Our understanding of DNA structure and how it interacts with the environment to give form and function at the organism level is growing at an unprecedented pace which shows no sign of slowing. These developments have already led to many new products and will continue to underpin as yet unpredicted future developments in biotechnology. However, this potential will not be realised unless the mechanisms for risk assessment, regulatory approval, product claims and labelling etc. are fit for purpose, have the confidence of all stakeholders and are sufficiently agile to support this rapidly changing field. The sectors that are making particular advances in biotechnological processes include agriculture, pharmaceuticals, food, chemical and human diagnostics and therapeutics. In many of these areas the research, investment and innovation pipeline is operating well as evidenced by the many marketed products. However, developments in plant breeding methods have posed particular challenges for regulators which in turn is stifling R&D and innovation, particularly in the EU. In rapidly moving areas of research and development, it is imperative that regulatory frameworks are future-proofed by design.

中文翻译：

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快速发展的生物技术的面向未来的法规。

我们对DNA结构及其如何与环境相互作用以在生物体一级形成形式和功能的理解以前所未有的速度增长，这丝毫没有减缓的迹象。这些发展已经产生了许多新产品，并将继续为尚未预测的生物技术未来发展提供支持。但是，除非风险评估，监管批准，产品索赔和标签等机制符合目的，拥有所有利益相关者的信任并且足够灵活以支持这一快速变化的领域，否则这种潜力将无法实现。在生物技术过程中取得特殊进展的领域包括农业，制药，食品，化学和人类诊断与治疗。在这些领域的许多研究中，投资和创新渠道运作良好，许多上市产品证明了这一点。但是，植物育种方法的发展给监管机构带来了特殊的挑战，反过来又扼杀了研发和创新，特别是在欧盟。在快速发展的研究和开发领域，必须通过设计使监管框架适应未来发展。