| 摘要: |
| 目的 进一步规范我国药用辅料在药品标签、说明书中的标注，保障公众用药安全、促进合理用药。方法 对比国内外相关法规规定，对我国药用辅料在药品标签及说明书中的标注问题提出完善的建议。结果 我国药用辅料在标签、说明书中标注的相关法律法规及技术指南体系尚需进一步完善。结论 建议我国相关法规规定做好顶层设计和统筹谋划，明确辅料定义和标注范围，制定相应的技术指南，使生产者易遵从、监管者可执行、使用者更安全。 |
| 关键词: 药用辅料 标签 说明书 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.12.030 |
| 分类号:R926 |
| 基金项目: |
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| Study on Declaration of Excipients in the Labelling and Package Leaflet of Medicinal Products |
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CHEN Lei
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Chinese Pharmacopoeia Commission, Beijing 100063, China
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| Abstract: |
| OBJECTIVE To further standardize declaration of excipients in the labelling and package leaflet of medicinal products, ensure the public safety and promote rational drug use. METHODS Domestic and foreign relevant rules and regulations were compared, and suggestions to improve declaration of excipients in the labelling and package leaflet of medicinal products were put forward. RESULTS Relevant regulations and technical guidance system still need further perfect in China. CONCLUSION The top-level design and overall planning is required to formulating relevant rules and regulations in China, the definition of excipient and the scope of declaration should be clearer, and corresponding technical guidelines should be formulated. |
| Key words: excipients labelling package leaflet |
