Koch Muffy, Pence Matthew G, DeMond Jaylee, Rudgers Gary
Simplot Plant Sciences, J. R. Simplot Company, Boise, ID, United States.
Front Bioeng Biotechnol. 2024 Jan 18;12:1354743. doi: 10.3389/fbioe.2024.1354743. eCollection 2024.
Small procedural changes in how regulatory agencies implement biotech policies can make significant differences in improving regulatory efficiency. This paper discusses how science based, crop specific guidance documents can improve dossier content and the review and approval of biotech varieties. In addition, we describe how the adoption of established risk assessment methodology and applying policy-linked decision making at the agency level can boost both efficiency and developer, public and government confidence in agency decision making and in biotech crops.
监管机构在实施生物技术政策时,程序上的微小变化就能在提高监管效率方面产生显著差异。本文讨论了基于科学的、针对特定作物的指导文件如何能改善生物技术品种档案的内容以及审评和审批情况。此外,我们还阐述了采用既定的风险评估方法并在机构层面应用与政策相关的决策如何既能提高效率,又能增强开发者、公众以及政府对机构决策和生物技术作物的信心。