试论新《药品管理法》的特点

On Features of New Drug Administration Law

通过分析《药品管理法》的特点 :实行GMP和GSP制度 ,加强药品质量的规范管理 ;简化与规范药品的审批程序 ,取消地方药品标准 ;建立处方药与非处方药分类管理制度 ;加强了对药品监督管理部门和药品检验机构的监督。得出结论 ,新法体现科学、规范的现代管理思路 ,具有鲜明的时代特征。最后指出 ,随着新法的实施 ,必将开辟我国药事管理工作的新纪元。

Through an analysis of the features of the new Drug Administration Law , which include the execution of GMP and GSP systems, the standardized administration of drug quality, the simplification of the procedures in the examination and approval of standard drugs, the abolishment of local drug standards, the establishment of separate administration systems for prescription drugs and non-prescription drugs, and the supervision on drug supervision and examination departments, the authors draw the conclusion that the new law reflects the scientific and standardized management mode, with distinct characteristics of our time. The author also point out that with the implementation of the new law, a new era has begun in the management of medicines in our country.