中国药事
中國藥事
중국약사
CHINESE PHARMACEUTICAL AFFAIRS
2015年
4期
343-346
,共4页
药品管理法%修订建议%实施问题
藥品管理法%脩訂建議%實施問題
약품관리법%수정건의%실시문제
Drug Administration Law%revision suggestions%implementation issues
目的：探讨药品管理存在的问题，为《药品管理法》的修订提出参考建议。方法：归纳总结贯彻执行《药品管理法》具体实践中碰到的一些问题，从法律层面思考解决这些问题的思路，从而提出修订《药品管理法》部分内容的建议。结果与结论：建议从法律层面上健全政府、相关部门的药品监管责任体系及县级药品技术监督体系；增加药品使用单位使用药品的许可制度和质量管理规范；直接明确禁止使用假劣药品及补充按假劣药品论处的一些情形；完善相关法律责任，以解决“有法可依违法难究”的药品监管困难。
目的：探討藥品管理存在的問題，為《藥品管理法》的脩訂提齣參攷建議。方法：歸納總結貫徹執行《藥品管理法》具體實踐中踫到的一些問題，從法律層麵思攷解決這些問題的思路，從而提齣脩訂《藥品管理法》部分內容的建議。結果與結論：建議從法律層麵上健全政府、相關部門的藥品鑑管責任體繫及縣級藥品技術鑑督體繫；增加藥品使用單位使用藥品的許可製度和質量管理規範；直接明確禁止使用假劣藥品及補充按假劣藥品論處的一些情形；完善相關法律責任，以解決“有法可依違法難究”的藥品鑑管睏難。
목적：탐토약품관리존재적문제，위《약품관리법》적수정제출삼고건의。방법：귀납총결관철집행《약품관리법》구체실천중팽도적일사문제，종법률층면사고해결저사문제적사로，종이제출수정《약품관리법》부분내용적건의。결과여결론：건의종법률층면상건전정부、상관부문적약품감관책임체계급현급약품기술감독체계；증가약품사용단위사용약품적허가제도화질량관리규범；직접명학금지사용가렬약품급보충안가렬약품론처적일사정형；완선상관법률책임，이해결“유법가의위법난구”적약품감관곤난。
Objective:To put forward suggestions for revision of the Drug Administration Law by discussing the problems existing in medicine management. Methods: The problems which occurred in the actual situations during the implementation of the law were summarized and some suggestions were put forward to revise some parts of the content of the law from a legal aspect. Results and Conclusion:It is suggested that the drug supervision responsibility system of the government and the relevant departments as well as the drug technical supervision system at the county level should be improved from the legal aspect, the drug licensing system and quality management specifications be added during drug utilization, counterfeit and low-quality drugs be prohibited to use, some cases be supplemented where punishment will be done the same as how to do with the counterfeit and low-quality drugs, and the relevant legal liabilities be consummated in order to solve supervision difficulties in situations where there are laws to abide by while violations of the law are hard to deal with.
