药品管理法修订背景下医疗机构制剂监管创新与完善  

Innovation and Improvement of the Supervision of Pharmaceutical Preparations in Medical Institutions in the Context of Drug Administration Law Revision

作　　者：霍增辉[1] Huo Zenghui(Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学,北京100029

出　　处：《中国药事》2020年第5期514-519,共6页Chinese Pharmaceutical Affairs

摘　　要：目的:分析修订的《药品管理法》在医疗机构制剂监管上的创新,为医疗机构制剂监管完善提供建议。方法:查阅相关文献和法规,结合我国医疗机构及医疗机构制剂行业现状,对医疗机构制剂监管进行评析。结果:修订后的《药品管理法》的实施对医疗机构制剂发展将产生积极影响,其内容涵盖简化审批程序、修改调剂使用原则、细化和强化过程监管、完善法律责任。结论:修订的《药品管理法》在医疗机构制剂监管方面有创新性的制度设计,但与之衔接的下位规章需进一步修订、完善。Objective: To explore the innovative features of the revised Drug Administration Law in the supervision of pharmaceutical preparations of medical institutions and provide insights for the improvement of the supervision of pharmaceutical preparations in medical institutions. Methods: By reviewing the relevant literatures and investigating the current situation of pharmaceutical preparations in medical institutions, supervision and administration of pharmaceutical preparations in medical institutions were discussed and assessed. Results: Implementation of the revised Drug Administration Law will have a positive impact on the development of pharmaceutical preparations in medical institutions, including simplification of the approval process, revision of the principles for the use of dispensers, refinement and strengthening of process regulation and improvement of legal responsibilities. Conclusion: Revised Drug Administration Law has various innovative features for the supervision of pharmaceutical preparations in medical institutions, but the supporting documents and guidelines shall be further revised and improved accordingly.

关 键 词：医疗机构制剂 监管 创新 完善 

分 类 号：R95[医药卫生—药学]