Clinical trials with advanced therapy medicinal products

被引：0
作者：
Schuessler-Lenz, M. [1 ]
Schneider, C. K. [2 ,3 ,4 ]
机构：
[1] Paul Ehrlich Inst, Abt Med Biotechnol, D-63225 Langen, Germany
[2] Paul Ehrlich Inst, Abt EU Kooperat Mikrobiol, D-6070 Langen, Germany
[3] Twincore Zentrum Expt & Klin Infekt Forsch, Hannover, Germany
[4] Europa Arzneimittelagentur EMEA, Ausschusses Neuartige Therapien, CAT, London, England
来源：
BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ | 2010年 / 53卷 / 01期
关键词：
Clinical trials; Good clinical practice; Advanced therapies; Marketing authorization; European Medicines Agency;
D O I：
10.1007/s00103-009-0984-4
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
For advanced therapies, the same basic principles for assessment apply as for any other biotechnological medicinal product. Nevertheless, the extent of data for quality, safety, and efficacy can be highly specific. Until recently, advanced therapies were not uniformly regulated across Europe, e.g., tissue engineered products were regulated either as medicinal products or medical devices. Thus, for some products no data from clinical studies are available, e.g., for autologous chondrocyte products. The draft guideline on Good Clinical Practice for clinical trials with advanced therapies describes specific additional requirements, e.g., ensuring traceability. Most clinical studies with advanced therapies in Germany are still in early phase I or II trials with highly divergent types of products and clinical indications. The Committee for Advanced Therapies (CAT) at the European Medicines Agency (EMEA) has been established to meet the scientific and regulatory challenges with advanced therapies.
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收藏
页码：68 / 74
页数：7
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