近年來基因編輯技術的發展迅速，成為許多科學家及企業家關注的焦點，基因編輯技術應用於農業技術上，有助於開發植物新性狀，可以因應生物及非生物壓力的挑戰，亦能提高農作物產量、營養成分及收穫後儲藏能力，解決氣候變遷與糧食危機的隱患，促進環境生態及生物多樣性的維護，有助達成永續發展的目標。
由於基因編輯產品可能與傳統作物或基因改造生物難以區別，因此如何管理基因編輯產品，給世界各國主管機關帶來新的考驗，本文分析目前歐盟及阿根廷、巴西、智利、加拿大、美國、澳洲及紐西蘭、日本與英國等已建立或正在建立的基因編輯產品管理的法規制度，發現國際管理的趨勢逐漸轉向務實之產品導向管理模式。本文亦借鏡其他國家的作法，探討最佳實踐的管理模式，應具備明確法律定義、產品導向模式、分級彈性管理、鼓勵早期諮詢及公眾查詢機制等五大要件。同時本文一併探討我國現行基因改造生物的管理制度是否適合管理基因編輯產品，以及分析我國應該採取何種措施以因應挑戰。針對我國法制，本文建議應儘速修正基因改造技術之法律定義，並將新穎性食品管理法制化，提升其授權位階。同時，應建立跨部會之早期諮詢程序與公眾查詢資料庫，以確保食品安全兼顧消費者知情權，營造具國際競爭力之生技創新環境。
本文強調政府職能宜由單純之技術守門人，轉化為前瞻性之創新環境營造者，以應對氣候變遷與糧食安全之挑戰。

Recent years have witnessed the rapid advancement of gene-editing technologies, which have become a central focus for scientists and entrepreneurs worldwide. In agriculture, gene editing enables the development of crops with enhanced resistance to biotic and abiotic stresses, higher yields, improved nutritional value, and extended post-harvest shelf life. These innovations offer promising solutions to climate change and food insecurity while supporting environmental sustainability and biodiversity, thereby contributing to the United Nations Sustainable Development Goals (SDGs).
Because gene-edited products are often indistinguishable from conventional crops or genetically modified organisms (GMOs), their regulation presents new challenges. This paper examines the regulatory frameworks for gene-edited products that have been established or are under development in the European Union, Argentina, Brazil, Chile, Canada, the United States, Australia, New Zealand, Japan, and the United Kingdom. The findings indicate a global shift toward a pragmatic, product-based approach. Drawing upon international best practices, this study identifies five key elements of an optimal regulatory framework: clear legal definitions, a product-based approach, tiered and flexible management, the promotion of early-stage consultation, and the establishment of public inquiry systems. Simultaneously, this study evaluates the suitability of Taiwan's current GMO regulatory system for governing gene-edited products and analyzes the necessary measures to address future challenges.
Regarding Taiwan’s legal framework, this paper recommends promptly revising the legal definition of genetic modification technology and codifying the management of "novel foods" to enhance their statutory authority. Furthermore, it proposes the establishment of a cross-agency early-stage consultation mechanism and a public inquiry database to ensure food safety while balancing the consumers’ right to know. These measures would help foster an internationally competitive environment for biotechnological innovation. This paper concludes that the role of government shall evolve from a technological “gatekeeper” into a proactive “architect” of an innovation-oriented regulatory environment.

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