microbes capable of spreading from animal to animal shall be formulated, modified and issued by the administrative department of veterinary of the State Council in consultation with other relevant departments of the State Council.
| | 第八条 人间传染的病原微生物名录由国务院卫生主管部门商国务院有关部门后制定、调整并予以公布；动物间传染的病原微生物名录由国务院兽医主管部门商国务院有关部门后制定、调整并予以公布。
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Article 9 A lab shall meet the following conditions when gathering samples of pathogenic microbes:
| | 第九条 采集病原微生物样本应当具备下列条件：
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(1) Having equipment up to the bio-safety protection level for gathering pathogenic microbes;
| | （一）具有与采集病原微生物样本所需要的生物安全防护水平相适应的设备；
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(2) Having personnel with the relevant professional knowledge and operating skills;
| | （二）具有掌握相关专业知识和操作技能的工作人员；
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(3) Having effective measures to prevent the spreading and infection of pathogenic microbes; and
| | （三）具有有效的防止病原微生物扩散和感染的措施；
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(4) Having technical methods and approaches to ensure the quality of samples of pathogenic microbes.
During the course of gathering samples of highly pathogenic microbes, the personnel shall prevent the spreading and infection of pathogenic microbes, and shall make detailed records of the source thereof as well as the gathering course and approach.
| | （四）具有保证病原微生物样本质量的技术方法和手段。
采集高致病性病原微生物样本的工作人员在采集过程中应当防止病原微生物扩散和感染，并对样本的来源、采集过程和方法等作详细记录。
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Article 10 The strains or samples of highly pathogenic bacteria (virus) shall be transported by way of land transportation. If there is no land road, they may be transported through waterway. In emergency or when it is necessary to transport them abroad, they may be transported through civil aviation.
| | 第十条 运输高致病性病原微生物菌（毒）种或者样本，应当通过陆路运输；没有陆路通道，必须经水路运输的，可以通过水路运输；紧急情况下或者需要将高致病性病原微生物菌（毒）种或者样本运往国外的，可以通过民用航空运输。
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Article 11 For the transport of strains or samples of highly pathogenic bacteria (virus), the following conditions shall be met:
| | 第十一条 运输高致病性病原微生物菌（毒）种或者样本，应当具备下列条件：
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(1) The purpose of transport, use of highly pathogenic bacteria (virus) and acceptance entity shall meet the provisions of the administrative department of health or the administrative department of veterinary of the State Council;
| | （一）运输目的、高致病性病原微生物的用途和接收单位符合国务院卫生主管部门或者兽医主管部门的规定；
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(2) The container of strains or samples of highly pathogenic bacteria (virus) shall be sealed up, moreover, the container or packing materials shall satisfy the requirements for prevention of water, breakage and leakage as well as endurance of high (low) temperature and high pressure; and
| | （二）高致病性病原微生物菌（毒）种或者样本的容器应当密封，容器或者包装材料还应当符合防水、防破损、防外泄、耐高（低）温、耐高压的要求；
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(3) The container or packing materials shall be printed with the bio-risk signs, warnings and hints as provided by the administrative department of health or the administrative department of veterinary of the State Council.
The transport of strains of samples of highly pathogenic bacteria (virus) shall be subject to the approval of the administrative department of health or the administrative department of veterinary of the people's government at or above the province level. If such transport is within the administrative area of a province, autonomous region, or municipality directly under the Central Government, it shall be subject to the administrative department of health or the administrative department of veterinary of the people's government of this province, autonomous region, or municipality directly under the Central Government. If such transport goes beyond a province, autonomous region, or municipality directly under the Central Government, or heads abroad, it shall be subject to the preliminary examination of the administrative department of health or the administrative department of veterinary of the people's government of the province, autonomous region, or municipality directly under the Central Government where the place of departure is located, then respectively subject to the approval of the administrative department of health or the administrative department of veterinary of the State Council.
