Legal Framework for CRISPR Gene Editing Technology: Analyzing International Regulatory Approaches and Proposing Standards for Clinical Applications

The rapid advancement of CRISPR gene editing technology has revolutionized genetic research and therapeutic applications, presenting unprecedented opportunities alongside significant regulatory challenges. This comprehensive review examines the current international regulatory landscape governing CRISPR technology, with particular focus on clinical applications and the intersection of scientific advancement with legal frameworks. The study analyzes regulatory approaches across major jurisdictions, including the United States, European Union, China, and other key nations, highlighting disparities in oversight mechanisms and identifying critical gaps in existing frameworks. Through systematic analysis of legislative documents, policy papers, and clinical trial protocols, this review identifies key challenges in harmonizing international standards while maintaining scientific innovation and ensuring public safety. The research reveals significant variations in how different jurisdictions address crucial aspects such as safety requirements, ethical considerations, and clinical trial oversight. Particular attention is given to the aftermath of significant events like the He Jiankui incident, which prompted regulatory reforms and highlighted the need for more robust oversight mechanisms. The study also examines emerging legal challenges, including intellectual property disputes, liability considerations, and human rights implications of gene editing technologies. The findings indicate a pressing need for harmonized international standards in clinical applications, particularly regarding safety protocols and risk assessment procedures. Key recommendations include establishing unified technical standards, enhancing cross-border collaboration mechanisms, and developing comprehensive frameworks for long-term monitoring of genetic modifications. This review contributes to the ongoing dialogue about appropriate governance mechanisms for emerging biotechnologies by proposing concrete steps toward international regulatory harmonization while acknowledging the need to balance innovation with safety and ethical considerations. The conclusions emphasize the importance of developing flexible yet robust regulatory frameworks capable of adapting to rapid technological advancement while maintaining rigorous safety standards and ethical oversight.