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The “precautionary principle” has been a cornerstone in the regulation of biotechnology; however, its applicability to synthetic biology (SynBio) is increasingly questioned. With its vast array of applications and transformative potential across sectors such as healthcare, agriculture, and conservation, SynBio presents unique regulatory challenges. This chapter examines the current international regulatory landscape for SynBio, focusing on key regions including the United States, the European Union, and India. It emphasizes the fragmented nature of governmental oversight and explores the critical challenges that future policy decisions must address to effectively manage the risks and benefits associated with SynBio advancements.

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Synthetic Biology Regulatory Landscape

  • 工具书词条

  • 发表日期：

    2026年

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  • Abhinav Warrier,
  • Rashi Diwan,
  • Gayatri D. Lele,
  • Srushti N. Tijare,
  • Tanvi R. Sonawane,
  • Shamlan M. S. Reshamwala

摘要

The “precautionary principle” has been a cornerstone in the regulation of biotechnology; however, its applicability to synthetic biology (SynBio) is increasingly questioned. With its vast array of applications and transformative potential across sectors such as healthcare, agriculture, and conservation, SynBio presents unique regulatory challenges. This chapter examines the current international regulatory landscape for SynBio, focusing on key regions including the United States, the European Union, and India. It emphasizes the fragmented nature of governmental oversight and explores the critical challenges that future policy decisions must address to effectively manage the risks and benefits associated with SynBio advancements.