If the entry-exit inspection and quarantine institution needs, during the process of inspection and quarantine, to transport any samples of pathogenic microbe, it shall be subject to the approval of the entry-exit inspection and quarantine department of the State Council and shall be simultaneously reported to the administrative department of health or the administrative department of veterinary of the State Council.
The transport of strains or samples of highly pathogenic bacteria (virus) through civil aviation shall, in addition to obtaining the approval in accordance with Paragraphs 2 and 3, obtain the approval of the administrative department of civil aviation of the State Council.
The relevant administrative departments shall examine the application materials relating to the transport of strains and samples of highly pathogenic bacteria (virus) submitted by an applicant, it shall promptly grant the applicant an approval if the aforesaid application materials meet the conditions as listed in the first Paragraph of this Article.
| | （三）容器或者包装材料上应当印有国务院卫生主管部门或者兽医主管部门规定的生物危险标识、警告用语和提示用语。
运输高致病性病原微生物菌（毒）种或者样本，应当经省级以上人民政府卫生主管部门或者兽医主管部门批准。在省、自治区、直辖市行政区域内运输的，由省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门批准；需要跨省、自治区、直辖市运输或者运往国外的，由出发地的省、自治区、直辖市人民政府卫生主管部门或者兽医主管部门进行初审后，分别报国务院卫生主管部门或者兽医主管部门批准。
出入境检验检疫机构在检验检疫过程中需要运输病原微生物样本的，由国务院出入境检验检疫部门批准，并同时向国务院卫生主管部门或者兽医主管部门通报。
通过民用航空运输高致病性病原微生物菌（毒）种或者样本的，除依照本条第二款、第三款规定取得批准外，还应当经国务院民用航空主管部门批准。
有关主管部门应当对申请人提交的关于运输高致性病原微生物菌（毒）种或者样本的申请材料进行审查，对符合本条第一款规定条件的，应当即时批准。
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Article 12 As to the transport of strains or samples of highly pathogenic bacteria (virus), 2 or more persons shall be specially assigned for escorting it, and the corresponding safety protection measures shall be taken.
No entity or individual may transport any strains or samples of pathogenic bacteria (virus) by trolley (bus) or city railway.
| | 第十二条 运输高致病性病原微生物菌（毒）种或者样本，应当由不少于2人的专人护送，并采取相应的防护措施。
有关单位或者个人不得通过公共电（汽）车和城市铁路运输病原微生物菌（毒）种或者样本。
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Article 13 Where it is necessary to transport strains or samples of highly pathogenic bacteria (virus) through a public transport tool of railway, road or civil aviation, the carrier shall transport them upon the approval documents as required in Article 11 of the present Regulation.
The carrier and the escorts shall jointly take measures to ensure the safety of the strains or samples of highly pathogenic bacteria (virus) and prevent them from being stolen, robbed, lost and leaked.
| | 第十三条 需要通过铁路、公路、民用航空等公共交通工具运输高致病性病原微生物菌（毒）种或者样本的，承运单位应当凭本条例第十一条规定的批准文件予以运输。
承运单位应当与护送人共同采取措施，确保所运输的高致病性病原微生物菌（毒）种或者样本的安全，严防发生被盗、被抢、丢失、泄漏事件。
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Article 14 The bacteria (virus) strain preservation centers or special labs designated by the administrative department of health or the administrative department of veterinary of the State Council (hereinafter referred to the preservation institutions) shall conduct the task of preserving the pathogenic bacteria (virus) strains and samples in a centralized manner.
A preservation institution shall, in compliance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, preserve the pathogenic bacteria (virus) strains and samples delivered by the labs, and shall provide the labs with the pathogenic bacteria (virus) strains and samples.
A preservation institution shall formulate strict safety and preservation system, make good records of the ins, outs and preservation of pathogenic bacteria (virus) strains and samples, establish an archives system and assign special responsible persons. It shall prepare special storerooms or tanks to preserve the highly pathogenic bacteria (virus) strains and samples in a separate way.
