To give patients a more scientific instruction of prescription drugs, drug regulatory authorities in developed countries such as Europe, the United States, and Japan are actively promoting the establishment of patient labeling system. Unlike professional labeling, patient labeling uses easy-to-understand language to help patients understand the most critical information about the drug, thereby enabling safer use of prescription drugs. This article focuses on the U.S. Food and Drug Administration(FDA)′s patient labeling system, briefly introducing the main content and relevant requirements of different types of patient labeling, such as the medication guides (MG), patient package inserts (PPI), instructions for use (IFU), and consumer medication information (CMI). It also provides a detailed introduction to the scope of application, specific content, and format requirements of the patient medication information (PMI) that the FDA is currently promoting, while giving a brief explanation of the patient labeling systems of other drug regulatory authorities (such as the European Union and Japan). PMI is a new form of patient labeling further optimized by the FDA based on previous experience in patient labeling work, and it plans to gradually unify and replace the original MG and PPI. In China, the State Council issued and implemented the Law of the People′s Republic of China on the Construction of Accessible Environments in 2023, requiring drug manufacturers and operators to provide labels and instructions in accessible formats such as audio, large print, braille, and electronic versions. In the same year, the National Medical Products Administration (NMPA) issued a public notice to promote the pilot work on aging-friendly labeling. By sorting out and summarizing the practical experience of the FDA′s patient labeling system and comparing it with the current pilot work on aging-friendly labeling in China, this article provides insights and references for promoting the establishment of a patient labeling system in China.