关于进一步做好中药材质量监管工作的通知
| 关于进一步做好中药材质量监管工作的通知 |
| 食药监办安[2011]64号 |
| 2011年05月03日 发布 |
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各省、自治区、直辖市食品药品监督管理局(药品监督管理局)，新疆生产建设兵团食品药品监督管理局： 近日新闻媒体报道了甘肃省岷县、陇西等地药农和商户用硫磺熏蒸当归等药材的现象，引发了社会较大反响。中药材的养殖、种植及加工关系到中药制剂以及中药饮片的质量安全，应引起各级食品药品监管部门的高度重视。为确保药品质量安全，现就进一步加强中药材质量监管相关工作通知如下： 一、进一步提高对中药材质量监管重要性的认识。各省（区、市）食品药品监管部门应通过甘肃岷县硫熏药材事件，举一反三、防微杜渐，拓宽监管思路，进一步加强中药材流通环节的监管，加强对中药材及中药饮片经营企业以及中药材专业交易市场硫熏药材的监督检查，加大市场抽样检验的力度，进一步规范中药材及中药饮片的经营销售行为。 二、强化中药制剂及中药饮片生产的监督检查。各省（区、市）食品药品监管部门应按照国家局《关于进一步加强中药生产监督检查的通知》（国食药监安〔2010〕457号）和国家局会同卫生部、国家中医药管理局联合下发的《关于加强中药饮片监督管理的通知》（国食药监安〔2011〕25号）的要求，加强对中药制剂及中药饮片生产企业购进中药材及中药饮片质量检验工作的监督，加大对中药制剂及中药饮片生产企业药品生产现场监督检查的力度。 三、加强中药材及中药饮片质量检验。国家局正在制定中药材及中药饮片二氧化硫残留量限度标准，在此之前，各省（区、市）食品药品监管部门应设定工作时限，要求辖区内中药制剂及中药饮片生产企业制定二氧化硫残留量限度指标，作为企业物料检测内控标准。凡企业未按要求制定二氧化硫残留物检测内控标准或不按照内控标准对购进中药材或中药饮片进行检验的，其中药材或中药饮片不得用于生产投料。 四、加强与相关部门的协调与配合。各省（区、市）食品药品监管部门应主动与农业、工商、卫生等部门加强信息沟通与交流，及时通报中药材养殖、种植及加工过程中出现的硫磺熏蒸以及其他影响药材质量的问题，并积极配合相关部门采取措施，齐抓共管，综合治理，切实履行监管职责，确保中药制剂及中药饮片质量安全。 各省（区、市）食品药品监管部门在中药材质量监管工作中发现的问题和情况，应及时向所在地省级人民政府和国家局报告。
联系人：郭清伍、翁新愚
电 话：010-88330852，88330812
传 真：010-88330854
国家食品药品监督管理局办公室
二○一一年五月三日
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相关链接：http://www.sfda.gov.cn/WS01/CL0844/61210.html
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