No preservation institution may charge any fee for the preservation or supply of pathogenic bacteria (virus) strains and samples, the expenses shall be guaranteed by the public finance of the same level from the budget of entity.
The administrative measures for the preservation institutions shall be formulated by the administrative department of health jointly with the administrative department of veterinary of the State Council.
| | 第十四条 国务院卫生主管部门或者兽医主管部门指定的菌（毒）种保藏中心或者专业实验室（以下称保藏机构），承担集中储存病原微生物菌（毒）种和样本的任务。
保藏机构应当依照国务院卫生主管部门或者兽医主管部门的规定，储存实验室送交的病原微生物菌（毒）种和样本，并向实验室提供病原微生物菌（毒）种和样本。
保藏机构应当制定严格的安全保管制度，作好病原微生物菌（毒）种和样本进出和储存的记录，建立档案制度，并指定专人负责。对高致病性病原微生物菌（毒）种和样本应当设专库或者专柜单独储存。
保藏机构储存、提供病原微生物菌（毒）种和样本，不得收取任何费用，其经费由同级财政在单位预算中予以保障。
保藏机构的管理办法由国务院卫生主管部门会同国务院兽医主管部门制定。
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Article 15 A preservation institution shall, upon the strength of the approval documents obtained by a lab for conducting the experimental activities relating to the highly pathogenic microbes in accordance with the present Regulation, provide the lab with the highly pathogenic bacteria (virus) strains and samples, and shall make records on this.
| | 第十五条 保藏机构应当凭实验室依照本条例的规定取得的从事高致病性病原微生物相关实验活动的批准文件，向实验室提供高致病性病原微生物菌（毒）种和样本，并予以登记。
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Article 16 After a lab completes its relevant experimental activities, it shall, in accordance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, timely destroy the pathogenic bacteria (virus) strains and samples on the spot or deliver them to the preservation institution for preservation.
Where a preservation institution accepts the pathogenic bacteria (virus) strains and samples delivered by a lab, it shall make records and shall issue a certification of acceptance.
| | 第十六条 实验室在相关实验活动结束后，应当依照国务院卫生主管部门或者兽医主管部门的规定，及时将病原微生物菌（毒）种和样本就地销毁或者送交保藏机构保管。
保藏机构接受实验室送交的病原微生物菌（毒）种和样本，应当予以登记，并开具接收证明。
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Article 17 Where any highly pathogenic bacteria (virus) strains or samples are stolen, robbed, lost or leaked during the course of transportation or storage, the carrying entity, escorts or preservation institution shall take necessary control measures, shall report to the administrative department in charge of the carrying entity, the entity for which the escorts are working and the administrative department in charge of the preservation institution within 2 hours and shall simultaneously report to the administrative department of health or the administrative department of veterinary of the local people's government at the county level, as well as report to the public security organ if any such strains or samples are stolen, robbed or lost. After receiving such a report, the administrative department of health or the administrative department of veterinary shall report to the people's government at the same level within 2 hours and shall simultaneously report to the superior administrative department of health or the administrative department of veterinary, as well as the administrative department of health or the administrative department of veterinary of the State Council.
After receiving such a report, the people's government at the county level shall report to the people's government of the city divided into district or the superior people's government. The people's government of the city divided into district shall, within 2 hours after receiving such a report, report to the people's government of the province, autonomous region, or municipality directly under the Central Government. The people's government of the province, autonomous region, or municipality directly under the Central Government shall report to administrative department of health or the administrative department of veterinary of the State Council within 1 hour after receiving such a report.
