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Published on 20 December 2011

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EMA revises genotoxicity testing guidelines

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

The guidelines set out best practice in genotoxicity testing and are expected to improve the assessment of the risks of human medicines.

The Agency also expects the implementation of the guidelines to reduce the number of animals used in the testing of medicines and to improve the efficiency of the medicine development process.

The guidelines were adopted by the Agency’s Committee for Medicinal Products for Human Use on 15 December 2011 and follow the core guidelines harmonised between Europe, Japan and the USA by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

The revised guidelines come into effect in June 2012.

EMA


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