| 张丽丽,江志杰,李响.药品说明书对药品检验机构确认标准的影响及建议[J].中国药事,2024,38(3):257-260 |
| 药品说明书对药品检验机构确认标准的影响及建议 |
| Influence of Drug Instructions on the Confirmation Standards of Institute forDrug Control and Suggestions |
| 投稿时间：2023-02-16 |
| DOI：10.16153/j.1002-7777.2024.03.003 |
| 中文关键词: 药品说明书 执行标准 修订 检验机构 工作建议 |
| 英文关键词: drug instructions executive standards revision institute for drug control work suggestions |
| 基金项目: |
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| 中文摘要: |
| 目的：为进一步完善药品说明书审评和备案提出合理化的建议。方法：从药品检验机构确认检验标准的角度，通过分析药品检验机构依据药品说明书确定执行标准时遇到的问题，结合个人工作经验和思考。结果：部分药品说明书载明的【执行标准】项缺少标准修订的提示性文件、未及时进行修订及存在书写不规范的情况。结论：建议企业及时准确地更新药品说明书，同时药监部门在日常监督工作中加强药品说明书的动态管理。 |
| 英文摘要: |
| Objective: To put forward reasonable suggestions for further improving the review and filing ofdrug instructions. Methods: From the perspective of confirming the inspection standards by institute for drugcontrol, the problems encountered by institute for drug control in determining the implementation standardsaccording to the drug instructions were analyzed, combined with personal work experience and thinking. Results:The [executive standards] item specifi ed in some drug instructions lacked the indicative documents for standardrevision, was not revised in time, and had non-standard writing. Conclusion: It is suggested that enterprisesshould update the drug instructions timely and accurately, and the drug supervision department should strengthenthe dynamic management of the drug instructions in the daily supervision work. |
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