Abstract: Objective To provide references for the management of safety information in prescription drug labeling in China. Methods By consulting regulations and literatures, format requirements and revision procedures of safety information in prescription drug labeling were compared among China, the United States and Japan. Results Compared with the United States and Japan, content and format requirements in Chinese regulations and guidelines for the safety-concerning sections of prescription drug labeling were relatively brief,and the implementation was too flexible. The revision process and notification after revision lack detailed basis for implementation. Conclusion It is suggested that both foreign and domestic experts should be widely consulted in combination with the experience of other countries. The safety information management system of the labeling could be further improved based on a comprehensive revision of the“Provisions on the Administration of Pharmaceutical Directions and Labels”and its detailed rules.

Key words: prescription drugs, labeling, safety information, revision