EMA Issues Revised Guidance on Genotoxicity Testing of Medicines
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 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.
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
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