ICH: safety

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The European Medicines Agency publishes guidelines on the safety of medicines that are harmonised between Europe, Japan and the United States of America by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

If you have comments on a document which is open for consultation, use the form for submission of comments on scientific guidelines.

For a complete list of scientific guidelines currently open for consultation, see Public consultations.


Carcinogenicity studies


Genotoxicity studies


Toxicokinetics and pharmacokinetics


Repeat-dose toxicity


Reproductive toxicology


Biotechnological products


Safety pharmacology studies


Immunotoxicology studies


Therapeutic area-specific


Photosafety evaluation

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