Abstract: As an emerging drug delivery system, lipid nanoparticle(LNP) has demonstrated potential of broad application in advanced therapies. In recent years, significant breakthroughs have been made with LNP in gene therapy, cell therapy and vaccines, particularly in the application of mRNA vaccines in providing an effective solution for combating the COVID-19 pandemic. This article reviews the composition, preparation methods, mechanisms of action of LNP, and its applications in advanced therapy medicinal products, focusing on the analysis of the marketed LNP products and their clinical applications, and the summary of the relevant regulatory requirements for LNP-based drugs from major regulatory agencies at home and abroad, aiming to provide some reference for the research and evaluation of such drugs.