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).
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
Nonclinical safety in paediatric medicines