关键词: 非处方药转换, 不予立卷, 问题分析, 建议

Abstract: 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.

Key words: OTC switch, no filing, issues analysis, suggestion