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【BMJ:news(编译）英国药品监督体制改革】
上周，政府出台一项新政策，那就是禁止药品监督人员与制药厂有牵连。这项措施的目的在于增强公众的信心，提高药品监督质量，促进制药厂之间公平竞争。
作为英国卫生部门的负责人，Norman Warner说：政府已经注意到了医疗健康产品监督委员会的批评，批评呈暗示：这个机构是“制药厂的钱袋”。
虽然反对这种指责，但Mr Warner 说：医疗机构及一些规章制度自1968年来变化不大，现在是进行调整的时候了。
集药品监督和医疗行政职责为一身的机构将要产生，目的在于为药品安全性、有效性提供宝贵意见。
十八成员中包括两名外行，但没有制药公司的代表，专家组成员中吸收两名患者代表参与。Mr Warner 说：我们这样做的目的在于调动患者与广大公众积极性，参与药品安全监督的行列中。
委员会中的成员包括药物安全性有效性监督成员和专家组成员必须无私、公正。所有成员必须保证：除了获取其他利益外，其本人与直系亲属和制药厂也无直接或间接的经济利益。
原文如下：UK government tightens rules for drug regulators
Kathryn Godfrey London
Drug regulators will be barred from having any links to the pharmaceutical industry under new measures announced last week. The proposals are designed to increase public confidence in the monitoring of the safety of medicines and to encourage drug companies to be more open.
Norman Warner, health minister for England, said that the government was aware of the criticism of the Medicines and Healthcare Products Regulatory Agency which suggested that the agency was "in the pockets of the industry."
Although refuting this position, Mr Warner said that, as the advisory committee structure for medicines regulation has remained unchanged since 1968, it was time for change.
A new commission will be formed to advise ministers on the safety and effectiveness of medicines combining the responsibilities of the Medicines Commission and the Committee on Safety of Medicines.
The 18 member strong commission will include two lay representatives and no industry member. Expert advisory groups will also include patient representation.
Mr Warner said, "We want to give patients and the public a greater role in advising on safety of medicines by including strong lay and patient representatives."
Members of the commission, likely to be named the Commission on the Safety and Efficacy of Medicines, and of the advisory groups, will have to prove impartiality. Mr Warner said, "It is time to respond to concerns that the arrangements concerning declaration of interests are not as wide ranging as they could be."
Members will have to prove that they have neither a direct nor an indirect financial interest in the pharmaceutical industry as well as declaring any other interests, including those of their immediate family.
希望通过以上的了解，能给我们国家的药品管理方面提供一些帮助！
原文连接如下： http://bmj.bmjjournals.com/cgi/content/full/329/7476/1203-b 谢谢zhxf2003战友参与
可否加个合适的标题，点edit可进入编辑。 好的。
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作者:admin@医学,生命科学 2010-10-23 05:11
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