Abstract: Objective To ensure safety of medication, exercise a more rigorous control over drug safety, promote the improvement of China’s drug traceability coding system, and bring about effective traceability throughout the drug supply chain. Methods By studying the legislations and standards for drug traceability coding systems and related literature at home and abroad, the process of establishing China’s drug traceability coding system and various constraints were elaborated. Based on the experience related to drug traceability coding systems in the United States, the European Union, and Canada, ways were recommended to boost the improvement of China’s drug traceability coding system. Results and Conclusion Based on the legislations and regulations in place in China and by learning from foreign systems, ways to improve the drug traceability coding system in China have been explored. The establishment of a uniform drug traceability code and specification of the legal responsibilities of code issuers are critical to improving China’s drug traceability coding system, which can contribute to risk control and effective supervision in the field of drug safety and promote standardized and legal regulation of drug safety so that human well-being can be guaranteed.

Key words: drug traceability code, coding system, drug safety, risk management and control, effective supervision