Regulatory Frameworks for Human Gene Editing: A Systematic Literature Review

Human gene editing technologies, especially CRISPR-Cas9, have advanced rapidly, raising complex regulatory, ethical, and scientific issues. This study reviews 47 peer-reviewed articles published between 2015 and 2025, following PRISMA 2020 guidelines. The analysis reveals major empirical, theoretical, methodological, and practical gaps in governance. It notes a lack of global harmonisation, weak ethical oversight, and inconsistent national policies that obstruct responsible innovation. Developing countries often lack enforceable guidelines, while developed nations use varied regulatory frameworks, leading to fragmentation. The study recommends a shared, participatory regulatory model, stronger international cooperation, and better integration of bioethics into policy-making. These steps are vital to ensure fair access, protect human dignity, and build public trust as gene editing moves into clinical and societal applications.