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药物评估:英国模式。

Drug assessment: UK style.

出版信息

Drug Ther Bull. 2013 Dec;51(12):141-4. doi: 10.1136/dtb.2013.12.0225.

Abstract

Before medicines can be marketed in the UK, they are subject to a system of licensing and the granting of a marketing authorisation that describes the conditions and patient groups for which the medicinal product can be used within the terms of its licence.(1) The licensing process involves an assessment of data relating to the efficacy, safety and quality of the product. However, the marketing authorisation does not determine whether, or how, it will be used in clinical practice. In the UK, the National Institute for Health and Care Excellence (NICE), the Scottish Medicines Consortium (SMC) and the All Wales Medicines Strategy Group (AWMSG) publish recommendations on the use of medicines for health services in the United Kingdom. In this article we review their remit, work processes and the status of guidance published in England, Scotland, Wales and Northern Ireland.

摘要

药品在英国上市之前,需经过许可制度并获得上市许可,该许可会描述药品在其许可条款范围内可用于的条件和患者群体。(1)许可过程涉及对与产品疗效、安全性和质量相关数据的评估。然而,上市许可并不决定药品在临床实践中是否会被使用以及如何使用。在英国,国家卫生与临床优化研究所(NICE)、苏格兰药品联盟(SMC)和全威尔士药品战略小组(AWMSG)会发布关于英国医疗服务中药品使用的建议。在本文中,我们将审视它们的职责范围、工作流程以及在英格兰、苏格兰、威尔士和北爱尔兰发布的指南的情况。

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