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CAT——欧洲药品管理局新成立的先进疗法委员会。

CAT--the new committee for advanced therapies at the European Medicines Agency.

作者信息

Celis P

机构信息

European Medicines Agency, London, United Kingdom.

出版信息

Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2010 Jan;53(1):9-13. doi: 10.1007/s00103-009-0998-y.

Abstract

The Regulation on Advanced Therapies (Regulation (EC) 1394/2007) establishes a new scientific committee, the Committee for Advanced Therapies (CAT), at the European Medicines Agency. The CAT is composed of experts in the field of Advanced Therapy Medicinal Products (ATMPs)--gene and cell therapy and tissue engineered products--and is responsible for the evaluation of the marketing authorisation applications for this novel class of products. The CAT is also involved in all scientific advice on ATMPs and in two new regulatory procedures for ATMPs, the classification and the certification procedures. The CAT will also play a key role in early contacts with developers of ATMPs.

摘要

《先进治疗方法条例》((EC) 1394/2007号条例)在欧洲药品管理局设立了一个新的科学委员会,即先进治疗方法委员会(CAT)。CAT由先进治疗用药品(ATMPs)领域的专家组成,这些领域包括基因和细胞疗法以及组织工程产品,其负责评估这类新型产品的上市许可申请。CAT还参与所有关于ATMPs的科学建议以及ATMPs的两项新监管程序,即分类程序和认证程序。CAT还将在与ATMPs开发者的早期接触中发挥关键作用。

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