中国实验动物法规和管理体系-高诚

实验动物相关的国家部门标准 农业部、卫生部 MOH; MOA Ministerial standards regarding lab animals 实验动物相关的地方标准 地方质监局 Provincial AQSIQ Provincial standards regarding lab animals 实验动物产品标准 公司 Companies Standards for lab animal products
MOST, Ministry of Science and Technology; PDST: provincial department of science and technology; CALAS: Chinese Association for Laboratory Animal Sciences 虚线部分表示CALAS是独立于MOST的机构，它没有管理地方协会和学会的权力，但是它通过监督、教育、培训等对这些协会学会进 行监督.The dotted arrows indicate that CALAS is independent from MOST; it has no power to administer the provincial associations and institutions but plays a role in the self-regulation of lab animal science (e.g., through supervision, continuing education and training, etc.


实验动物质量控制体系 Lab Animal Quality Control Network
“九五”计划期间，实验动物发展计划应运而生，该计划的建立促进了实验动物质量控制体系的形 成，而后者进一步促进了由科技部和地方科技厅监督的实验动物质量监测中心的形成 The Laboratory Animal Development Program for the Ninth Five-Year Plan established a national lab animal quality control network, which determines requirements for lab animal quality monitoring centers overseen by MOST and the PDSTs 为监管地方实验动物质量监测中心，科技部颁布了相应的纲领和具体标准 MOST subsequently issued the Guideline and Detailed Criteria for the Review of Provincial Laboratory Animal Monitoring Centers 实验动物质量监测中心的目的在于探索研究实验技术、培训技术员、视察机构、对地方实验动物 管理体系进行年审以及对具有争议的监测结果进行仲裁 The task of these centers is to explore research on testing techniques, train technicians, carry out site inspections and annual review of provincial lab animal monitoring centers, and arbitrate disputed monitoring results 实验动物质量控制体系包含涉及微生物、寄生虫、遗传、病理、饲料、环境和设施的六个国家中 心以及26个地方省市中心 The quality monitoring network comprises six national centers covering microbiology, parasitology, genetics, pathology, feedstuff, environment, and facilities, as well as 26 provincial centers in 23 provinces
Current Laboratory Animal Laws Regulations, Policies & in China 中国实验动物法规和管理体系 Gao Cheng 高诚
Office of Shanghai Administrative Committee for Laboratory Animals 上海市实验动物管理委员会办公室 2010-09-18
中国实验动物管理机构 Framework of the Chinese Lab Animal Administration System
视察Site Visit
管理 Administration
监督 Supervision
监测 Monitoring
管理 Administration
教育 Education
国家规章 National regulation
国家文件 国家部门 National document Ministry 地方规章 Provincial regulation 地方文件 Provincial document 地方部门 Province 地方部门 Province 国家标准 National 技术标准 Standard 国家部门标准 Ministerial 地方标准 Provincial 产品标准 Product
实验动物标准体系及质量管理 Lab Animal Standards and Quality Control
1994年，国家技术监督局颁布了一系列国家标准，与实验动物相关的有47项 In 1994 the China State Bureau of Technical Supervision issued a series of national standards, 47 of which apply to lab animals 2001年，国家对这些国家标准进行了修订，并将与实验动物相关的标准扩增到了83项 The 2001 revision of these standards increased the number to 83 2005年，中国实验动物标准化管理国家技术委员会成立，并颁布了97项实验动物质量控制的 国家标准。标准内容涉及微生物、遗传、饲料、环境和设施、SPF鸡等领域 In 2005 National Technical Committee on Laboratory Animal Science of the Standardization Administration of China was established and set 93 standards for lab animal quality control covering five areas: microbiology, genetics, feedstuff and SPF chickens 除此之外，医学和农业部也建立了相应的实验动物质量相关的标准。在某些发达省市（北京、 上海、广东和江苏）以及一些大型生物医药公司则执行自行设定的更高的标准 In addition, other entities, such as the ministries of medicine and agriculture, have set lab animal quality standards. And some of the more developed provinces and cities (e.g., Beijing, Shanghai, Guangdong, and Jiangsu) impose their own standards, as do some larger companies or enterprises for their products
中国实验动物科学的发展 Laboratory Animal Science in China
1918年 齐长庆首次开始繁殖小鼠用于实验。在此之后 ，中国从印度、日 本、欧洲和美国引入了很多动物品系 The first known appearance of laboratory animals in China was in 1918, when Dr. Changqing Qi bred mice for experiments 1949 年 很多近交系小鼠在国内繁殖成功：C-1、TA-1、615、TA-2等 Chinese scientists cultivated many inbred mouse strains such as C-1, TA-1, 615 and TA-2 in 1949 1982年 第一届国际实验动物会议举行
The first national LAS conference took place in 1982 1983年 国家卫生部颁布了第一个实验动物管理条例
The Ministry of Public Health (MPH) issued the first LA regulations in 1983
实验动物相关政策法规 Relevant Regulations & Policies for Laboratory Animal in China
类别 Type 行政法规 Administrative statute 法律 Law 国务院批准 Approved by State Council 地方法律 Provincial law 多部门联合发布 Joint ministries 单个部门发布 Single ministry 文件名称 Name 发布机构 Administration 实验动物管理条例 科技部 MOST guideline on Administration of Lab Animals 地方实验动物管理办法（北京、湖北、云南） 地方人民代表大会 Provincial Provincial Regulation on Administration of People's Congress Lab Animals (Beijing, Hubei, Yunnan) 实验动物质量管理办法 科技部等七部委 Seven ministries Regulation on the Management of Lab Animal Quality Control 实验动物管理法规 科技部、卫生部、食品药品监督检验 局、农业部 Regulation on the Managementof Lab Animals MOST, MOH, SFDA, MOA 国务院各部门发布的文件 国家各有关部门 Ministries Document issued by Ministries of State Council 地方法规、指导性政策 Provincial regualtions, guidelines 地方政府发布的文件 Document issued by provincial governments 实验动物相关的国家标准 National standards regarding lab animals 地方政府 Provincial governments 地方政府 Provincial governments 国家质检总局 AQSIQ
中国实验动物科学的发展 Laboratory Animal Science in China
1988年 国家科技部建立了最初的中国实验动物管理部 门。随后，各省市和自治区也开始成立相应的管理部门， 颁布相应的法律法规。 In 1988, the Ministry of Science and Technology (MOST) established its primary administrative responsibility for LAS in China with the Regulation on the Administration of Laboratory Animals used in research, education and testing. Most provinces, municipalities, and autonomous regions began to issue similar regulations to strengthen oversight.