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
• Gene therapy
• 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 medicines

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
• ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals
• ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals

Gene therapy

• ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b - 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
• ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers - Scientific guideline
• ICH S3B Pharmacokinetics: repeated dose tissue distribution studies

Repeat-dose toxicity

• ICH S4 Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing)

Reproductive toxicology

• ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline

Biotechnological products

• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals

Safety pharmacology studies

• ICH S7A Safety pharmacology studies for human pharmaceuticals
• ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline

Immunotoxicology studies

• ICH S8 Immunotoxicity studies for human pharmaceuticals

Therapeutic area-specific

• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals

Photosafety evaluation

• ICH S10 Photosafety evaluation of pharmaceuticals