摘要
目的促进企业对非处方药转换申报工作的理解和资料准备,促进非处方药转换评价工作的顺利进行。方法结合我国非处方药转换的政策要求,对药品评价中心给企业发送的111份非处方药转换《不予立卷通知书》的内容进行统计,分析目前企业申报非处方药转换资料中存在的主要问题,并提出改进建议。结果 111份《不予立卷通知书》中涉及各类问题较多,表现为资料缺如、不完整或不符合相关要求。由统计结果可见,综述资料和药学资料的问题均较突出,安全性研究资料也有较多问题。"其他"资料项主要涉及未报送电子文档问题,如不良反应资料、药品质量资料、最小销售单位样品、拟使用非处方药说明书,以及电子文档等。结论企业在非处方药转换申报中的资料缺如或不完整、不规范现象普遍,主要原因包括不了解有关政策、对政策理解不充分、实际经验不足、重视不够、态度马虎等,建议企业重视非处方药转换申报的资料准备工作,认真学习,积累经验,逐步改进。
Objective To promote enterprises＇ comprehension and data preparation to OTC switch application, and to promote the work of OTC switch smoothly. Methods According to the policy requirements of OTC switch, 111 ＂No Filing Notices＂ that CDR sent to enterprises about OTC switch application materials were analyzed, to identify the main problems on the OTC switch application materials, and propose recommendations for improvement. Results Various problems are involved in 111 ＂No Filing Notices＂, including the materials absence, incomplete or incompatible with the relevant requirements. From the statistics results, the problems of review data and pharmacy data are as outstanding as safety studies data. ＂Other item＂ is mainly related that the electronic document data is not submitted. Specific outstanding problems are as follows： adverse reaction information, drug quality data, the smallest sales unit sample, proposed OTC instructions, electronic documents, etc. Conclusion The problems of materials absence, incomplete or incompatible with the relevant requirements are common in enterprises, because the enterprises are not aware of relevant policies, or not fully understand policies, lack practical experience, pay inadequate attention, sloppy and so on. So we suggest the enterprises to pay more attention to the preparation of OTC switch application, be careless, and to conscientiously study, accumulate experience and gradually improve.
出处
《中国药物警戒》
2015年第10期618-622,共5页
Chinese Journal of Pharmacovigilance
