Non-clinical guidelines: toxicology
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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.
Genotoxicity
- Qualification of non-mutagenic impurities
- ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides
Carcinogenicity
- ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals
- 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
- Carcinogenic potential
- CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment
- Non-clinical assessment of the carcinogenic potential of human insulin analogues
- Carcinogenicity evaluation of medicinal products for the treatment of HIV infection
Reproductive/developmental and juvenile toxicity
- ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals
- Risk assessment of medicinal products on human reproduction and lactation: from data to labelling
- Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications
- Need for assessment of reproduction toxicity of human insulin analogues
- Non-clinical testing for inadvertent germline transmission of gene transfer vectors
Local tolerance
Immunotoxicity
Other toxicity
Mechanistic studies
- Non-clinical evaluation of drug-induced liver injury (DILI)
- In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors
Dependence
- Non-clinical investigation of the dependence potential of medicinal products
- 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)
- Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions
Impurities
- ICH Q3D Elemental impurities
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
- Limitations to the use of ethylene oxide in the manufacture of medicinal products
Other
- ICH S10 Photosafety evaluation of pharmaceuticals
- Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches
- Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products
- Use of phthalates as excipients in human medicinal products
- Use of methyl- and propylparaben as excipients in human medicinal products for oral use
Specific types of products
Chemicals
- Carcinogenicity evaluation of medicinal products for the treatment of HIV infection
- Assessment of the genotoxic potential of antisense oligodeoxynucleotides
- Investigation of chiral active substances
- In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors
- Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases)
- Genotoxic and carcinogenic potential of phenolphthalein
- 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)
- Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions
Biologicals
- Need for assessment of reproduction toxicity of human insulin analogues
- Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application
Advanced-therapy medicinal products