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)
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ICH: Safety
Published by EMAInternational Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Safety Pharmacology StudyBiotechnological ProductReproductive ToxicologyRepeat-Dose ToxicityToxicokinetics and PharmacokineticsGenotoxicity StudyCarcinogenicity StudyNonclinical Safety in Paediatric MedicineImmunotoxicology StudyTherapeutic Area-SpecificPhotosafety Evaluation