Any entity or individual who discovers the container or packing materials of highly pathogenic bacteria (virus) shall timely report to the nearby administrative department of health or the administrative department of veterinary, which shall organize an investigation and shall take necessary control measures in good time.
| | 第十七条 高致病性病原微生物菌（毒）种或者样本在运输、储存中被盗、被抢、丢失、泄漏的，承运单位、护送人、保藏机构应当采取必要的控制措施，并在2小时内分别向承运单位的主管部门、护送人所在单位和保藏机构的主管部门报告，同时向所在地的县级人民政府卫生主管部门或者兽医主管部门报告，发生被盗、被抢、丢失的，还应当向公安机关报告；接到报告的卫生主管部门或者兽医主管部门应当在2小时内向本级人民政府报告，并同时向上级人民政府卫生主管部门或者兽医主管部门和国务院卫生主管部门或者兽医主管部门报告。
县级人民政府应当在接到报告后2小时内向设区的市级人民政府或者上一级人民政府报告；设区的市级人民政府应当在接到报告后2小时内向省、自治区、直辖市人民政府报告。省、自治区、直辖市人民政府应当在接到报告后1小时内，向国务院卫生主管部门或者兽医主管部门报告。
任何单位和个人发现高致病性病原微生物菌（毒）种或者样本的容器或者包装材料，应当及时向附近的卫生主管部门或者兽医主管部门报告；接到报告的卫生主管部门或者兽医主管部门应当及时组织调查核实，并依法采取必要的控制措施。 |
Chapter III Establishment and Management of Labs
| | 第三章 实验室的设立与管理
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Article 18 The state shall classify the labs into Level 1, Level 2, Level 3 and Level 4 in light of their pathogenic microbe bio-safety protection levels as well as in accordance with the national standards for the bio-safety of labs.
| | 第十八条 国家根据实验室对病原微生物的生物安全防护水平，并依照实验室生物安全国家标准的规定，将实验室分为一级、二级、三级、四级。
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Article 19 The newly building, rebuilding or expanding a Level 3 or 4 lab or importing a Level 3 or 4 movable lab, the following provisions shall be complied with:
| | 第十九条 新建、改建、扩建三级、四级实验室或者生产、进口移动式三级、四级实验室应当遵守下列规定：
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(1) It shall be in compliance with the national planning on the bio-safety labs and shall go through the relevant examination and approval formalities;
| | （一）符合国家生物安全实验室体系规划并依法履行有关审批手续；
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(2) It has been examined and approved by the science and technology administrative department of the State Council;
| | （二）经国务院科技主管部门审查同意；
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(3) It meets the technical standards for building a national bio-safety lab;
| | （三）符合国家生物安全实验室建筑技术规范；
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(4) It has undergone the environmental impact evaluation pursuant to the Environmental Impact Evaluation Law of the People's Republic of China as well as has been examined and approved by the environmental protection administrative department; and
| | （四）依照《中华人民共和国环境影响评价法》的规定进行环境影响评价并经环境保护主管部门审查批准；
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(5) The bio-safety protection level is in keeping with the experimental activities which it will conduct.
The "national planning on the bio-safety labs" as mentioned in the preceding paragraph shall be formulated by the investment administrative department of the State Council jointly with other relevant departments of the State Council. When formulating such planning, the principle of controlling the aggregate number, distributing reasonably and sharing the resources shall be observed, and hearings or argumentations shall be held for soliciting the opinions of the experts in public health, environmental protection, investment management and lab management.
| | （五）生物安全防护级别与其拟从事的实验活动相适应。
前款规定所称国家生物安全实验室体系规划，由国务院投资主管部门会同国务院有关部门制定。制定国家生物安全实验室体系规划应当遵循总量控制、合理布局、资源共享的原则，并应当召开听证会或者论证会，听取公共卫生、环境保护、投资管理和实验室管理等方面专家的意见。
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Article 20 The labs of Level 3 and 4 shall be subject to the national accreditation for laboratories.
