| 中药饮片警示说明 |
| 添加时间：2018/8/17 15:11:22 浏览次数： |
| 中药饮片警示说明 Warning notes for Chinese Herbal Pieces 国家食品药品监督管理总局发布了《关于修订含毒性中药饮片中成药品种说明书的通知》（以下简称《通知》）。根据这一文件，2013年年底前，产品中含有毒性药材的中药饮片企业，必须在说明书中写明毒性成分并添加警示语。 The State Food and Drug Administration (SFDA) has issued the Notice on Revising the Specifications of Chinese Patent Drugs Containing Toxic Chinese Herbs (hereinafter referred to as the Notice). According to the document, by the end of 2013, Chinese herbal medicine slice enterprises that contain toxic drugs in their products must include toxic ingredients and warnings in their instructions. 《通知》规定，凡处方中含有《医疗用毒性药品管理办法》（国务院令第23号）中收载的28种毒性药材制成的中药饮片（含有毒性的炮制品）的中成药品种，相关药品生产企业应在其说明书成分项下标明该毒性中药饮片名称，并在相应位置增加警示语：“本品含×××”。 "Notice" stipulates that the relevant pharmaceutical manufacturers shall indicate the name of the toxic Chinese herbal decoction pieces (processed products containing toxic substances) in the prescriptions containing 28 kinds of Chinese herbal medicine pieces (processed products containing toxic substances) contained in the "Measures for the Administration of Toxic Drugs for Medical Use" (Order No. 23 of the State Council), and Add warning words in the corresponding position: "this product contains * x *". 《通知》明确提出，处方中含有其他已被证明具有毒性、易导致严重不良反应的中药饮片的中成药品种，相关药品生产企业也应按照上述要求修订说明书。值得注意的是，涉及国家秘密技术的中成药品种也适用这一新规定。 The Notice clearly states that the prescriptions contain other Chinese patent medicines which have been proved to be toxic and prone to serious adverse reactions. The relevant pharmaceutical manufacturers should also revise the instructions according to the above requirements. It is worth noting that this new regulation is also applicable to the varieties of proprietary Chinese medicines involving state secrets. |
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