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).
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
- ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 - Scientific guideline
Carcinogenicity studies
- ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals - Scientific guideline
- ICH S1A Need for carcinogenicity studies of pharmaceuticals - Scientific guideline
- ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline
- ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals - Scientific guideline
Genotoxicity studies
- ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Scientific guideline
Toxicokinetics and pharmacokinetics
- ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - Scientific guideline
- ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers - Scientific guideline
- ICH S3B Pharmacokinetics: repeated dose tissue distribution studies - Scientific guideline
Repeat-dose toxicity
- ICH S4 Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing) - Scientific guideline
Reproductive toxicology
- ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5 - Scientific guideline
Biotechnological products
- ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals - Scientific guideline
Safety pharmacology studies
- ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline
- ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline
Immunotoxicology studies
Therapeutic area-specific
Photosafety evaluation