Evolution and Prospects of Laboratory Animal Management: A Case Study of Shanghai's Development in the Past Decade

doi:10.12300/j.issn.1674-5817.2023.134

Abstract

Abstract:

There are differences in historical and cultural beliefs, development history, and levels of technological development among different countries and regions around the world. However, they have all established corresponding laboratory animal management systems that are suitable for their national conditions. In 2001, the Ministry of Science and Technology, together with six other ministries, jointly issued the administrative licensing system for experimental animals, which was an innovative measure in China's specialized management system for experimental animals.The State Administration for Market Regulation and the National Standards Committee, based on the welfare of experimental animals and the needs of scientific research, have formulated a series of national standards for laboratory animals, and the local experimental animal management institutions, experimental animal quality testing unit and professional training base have also been established, which provide a strong guarantee for the rapid and healthy development of experimental animal science. This paper reviews the development of experimental animal management in Shanghai in the past ten years, reflects the evolution of national experimental animal management in recent years, points out the weak links in the development process, and puts forward suggestions for the innovation and development of experimental animal work.

Key words: Laboratory animals, Historical evolution, Work development, Shanghai

CLC Number:

Q95-33

Yong ZHAO. Evolution and Prospects of Laboratory Animal Management: A Case Study of Shanghai's Development in the Past Decade[J]. Laboratory Animal and Comparative Medicine, 2023, 43(5): 492-503.

Figures/Tables 3

References 9

1	科技部财政部关于发布国家科技资源共享服务平台优化调整名单的通知:国科发基〔2019〕194号[A/OL].(2019-06-10)[2023-10-03].https://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/qtwj/qtwj2019/201906/t20190610_147031.html.
	Notice of the Ministry of Science and Technology and the Ministry of Finance on issuing the list of optimized and adjusted national science and technology resource sharing service platforms: GuoKeFaJi [2019] No. 194[A/OL].(2019-06-10)[2023-10-03]. https://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/qtwj/qtwj2019/201906/t20190610_147031.html.
2	上海市科学技术委员会. 关于印发«上海市实验动物许可证管理办法»的通知:沪科规〔2019〕13号[A/OL].(2019-12-31)[2023-10-03]. https://stcsm.sh.gov.cn/zwgk/kjzc/zcwj/kwzcxwj/20191231/0016-162980.html.
	Shanghai Municipal Commission of Science and Technology. Notice on the issuance of the "Shanghai Experimental Animal License Management Measures": HuKeGui [2019] No. 13[A/OL].(2019-12-31)[2023-10-03]. https://stcsm.sh.gov.cn/zwgk/kjzc/zcwj/kwzcxwj/20191231/0016-162980.html.
3	上海重点发展生物医药产业30年工业产值从50亿元增至近2000亿元[N/OL]. 中国新闻网, 2023-10-07. https://baijiahao.baidu.com/s?id=1779093732006966074&wfr=spider&for=pc.
	Shanghai focuses on developing the biopharmaceutical industry for 30 years: the industrial output value has increased from 5 billion yuan to nearly 200 billion yuan[N/OL]. China News Network, 2023-10-07. https://baijiahao.baidu.com/s?id=1779093732006966074&wfr=spider&for=pc.
4	贺争鸣, 李冠民, 荣瑞章, 等. 我国比较医学研究的开创、发展及在现代医学科学发展中的意义和作用[J]. 实验动物与比较医学, 2019, 39(2):90-93. DOI: 10.3969/j.issn.1674-5817.2019.02.004 .
	HE Z M, LI G M, RONG R Z, et al. Initiation and development of comparative medical research in China and its significance and role in the development of modern medical science[J]. Lab Anim Comp Med, 2019, 39(2):90-93. DOI: 10.3969/j.issn.1674-5817.2019.02.004 .
5	中国实验动物学会. 关于中国实验动物学会开展"实验动物机构福利伦理评价"活动的通知[EB/OL].(2023-02-20)[2023-10-03].http://www.calas.org.cn/article/view?cid=0_20_6493.
	Chinese Society of Experimental Animals. Notice on the implementation of the "Ethical Evaluation of Welfare in Experimental Animal Institutions" activity by the Chinese Society of Experimental Animals[EB/OL]. (2023-02-20) [2023-10-03]. http://www.calas.org.cn/article/view?cid=0_20_6493.
6	贺争鸣. 实验动物发展"十三五"规划的前期研究[R]. 沈阳: 中国北方第十三届实验动物科技年会, 2015.
	HE Z M. Preliminary research on the 13th Five Year Plan for the development of experimental animals[R]. Shenyang: 13th North China Experimental Animal Science and Technology Annual Conference, 2015.
7	上海市浦东新区促进张江生物医药产业创新高地建设规定[A/OL]. (2022-03-15)[2023-10-03]. http://www.spcsc.sh.cn/n8347/n8407/n9284/u1ai244473.html.
	Regulations on promoting the construction of Zhangjiang biomedical industry innovation highland in Pudong New Area of Shanghai [A/OL] (2022-03-15) [2023-10-03]. http://www.spcsc.sh.cn/n8347/n8407/n9284/u1ai244473.html.
8	BONAPARTE D, CINELLI P, DOUNI E, et al. FELASA guidelines for the refinement of methods for genotyping genetically-modified rodents: a report of the Federation of European Laboratory Animal Science Associations Working Group[J]. Lab Anim, 2013, 47(3):134-145. DOI: 10.1177/0023677212473918 .
9	WADMAN M. FDA no longer needs to require animal tests before human drug trials[J]. Science, 2023, 379(6628):127-128. DOI: 10.1126/science.adg6264 .

