实验动物与比较医学 ›› 2024, Vol. 44 ›› Issue (4): 455-462.DOI: 10.12300/j.issn.1674-5817.2024.030

• 实验动物管理 • 上一篇    下一篇

《广东省实验动物管理条例》制度特点及近十年实施情况分析

邓少嫦, 林丹荣, 梁楚军, 雷伟侨, 杨锦淳, 赵维波()()   

  1. 广东省实验动物监测所, 广州 510663
  • 收稿日期:2024-02-27 修回日期:2024-05-06 出版日期:2024-09-06 发布日期:2024-08-25
  • 通讯作者: 赵维波(1976—),男,硕士,研究员,研究方向:实验动物科技管理研究。E-mail: zhaoweibo@gdlami.com。ORCID: 0009-0009-5400-0448
  • 作者简介:邓少嫦(1979—),女,硕士,副研究员,研究方向:实验动物与比较医学、实验动物科技管理研究。E-mail:dengshaochang@gdlami.com
  • 基金资助:
    广东省科技计划项目“《广东省实验动物条例》配套文件和执行评估研究”(2017B070705007);“自发性强直性脊柱炎食蟹猴模型的研究及应用平台”(2021B1212060002)

Analysis of Institutional Characteristics and Implementation of Guangdong Province Laboratory Animals Ordinance in the Past Decade

DENG Shaochang, LIN Danrong, LIANG Chujun, LEI Weiqiao, YANG Jinchun, ZHAO Weibo()()   

  1. Guangdong Laboratory Animals Monitoring Institute, Guangzhou 510663, China
  • Received:2024-02-27 Revised:2024-05-06 Published:2024-08-25 Online:2024-09-06
  • Contact: ZHAO Weibo (ORCID: 0009-0009-5400-0448), E-mail: zhaoweibo@gdlami.com

摘要:

《广东省实验动物管理条例》(以下简称《条例》)于2010年10月正式颁布实施,明确授权广东省实验动物监测机构开展实验动物质量监测工作并承担相应法律责任,明确了实验动物生产和使用规范,推动了实验动物福利伦理关注,标志着广东省实验动物管理工作进入了法制化管理的新阶段。通过制定《条例》配套文件,广东省积极推行行政执法工作规范化、标准化以及“放管服”措施,在促进广东省实验动物规范管理和支撑生物医药创新发展方面发挥了积极的作用,在实验动物科技平台建设、标准化工作、特色资源保存研制和人才队伍建设等方面取得了显著成绩。然而,随着科技进步、社会经济发展和立法工作的深入,《条例》在实施过程中也发现了一些需要完善的内容,如实验动物福利内容规定需进一步明确、基因工程动物管理需加强具体指引、从业人员安全福利保障相关规定需完善、“一票否决制”需进一步细化落实、实验动物标准化建设仍需进一步推动、实验资源共享需探索有效机制。本文对《条例》的制度特点、立法后的实施情况和成效,以及实施中存在的问题及对策等方面进行梳理归纳,总结了广东省近10年的实验动物管理实践经验,以期为实验动物立法提供参考。

关键词: 广东省, 实验动物, 管理条例, 法制化建设, 实施情况

Abstract:

The Guangdong Province Laboratory Animals Ordinance (the GPLAO), officially enacted and implemented in October 2010, marked a new phase of legal management in the administration of laboratory animals in Guangdong Province. The GPLAO clearly authorizes the laboratory animal monitoring institutes in Guangdong Province to conduct laboratory animal quality monitoring and assume corresponding legal responsibilities. It also specifies the standards for the production and use of laboratory animals, while bringing attention to laboratory animal welfare and ethics. Through the formulation of supporting documents, the active promotion of the standardization and regulation of administrative law enforcement, and the implementation of measures to delegate power, streamline administration, and optimize government services, significant improvements have been made in the standardized management of laboratory animals in Guangdong Province and in supporting the innovative development of biomedicine. Moreover, notable achievements have been made in areas such as the construction of experimental animal technology platforms, standardization work, the preservation and development of unique resources, and talent pool development. However, with the advancements in science and technology, social economy, and legislative work, some aspects in the GPLAO have been identified for improvement. These include the need for clearer provisions on laboratory animal welfare, more specific guidelines for the management of genetically engineered animals, improved regulations on the safety and welfare of practitioners, further refined implementation of the "one-vote veto system", continued promotion of laboratory animal standardization, and the exploration of effective mechanisms for resource sharing. This paper reviews and summarizes the institutional characteristics, post-legislation implementation, and effectiveness of the GPLAO, as well as the issues and countermeasures identified during the implementation. It concludes the laboratory animals management practices in Guangdong Province during the past 10 years, aiming to provide a reference for laboratory animal legislation.

Key words: Guangdong Province, Laboratory animals, Legal construction, Implementation

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