药品召回

美国药品召回制度对我国药品安全的启示

Enlightenment of American Drug Recall System on Drug Safety in China

国内外药品召回制度比较研究

Comparative study on the domestic and foreign drug recall system

FDA的检查官发现它的一些质量控制数据是伪造的，随后发生的药品召回事件是FDA历史上最大的药品召回事件之一。

FDA inspectors found that some of its quality-control data had been falsified , leading to one of largest drug recalls in FDA history .

FDA从来没有命令药品召回，其下的咨询委员会也没有建议对万络重返市场设置阻碍。

The FDA never ordered the drug withdrawn and a subsequent Advisory Committee did not recommend that Vioxx should be barred from returning to market .

生产企业是药品召回实施的主体和召回成本的承担者。

Drug manufacturers are the subject of recall and bearing the total recall costs .

基于药品召回的医药逆向物流体系的建立

To Develop the System of the Pharmaceutical Reverse Logistics Based on the Recall of Drug

前言：目的：为我国建立药品召回制度提供参考。

OBJECTIVE : To provide references for the establishment of drug recall system in China .

目的完善药品召回制度，培育药品生产企业的诚信自律意识。

Objective Perfecting the drug recall system will cultivate credit and self-disciplinary awareness of production enterprises .

美国药品召回制度的启示与借鉴

Enlightenment of American Drug Recall System

方法：通过对美国药品召回制度的介绍，探讨其对我国药品安全的启示。

METHODS : Through introducing the drug recall system in U.S. , we could get enlightenments from it for our drug safety .

结合中美史克公司召回康泰克的经验，浅谈企业药品召回管理规范的制定。

Based on the experience of GSK of their recalling of Contact Capsules , The authors discussed the establishment of recalling Practice of pharmaceutical manufacturers .

当我国已建立起药品召回制度并经历了初级阶段后，这时应实行自愿召回为主、强制召回为辅的药品召回制度。

When the drug recall system has established and experienced the primary period , we should implement the system with main voluntary recalls and mandatory recalls .

面对巨额的药品召回成本，企业难免望而却步，而这将不利于药品召回的发展与完善。

Facing massive cost of drug recall , pharmaceutical manufacturers are discouraged inevitably , which will be detrimental to the development and improvement of drug recall .

通过对上述事件的分析探讨目前我国建立药品召回制度必要性、可行性以及实施障碍以及为我国医药企业建立自身的召回制度提供借一鉴。

The necessity , feasibility and implementation obstacle for establishing the drug recall system were discussed and the corresponding suggestions were raised by analyzing the above events .

结果与结论：我们可借鉴美国的药品召回制度，完善我国的法律规范体系，全面推行药品召回制度。

Results & conclusion : we could refer to the drug recall system in U.S.and perfect our law system as well as carry out our drug recall system .

药品召回是生产企业对已上市销售并存在安全隐患的缺陷药品的回收，能避免缺陷药品在市场上的继续流通，减少其可能造成的健康损害。

Drug recall by pharmaceutical manufacturers is a measure of recycling the drugs that have been marketed and have safety problems , to avoid the defect drugs continue to circulate in the market and reduce the potential health damage .

在药品召回钱有400多人有严重的副作用，6个月前被召回的药会导致不正常发育，这种医疗器械是供心脏有缺陷的患者使用了，结果导致8人死亡。

Over 400 people had terrible side effects before this drug was recalled , and a drug recalled six months ago causes birth defects . Here 's a medical device for people with heart problems that 's defective and eight people died as a result .

国内关于逆向物流管理研究少之又少，但逆向物流这一经济现象在我国却时有发生，例如时下频繁的汽车召回、药品召回和废旧产品的回收再利用等。

In our country , the concept was introduced later , and less research about the reverse logistics was done , but this economic phenomenon occurs from time to time , such as the car recall , the medicine recall and the recovery and reuse of waste materials .

那么，Suzanne为过去有那么多药品器械被召回感到担心；

Well , Suzanne is worried about the drugs and medical devices that have been recalled in the past year ;

药品制造商必须负责召回工作，并且需要对药品受害者负责。

The drug manufacturer must take responsibility for the recall , and can be held liable if anyone is harmed by the drug .

不过，若国家质检总局在惠普问题上做出决定，将设定一个新的先例，因为中国法律迄今仅对汽车、食品、药品和玩具的召回规定了明确规则。

A decision in the HP case would set a new precedent , however , as Chinese law so far has clear rules only for recalls of cars , food products , drugs and toys .

：别这么确定，我正在读有关药品收到污染的报道，在药品召回前，药品导致了13人死亡。

Suzanne : Don 't be so sure . I 'm just reading about this drug that was contaminated and before it was recalled , it caused 13 deaths .

目前，针对缺陷药品世界上许多国家为了保障患者的利益已经建立了药品召回制度，并取得了良好效果。

At present , many countries have established drug recall system for the social public 's benefits and got good effect .

药品的安全问题是全社会关注的焦点问题之一，尽快完善药品召回制度是建立我国药品安全监管长效机制的应有之义。

The safety of drugs arouses attentions from the whole society . To perfect the drug recalling system plays a necessary part in setting up our long term drug safety supervision mechanism . The United States established the earliest drug recalling system .