The accreditation agencies determined by the certification accreditation supervisory department of the State Council shall, in pursuance of the national standards for laboratory bio-safety and the relevant provisions of the present Regulation, complete the accreditation process for the Levels 3 and 4 labs and shall issue a corresponding bio-safety lab certificate to each bio-safety lab that has passed the accreditation. Such a certificate has a five-year valid period.
| | 第二十条 三级、四级实验室应当通过实验室国家认可。
国务院认证认可监督管理部门确定的认可机构应当依照实验室生物安全国家标准以及本条例的有关规定，对三级、四级实验室进行认可；实验室通过认可的，颁发相应级别的生物安全实验室证书。证书有效期为5年。
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Article 21 No Level 1 or 2 lab may conduct experimental activities relating to highly pathogenic microbes. A Level 3 or 4 lab may conduct such activities, but it shall satisfy the following requirements:
| | 第二十一条 一级、二级实验室不得从事高致病性病原微生物实验活动。三级、四级实验室从事高致病性病原微生物实验活动，应当具备下列条件：
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(1) The experimental purpose and the planned experimental activities shall meet the requirements of the administrative department of health or the administrative department of veterinary of the State Council;
| | （一）实验目的和拟从事的实验活动符合国务院卫生主管部门或者兽医主管部门的规定；
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(2) It has passed the national accreditation for laboratories;
| | （二）通过实验室国家认可；
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(3) It has personnel who can meet the needs of the planned experimental activities; and
| | （三）具有与拟从事的实验活动相适应的工作人员；
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(4) Its quality of construction project is up to the standards upon check of the construction administrative department.
The administrative department of health or the administrative department of veterinary of the State Council shall, in light of its own functions, check whether the Levels 3 and 4 labs meet the above-mentioned requirements and shall issue to the qualified labs the qualification certificates for conducting experimental activities relating to highly pathogenic microbes.
| | （四）工程质量经建筑主管部门依法检测验收合格。
国务院卫生主管部门或者兽医主管部门依照各自职责对三级、四级实验室是否符合上述条件进行审查；对符合条件的，发给从事高致病性病原微生物实验活动的资格证书。
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Article 22 Where a lab, which has obtained a qualification certificate for conducting experimental activities relating to highly pathogenic microbes, needs to conduct experimental activities relating to any highly pathogenic microbes or suspected highly pathogenic microbes, it shall, in accordance with the provisions of the administrative department of health or the administrative department of veterinary of the State Council, report to the administrative department of health or the administrative department of veterinary of the people's government at or above the province level for approval. It shall report the results and particulars of such experimental activities to the original approval department.
When a lab applies for or accept a scientific research project relating to any highly pathogenic microbes, it shall meet the needs of scientific research and the bio-safety requirements, shall be up to the corresponding bio-safety protection level and shall be subject to the approval of the administrative department of health or the administrative department of veterinary of the State Council.
| | 第二十二条 取得从事高致病性病原微生物实验活动资格证书的实验室，需要从事某种高致病性病原微生物或者疑似高致病性病原微生物实验活动的，应当依照国务院卫生主管部门或者兽医主管部门的规定报省级以上人民政府卫生主管部门或者兽医主管部门批准。实验活动结果以及工作情况应当向原批准部门报告。
实验室申报或者接受与高致病性病原微生物有关的科研项目，应当符合科研需要和生物安全要求，具有相应的生物安全防护水平，并经国务院卫生主管部门或者兽医主管部门同意。
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Article 23 When an entry-exit inspection and quarantine institution, medical health institution or animal disease prevention institution carries out inspection or diagnosis work, if it discovers any highly pathogenic microbes or suspected highly pathogenic microbes and needs to further conduct experimental activities relating to such highly pathogenic microbes, it shall obtain an approval as required by the present Regulation and shall conduct the pertinent experimental activities in a lab with the corresponding qualification certificate.
．．．．．． | | 第二十三条 出入境检验检疫机构、医疗卫生机构、动物防疫机构在实验室开展检测、诊断工作时，发现高致病性病原微生物或者疑似高致病性病原微生物，需要进一步从事这类高致病性病原微生物相关实验活动的，应当依照本条例的规定经批准同意，并在取得相应资格证书的实验室中进行。
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