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医疗机构制剂注册申报资料的常见问题及建议 被引量:4

The Problems on the Declared Date for Registration of Preparations in Medical Institutions and Corresponding Suggestions
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摘要 目的通过对注册申报资料进行审查分析,以药学为主从技术角度阐述医疗机构制剂现状及常见问题,促进医疗机构制剂向更规范的方向发展。方法对医疗机构制剂注册审评工作进行梳理、总结、归纳。结果与结论医疗机构制剂在弥补市场不足的同时也存在较多问题,应在各方共同努力下逐步完善、健全,以适应临床需要。 Objective Through the checkup and analyze of the declared date for registration,expatiated the actuality of preparations in medical institutions and familiar problems in the angle of technique mainly in pharmacy,accordingly to advance the canonical development of preparations in medical institutions.Methods The issues found in the checkup of the declared date for registration of preparations in medical institutions were summed up.Results and Conclusion Preparations in medical institutions still exists lots of problems although it made up the lack of market.It needs an active cooperation and collective efforts between departments concerned for those unsolved problems,and to adapt the need of clinic.
出处 《中国药事》 CAS 2011年第11期1100-1103,共4页 Chinese Pharmaceutical Affairs
关键词 医疗机构制剂 制剂注册 preparations in medical institutions preparation registration
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