对药品不良反应应及时向当地药品监督管理部门报告。
Drug adverse reactions shall be duly reported to the local drug administration authorities.
已经生产或者进口的，由当地药品监督管理部门监督销毁或者处理。
Those already produced or imported shall be destroyed or disposed of under the supervision of the local drug regulatory department.
国外的药品召回制度及其实施经验是值得我国药品监督管理部门借鉴的。
Drug Recall System abroad experience and its implementation Worthy of the supervision and management department of China's drug reference.
第六十五条药品监督管理部门根据监督检查的需要，可以对药品质量进行抽查检验。
Article 65 drug regulatory departments may conduct selective testing of drug quality in light of the need of supervision and inspection.
目的了解当前医院各价格层次药品的使用情况，为医院及药品监督管理部门提供参考。
Objective To provide reference for drug administration by investigating and analyzing the using of drug in different price intervals in a general hospital.
县级以上地方(食品)药品监督管理部门负责本行政区域内医疗器械生产监督管理工作。
Each local (food) drug administration department at the county level or above shall take charge of supervising and administering the medical device production within its own jurisdiction.
第四十六条药品的标签、使用说明书必须与药品监督管理部门批准的内容、式样、文字相一致。
Article 46: drug labels and insert sheets (direction for use) shall be consistent with those approved by drug regulatory authorities in content, style and written language.
对于已经获准药品委托生产的，应当同时提交药品监督管理部门同意终止委托生产的相关证明性文件。
For drugs with approval of toll manufacture, relevant approval documents for the termination of toll manufacture issued by food and drug administrations shall be submitted simultaneously.
开办药品零售企业，须经企业所在地县级以上地方药品监督管理部门批准并发给《药品经营许可证》。
Any newly established drug retailer shall be subject to approval and be granted the above certificate by the local drug regulatory agency at or above the county level.
海关凭药品监督管理部门出具的《进口药品通关单》放行。无《进口药品通关单》的，海关不得放行。
The customs shall release the drugs on the basis of the drug Import Note issued by the said departments, and may not release those drugs for which no drug Import Note is issued.
药品监督管理部门对有证据证明可能危害人体健康的药品及其有关材料 可以采取查封、扣押的行政强制措施。
The drug regulatory agency shall take administrative enforcement to seal or seize the drugs and related materials proved to be potentially harmful to human health and shall.
第四十条药品必须从允许药品进口的口岸进口，并由进口药品的企业向口岸所在地药品监督管理部门登记备案。
Article 40 Drugs shall be imported via the ports where drug importation is permitted, and be registered by the drug importers with the local drug regulatory departments for the record.
委员会还确定了15 个新的参比制剂，采用全球计量标准，以指导生产厂商和药品监督管理部门开展生物药品工作。
The committee also established 15 new reference preparations, which are global measurement standards that guide manufacturers and regulatory authorities on the activity of biological medicines.
结果与结论：内标签内容存在项目不完善、印字模糊等不规范现象，医疗机构、制药企业、药品监督管理部门应高度重视注射剂内标签内容。
RESULTS & CONCLUSIONS: The problem lies in the labeling of injections manifested as incomplete of label items and fuzzy printing etc. Medical institutions, pharmaceut…
结果与结论：内标签内容存在项目不完善、印字模糊等不规范现象，医疗机构、制药企业、药品监督管理部门应高度重视注射剂内标签内容。
RESULTS & CONCLUSIONS: The problem lies in the labeling of injections manifested as incomplete of label items and fuzzy printing etc. Medical institutions, pharmaceut…
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