CAJ | 학술논문

目的：厘清中国超说明书用药的规制环境。方法：文献综述与知情人深度访谈。结果：目前并无针对性的法律或法规，超说明书用药法律性质的界定难度很大。结论：加强超说明书用药管理，加强超说明书用药相关问题研究，以尽快推动超说明书用药立法。
목적：전청중국초설명서용약적규제배경。방법：문헌종술여지정인심도방담。결과：목전병무침대성적법률혹법규，초설명서용약법률성질적계정난도흔대。결론：가강초설명서용약관리，가강초설명서용약상관문제연구，이진쾌추동초설명서용약입법。
To analysis the regulation circumstance of the off-label use drug.Methods:In-depth interview were used in this study.Results:There are none regulation for the off-label use drug in China today;It is hard to know whether an off-label use drug is anti the regulation.Conclusion:The research on off-label use of drug should be strengthened and the legislation on it should be established rapidly.