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药品监管与卫生技术评估。

Medicines regulation and health technology assessment.

机构信息

Medicines and Healthcare Products Regulatory Agency, London, UK.

出版信息

Clin Pharmacol Ther. 2010 Feb;87(2):152-4. doi: 10.1038/clpt.2009.261.

Abstract

Health technology assessment (HTA) is as important as regulation to allow patients access to new medicines, and there are demands that the two processes should be carried out more closely together in time. Although the methods used by the regulator differ from those used by the health technology assessor, there is scope for synergies that would be useful to both parties. By providing scientific advice to sponsors of new medicines, both regulators and health technology assessors can also provide support for drug innovation.

摘要

健康技术评估(HTA)与监管一样重要,它可以让患者获得新药,因此人们要求这两个过程应该更紧密地结合在一起。虽然监管机构使用的方法与健康技术评估人员使用的方法不同,但有协同作用的空间,这对双方都将是有益的。通过向新药的赞助商提供科学建议,监管机构和健康技术评估人员都可以为药物创新提供支持。

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