Non-clinical: toxicology
The European Medicines Agency's scientific guidelines on toxicology help medicine developers prepare marketing authorisation applications for human medicines.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- Qualification of non-genotoxic impurities - Scientific guideline
- ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Scientific guideline
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides - Scientific guideline
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides - Scientific guideline
- 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
- Carcinogenic potential - Scientific guideline
- CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Scientific guideline
- Non-clinical assessment of the carcinogenic potential of human insulin analogues - Scientific guideline
- Carcinogenicity evaluation of medicinal products for the treatment of HIV infection - Scientific guideline
- ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline
- Risk assessment of medicinal products on human reproduction and lactation: from data to labelling - Scientific guideline
- Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications - Scientific guideline
- Need for assessment of reproduction toxicity of human insulin analogues - Scientific guideline
- Non-clinical testing for inadvertent germline transmission of gene transfer vectors - Scientific guideline
Other toxicity
Mechanistic studies
- Non-clinical evaluation of drug-induced liver injury (DILI) - Scientific guideline
- In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors - Scientific guideline
Dependence
- Non-clinical investigation of the dependence potential of medicinal products - Scientific guideline
- Background to the CPMP Position Paper on possible pre-clinical studies to investigate addiction and dependence/withdrawal related to the use of selective serotonin uptake inhibitors (SSRIs) - Scientific guideline
- Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions - Scientific guideline
Impurities
- ICH Q3D Elemental impurities - Scientific guideline
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
- Limitations to the use of ethylene oxide in the manufacture of medicinal products (human) - Scientific guideline
Other
- ICH S10 Photosafety evaluation of pharmaceuticals - Scientific guideline
- Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline
- Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products - Scientific guideline
- Use of phthalates as excipients in human medicinal products - Scientific guideline
- Use of methyl- and propylparaben as excipients in human medicinal products for oral use - Scientific guideline
Chemicals
- Carcinogenicity evaluation of medicinal products for the treatment of HIV infection - Scientific guideline
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides - Scientific guideline
- Investigation of chiral active substances (human) - Scientific guideline
- In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors - Scientific guideline
- Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline
- Genotoxic and carcinogenic potential of phenolphthalein - Scientific guideline
- Background to the CPMP Position Paper on possible pre-clinical studies to investigate addiction and dependence/withdrawal related to the use of selective serotonin uptake inhibitors (SSRIs) - Scientific guideline
- Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions - Scientific guideline
Biologicals
- Need for assessment of reproduction toxicity of human insulin analogues - Scientific guideline
- Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application - Scientific guideline
Advanced-therapy medicinal products
- Non-clinical studies required before first clinical use of gene therapy medicinal products - Scientific guideline
- Non-clinical testing for inadvertent germline transmission of gene transfer vectors - Scientific guideline
- Scientific requirements for the environmental risk assessment of gene-therapy medicinal products - Scientific guideline