【摘要】 目的:为医疗机构制剂新品种注册申报提供参考。方法:对2005年至2011年云南省医疗机构制剂申报情况及注册审评工作现状进行分析,总结申报资料中普遍存在的问题。结果与结论:目前医院制剂申报中普遍存在基础性试验资料不规范如处方及工艺研究不足,制剂质量控制存在隐患,不重视稳定性试验考察,缺乏药效学研究、毒性和安全性评价等情况。建议申报人通过加强科研协作、并按相关技术指导原则进行新品种注册申报工作。更多还原

【Abstract】 OBJECTIVE:To provide reference for the registration and declaration for pharmaceutical preparations in medical institutions. METHODS:The status quo of the registration and declaration for pharmaceutical preparations were analyzed in medical institutions of Yunnan province during 2005-2011. The common problems of registration dossier were summarized. RESULTS & CONCLUSIONS:The basic test data is not standardized in the declaration for pharmaceutical preparations in medical institutions, such as insufficient prescription and technology research,quality risk of preparation,neglected stability test,deficiency of pharma-codynamics study,toxicity and safety evaluation,etc. It is suggested to develop the registration and declaration for new pharmaceu-tical preparations by strengthening research collaboration and abiding by technical guidelines.更多还原