What guidelines does the EMA provide for toxicological assessments?
The EMA has established a comprehensive set of guidelines that outline the requirements for toxicological assessments. These guidelines address various areas, including non-clinical safety studies, reproductive and developmental toxicity, carcinogenicity, and genotoxicity. By setting these standards, the EMA ensures consistency in the evaluation of drug safety across the EU. Moreover, these guidelines are continuously updated to reflect advancements in scientific understanding and technology, ensuring that toxicological assessments remain robust and relevant.