年度^* Year^*	检测单位数量 Number of testing units	不合格单位数量 Number of unqualified units	不合格项数量 Number of unqualified items	不合格项（实验动物级别、品种） Unqualified items (laboratory animal grade/varieties)
2010	11	4	4	小鼠肝炎病毒（清洁级小鼠）、支原体（清洁级SD大鼠）、兔出血症病毒免疫抗体合格率不达标（普通级新西兰兔）、体外寄生虫（普通级豚鼠）
2011	19	8	6	全部蠕虫（清洁级小鼠、大鼠）、仙台病毒（清洁级小鼠）、泰泽病原体（清洁级豚鼠）、绿脓杆菌（SPF级小鼠）、小鼠肝炎病毒（清洁级小鼠）、兔出血症病毒免疫抗体合格率不达标（普通级新西兰兔）
2014	28	6	4	全部蠕虫（SPF级小鼠、清洁级小鼠）、绿脓杆菌（SPF级小鼠）、体外寄生虫（普通级豚鼠）、肺炎克雷伯杆菌（SPF级小鼠）
2015	25	3	3	体外寄生虫（普通级新西兰兔）、全部蠕虫（清洁级SD大鼠）、仙台病毒（清洁级KM小鼠）
2016	25	5	4	狂犬病病毒免疫抗体合格率不达标（普通级犬）、布鲁杆菌（普通级犬）、体外寄生虫（普通级新西兰兔和豚鼠）、嗜肺巴斯德杆菌（SPF级大鼠）
2017	28	3	1	绿脓杆菌（SPF级裸小鼠、大鼠）
2018	27	2	2	嗜肺巴斯德杆菌（SPF级BALB/c和ICR小鼠）、体外寄生虫（普通级豚鼠、兔）
2019	28	3	3	布鲁杆菌（普通级犬）、泰泽病原体（清洁级豚鼠）和仙台病毒（SPF级SCID-BG小鼠、清洁级豚鼠）
2020	23	2	2	B病毒（普通级食蟹猴）、体外寄生虫（普通级新西兰兔）
2021	24	0	0	无
2022	24	3	2	肺炎克雷伯杆菌（SPF级NPSG小鼠和裸小鼠）、绿脓杆菌（BALB/c小鼠）

年度^* Year^*	检测单位数量 Number of testing units	不合格单位数量 Number of unqualified units	不合格项数量 Number of unqualified items	不合格项（实验动物级别、品种） Unqualified items (laboratory animal grade/varieties)
2010	11	4	4	小鼠肝炎病毒（清洁级小鼠）、支原体（清洁级SD大鼠）、兔出血症病毒免疫抗体合格率不达标（普通级新西兰兔）、体外寄生虫（普通级豚鼠）
2011	19	8	6	全部蠕虫（清洁级小鼠、大鼠）、仙台病毒（清洁级小鼠）、泰泽病原体（清洁级豚鼠）、绿脓杆菌（SPF级小鼠）、小鼠肝炎病毒（清洁级小鼠）、兔出血症病毒免疫抗体合格率不达标（普通级新西兰兔）
2014	28	6	4	全部蠕虫（SPF级小鼠、清洁级小鼠）、绿脓杆菌（SPF级小鼠）、体外寄生虫（普通级豚鼠）、肺炎克雷伯杆菌（SPF级小鼠）
2015	25	3	3	体外寄生虫（普通级新西兰兔）、全部蠕虫（清洁级SD大鼠）、仙台病毒（清洁级KM小鼠）
2016	25	5	4	狂犬病病毒免疫抗体合格率不达标（普通级犬）、布鲁杆菌（普通级犬）、体外寄生虫（普通级新西兰兔和豚鼠）、嗜肺巴斯德杆菌（SPF级大鼠）
2017	28	3	1	绿脓杆菌（SPF级裸小鼠、大鼠）
2018	27	2	2	嗜肺巴斯德杆菌（SPF级BALB/c和ICR小鼠）、体外寄生虫（普通级豚鼠、兔）
2019	28	3	3	布鲁杆菌（普通级犬）、泰泽病原体（清洁级豚鼠）和仙台病毒（SPF级SCID-BG小鼠、清洁级豚鼠）
2020	23	2	2	B病毒（普通级食蟹猴）、体外寄生虫（普通级新西兰兔）
2021	24	0	0	无
2022	24	3	2	肺炎克雷伯杆菌（SPF级NPSG小鼠和裸小鼠）、绿脓杆菌（BALB/c小鼠）

