ICH: safety

The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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


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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