EMA发布修订的药物基因毒性检测指南文件

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修订的指南文件见附件 WC500119604[1].pdf (274.83 KB, 下载次数: 26)

2011-12-20 08:16 上传

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EMA的报道如下：

19/12/2011

European Medicines Agency issues revised guidance on genotoxicity testing of medicines

The European Medicines Agency has published a revised guideline on how pharmaceutical companies should test their medicines for damaging effects on the DNA.

The revised guideline sets out the state of the art in genotoxicity testing and is expected to improve the assessment of the risks of human medicines. The Agency also expects the implementation of the guideline to reduce the number of animals used in the testing of medicines and improve the efficiency of the medicine development process.

The guideline was adopted by the Agency's Committee for Medicinal Products for Human Use on 15 December 2011 and follows the core guideline harmonised between Europe, Japan and the United States of America by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

Damage to the DNA, or genotoxicity, is an important consideration for the developers of medicines and for medicines regulators, because it has the potential to cause irreversible changes to genes and even cancer. Rigorous testing of medicines is required to ensure that these risks are kept as low as possible for patients once medicines are on the market.
The revised guideline comes into effect in June 2012.