ICH: safety

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).

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Nonclinical safety in paediatric medicines


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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