中国医药生物技术2025,Vol.20Issue(1) :19-23.DOI:10.3969/j.issn.1673-713X.2025.01.004

构建生物安全防线:中国生物制品监管的进展与挑战

Research on building a biosecurity defense line:advances and challenges in China's biological product regulation

梅妮 周坛树 张华 吴浩
中国医药生物技术2025,Vol.20Issue(1) :19-23.DOI:10.3969/j.issn.1673-713X.2025.01.004

构建生物安全防线:中国生物制品监管的进展与挑战

Research on building a biosecurity defense line:advances and challenges in China's biological product regulation

梅妮 1周坛树 2张华 3吴浩2
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作者信息

  • 1. 201210 上海药品审评核查中心;201203 上海市生物医药科技发展中心
  • 2. 201210 上海药品审评核查中心
  • 3. 201203 上海市生物医药科技发展中心
  • 折叠

摘要

在生物制品研究和生产加速发展的背景下,中国生物安全立法和监管框架正不断完善,特别是在《中华人民共和国生物安全法》实施后,生物安全管理得到加强.本文深入探讨了中国在生物制品监管领域生物安全防线的构建,分析了生物安全管理的要求、面临的主要问题以及预防控制策略;通过法规分析、文献研究等方法,进一步梳理了生物制品生物安全管理的风险因素,并提出了管理对策;明确相关单位在生物制品开发中的主体责任、加强生物制品研究与生产的关键环节管理、建立监管机构间的联合监管机制对提升生物安全管理至关重要;最后提出了完善法律法规、加强教育培训、提高监管能力等策略,旨在提高中国生物制品的生物安全管理水平,确保生物制品的质量和安全,进一步保障公共健康和安全.

Abstract

The article highlights the continuous improvement of China's legislative and regulatory framework for biosecurity amidst the rapid development of biological products,particularly following the enforcement of the"Biosafety Law of the People's Republic of China,"which has bolstered biosafety management.It explores the establishment of a biosecurity defense line in the regulation of biological products in China,examining the requirements for biosafety management,challenges faced,and strategies for preventive control.Utilizing regulatory analysis and literature research,the article identifies risk factors in biosafety management of biological products and suggests corresponding management strategies.It emphasizes the importance of defining the primary responsibilities of relevant entities in biological product development,strengthening management of crucial research and production stages,and establishing collaborative regulatory mechanisms between oversight agencies to enhance biosafety management.The article concludes with recommendations to enhance legislation and regulations,improve education and training,and bolster regulatory capacities to advance biosafety management in China's biological products,ensuring product quality and safety,as well as safeguarding public health.

关键词

生物制品/生物技术/安全管理

Key words

biological products/biotechnology/biosafety management

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出版年

2025
中国医药生物技术
中国医药生物技术协会

中国医药生物技术

影响因子:0.368
ISSN:1673-713X
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