CAJ | 학술논문

目的：对我国药品使用环节现行法律法规进行剖析，为完善我国药品使用环节法律法规提供参考。方法对国家相关部门颁布的药品使用环节的现行法律法规进行分类、汇总和分析。结果我国现行药品使用环节立法规范工作虽然取得了一定成果，但仍存在着药事管理基本法中规定宽泛、缺乏统一立法、冲突较多、缺乏普遍适用性或强制力、监管执法主体职责设定不够清晰以及法律责任条款不明确和处罚措施不严厉等问题。结论应完善现行的法律法规，尤其在法律效力与责任方面，逐步形成满足安全、合理用药要求的较为成熟的药品使用管理法律法规体系。
목적：대아국약품사용배절현행법율법규진행부석，위완선아국약품사용배절법율법규제공삼고。방법대국가상관부문반포적약품사용배절적현행법율법규진행분류、회총화분석。결과아국현행약품사용배절입법규범공작수연취득료일정성과，단잉존재착약사관리기본법중규정관범、결핍통일입법、충돌교다、결핍보편괄용성혹강제력、감관집법주체직책설정불구청석이급법률책임조관불명학화처벌조시불엄려등문제。결론응완선현행적법율법규，우기재법률효력여책임방면，축보형성만족안전、합리용약요구적교위성숙적약품사용관리법율법규체계。
Objective To dissect China's existing laws and regulations in the drug use link,and provide suggestions for improving the laws and rules of drug use in China.Methods The current laws and rules of drug use issued by related government departments were collected,classified and analyzed.Results and Conclusion In spite of many legislative achievements in the use of drugs,there are still some problems in the basic laws of drug administration, including broadly-regulated rules, lack of conformity in legislation,too many conflictions,lack of general applicability or coercive power,ambiguities in the responsibility of regulation enforcement and legal terms,and too mild penalties,etc.The current laws and regulations should be improved,especially in the aspects of responsibility and the validity of law,so as to gradually build up a mature drug administration system to safeguard the rational use of drugs.