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).

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

Carcinogenicity studies

Genotoxicity studies

Toxicokinetics and pharmacokinetics

Repeat-dose toxicity

Reproductive toxicology

Biotechnological products

Safety pharmacology studies

Immunotoxicology studies

Therapeutic area-specific

Photosafety evaluation