我国药品追溯码编码制度研究探讨

doi:10.19803/j.1672-8629.20230288

摘要/Abstract

摘要： 目的为保障用药安全,提升药品安全治理水平,促进完善我国药品追溯码编码制度,助力实现药品供应链全程有效追溯。方法通过检索、分析并研究国内外药品追溯码编码制度的立法规范与相关文献,阐述我国药品追溯码编码制度从雏形到确立的过程以及制约因素;参考美国、欧盟和加拿大药品追溯码编码制度的建设经验,提出促进完善我国药品追溯码编码制度的建议。结果与结论 立足于我国立法环境与监管实际,适当借鉴国外制度有益经验,探索改进药品追溯码编码模式、确立统一标准药品追溯码以及明确编码主体的法律责任是完善我国药品追溯码编码制度的可靠路径,有助于实现药品安全领域的风险管控与有效监管,推动药品安全管理工作科学化、规范化、法治化,进一步维护药品安全,保障公众健康。

关键词: 药品追溯码, 编码制度, 药品安全, 风险管控, 有效监管

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

中图分类号:

R951

马美英, 赵晓佩, 张梦瑶, 胡一琳. 我国药品追溯码编码制度研究探讨[J]. 中国药物警戒, 2024, 21(2): 167-172.

MA Meiying, ZHAO Xiaopei, ZHANG Mengyao, HU Yilin. Drug traceability coding system in China[J]. Chinese Journal of Pharmacovigilance, 2024, 21(2): 167-172.

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