With the rapid development of Phase I clinical trials and bioequivalence trials （BE trials） in China， the scale of clinical research targeting healthy subjects/participants continues to expand. However， its management faces multiple challenges such as insufficient risk assessment， non-standardized processes， and inadequate communication， which directly impact subject safety and the quality of trial data. To better construct the Phase I/BE clinical trial ecosystem， standardize and strengthen the management of healthy subjects/participants， protect their rights and safety， and ensure that clinical trial data is scientific， authentic， and reliable， the Guangdong Pharmaceutical Association organized experts to develop the "Expert Consensus on the Management of Healthy Subjects/Participants in Phase I/BE Clinical Trials" based on a comprehensive analysis of practical experience. Addressing the group characteristics of healthy subjects/participants， specific implementation suggestions are proposed throughout the entire process of recruitment management， duplicate checking and medical history inquiry， communication and education， daily management of Phase I wards， privacy and information protection for healthy subjects/participants in Phase I/BE clinical trials. It emphasizes that healthy subjects/participants are important contributors to clinical trials， and efforts should be made to actively promote the interconnection and interoperability of subject duplicate checking systems， explore the application of artificial intelligence， electronic monitoring， and other technologies in subject management， and continuously optimize the "subject/participant-centered" management model. This consensus aims to provide reference for the implementation of Phase I/BE clinical trials and the standardized management of healthy subjects/participants， supporting the high-quality development of clinical research for innovative drugs in China.