In recent years, drug regulatory authorities in China have vigorously promoted the standardization of instructions for Chinese proprietary medicines, gradually phasing out the vague term “not yet clear.” For a long time, some instructions lacked sufficient risk warnings by using this term in sections such as adverse reactions and contraindications, potentially compromising patient safety. Now, policies require pharmaceutical companies to improve and update instructions based on post-market research and clinical data, clearly specifying key information including adverse reactions, contraindications, and precautions. This initiative not only enhances drug safety and transparency but also supports the internationalization and standardization of traditional Chinese medicine. Scientific and clear instructions enable doctors and patients to use Chinese proprietary medicines more rationally and safely, reflecting both respect for traditional practices and compliance with modern regulatory standards, thereby driving high-quality development of traditional Chinese medicine.
近年来，国家药监部门大力推动中成药说明书规范化，“尚不明确”这一模糊表述正逐渐退出历史舞台。长期以来，部分中成药说明书在不良反应、禁忌等项目中标注“尚不明确”，导致用药风险提示不足，患者安全存在隐患。如今，政策要求企业基于药品上市后研究和临床数据，对说明书内容进行完善与更新，明确标注不良反应、禁忌、注意事项等关键信息。这一举措不仅提升药品安全性和透明度，也有助于中医药走向国际化、标准化。科学、清晰的说明书让医生和患者能够更合理、安全地使用中成药，既体现了对传统中医药的尊重，也符合现代药品监管要求，真正推动中医药高质量发展。
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