年度 Year	实验动物许可证/张 Number of laboratory animals license/piece	使用许可证/张 Use license/piece	生产许可证/张 Production license/piece
2013	163	132	31
2014	166	135	31
2015	173	141	32
2016	166	137	29
2017	161	132	29
2018	168	139	29
2019	174	144	30
2020	188	156	32
2021	192（合并16）	162（合并16）	30
2022	192（合并9）	163（合并9）	29
2023（至9月）	208（设施总量233个）	175（使用设施总量200个）	33

年度 Year	实验动物许可证/张 Number of laboratory animals license/piece	使用许可证/张 Use license/piece	生产许可证/张 Production license/piece
2013	163	132	31
2014	166	135	31
2015	173	141	32
2016	166	137	29
2017	161	132	29
2018	168	139	29
2019	174	144	30
2020	188	156	32
2021	192（合并16）	162（合并16）	30
2022	192（合并9）	163（合并9）	29
2023（至9月）	208（设施总量233个）	175（使用设施总量200个）	33

[1]	Lianxiang GUO. Revision of Standards for Microbiological and Parasitological Grades in Laboratory Animals and Its Comparison to Foreign Standards [J]. Laboratory Animal and Comparative Medicine, 2023, 43(4): 339-346.
[2]	Huan GOU, Xinying AN, Yujia TONG, Yan WANG, Shuang YANG. Analysis on the Development Status of Laboratory Animals in Japan [J]. Laboratory Animal and Comparative Medicine, 2023, 43(2): 194-204.
[3]	Chongyang QI, Lin CHEN, Man AI, Hang XU, Housen ZHANG. Safety Management Countermeasures Based on the Status of Laboratory Animal Administrative Licensing in Jiangsu Province [J]. Laboratory Animal and Comparative Medicine, 2023, 43(1): 79-85.
[4]	Xiaying LI, Yusheng WEI, Yonglu TIAN, Wanyong PANG. A Brief Interpretation of CCAC Guide on Humane Endpoints of Animals: 2022 Edition [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 566-571.
[5]	Jian WANG, Jin LU, Lingyun TAO, Hongkun FU, Cheng GAO, Baojin WU, Yao LI, Yufeng TAO. Analysis on the Standardized Expression of the Accredited Ability Scope for Hematology, Blood Biochemistry and Urinalysis in Laboratory Animal Clinical Testing [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 511-517.
[6]	Huiping LI, Chujun LIANG, Weibo ZHAO. The Current Status of Laboratory Animal License Administration in Guangdong Province [J]. Laboratory Animal and Comparative Medicine, 2022, 42(6): 577-582.
[7]	Xiuqing ZHENG, Zhiqiang SHAO, Jing SONG, Yuehua ZHANG, Jinhua SU. Practice of ABSL-2 Laboratory Process Management in Universities： Xiamen University as An Example [J]. Laboratory Animal and Comparative Medicine, 2022, 42(4): 364-370.
[8]	Wei ZHANG, Bin TANG, Yong ZHAO, Zhini ZHANG, Xinyan DENG. Tracking and Monitoring on Application of Micro-electrolyzed Sterile Water System in Laboratory Animal Barrier Facilities [J]. Laboratory Animal and Comparative Medicine, 2022, 42(2): 117-121.
[9]	Yuqin YANG. Biosafety Problems and Countermeasures in the Management of Barrier Facilities for Laboratory Animals [J]. Laboratory Animal and Comparative Medicine, 2022, 42(2): 95-101.
[10]	SONG Guoying, XU Yan, ZHU Meilin, ZHANG Hongwei, LI Pei. Practice and Exploration of Laboratory Animal and Laboratory Safety Training for Medical Freshmen [J]. Laboratory Animal and Comparative Medicine, 2021, 41(5): 450-454.
[11]	LIU Xiaonan, ZHANG Wei, MENG Xia, LU Jing. Design and Application of an Online Centralized Procurement System for Laboratory Animals in Universities: Capital Medical University as an Example [J]. Laboratory Animal and Comparative Medicine, 2021, 41(5): 459-465.
[12]	CHEN Lin, AI Man, XU Hang, QI Chongyang, SHI Aimin. Current Status of Administrative Licensing for Laboratory Animals in Jiangsu Province [J]. Laboratory Animal and Comparative Medicine, 2021, 41(4): 284-289.
[13]	JIANG Kun, TANG Yiwen, LIU Yanbin, CHEN Liming, TANG Hongbin. Design of Health Code Management Framework for Laboratory Animals [J]. Laboratory Animal and Comparative Medicine, 2021, 41(1): 66-69.
[14]	XU Qing-hua, TONG Lin. Application of Analytic Hierarchy Process in Biosafety Management of Laboratory Animals [J]. Laboratory Animal and Comparative Medicine, 2018, 38(4): 299-303.
[15]	SHENG Jun-jie, HU Qing-yuan, WANG Ke-zhou, LV Su-jun. An Introduction of 《Public Health Service Policy on Humane Care and Use of Laboratory Animals (Revised 2015)》 [J]. Laboratory Animal and Comparative Medicine, 2017, 37(4): 303-308.