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This Guidance is divided into three parts, including toxicity assessment, developmental and reproductive toxicity testing, and reproductive toxity classification criteria, aiming to provide stakeholders a detailed description of reproductive toxicity evaluation and classification criteria, and help them better face the hazard review by the authority.
I. Toxicity assessment
Definition of toxicity
Interpretation of toxicity data
No observed adverse effect level (NOAEL)
II. Developmental and reproductive toxicity testing
Construction of ICH guidelines and principles of developmental toxicity testing
Test design
Fertility and reproduction evaluation technique
Embryo – fetal development
Final assessment
Prenatal and postnatal development study
Toxicokinetics
Developmental toxicity test in rodents and rabbits
Reproductive and developmental assessments of primates
Alternative techniques for reproductive and developmental toxicity test
Conclusions and study directions for alternative test methods
III. Reproductive toxicity classification criteria
Criteria for adverse effects on reproductive toxicity
Classification of chemical substances according to reproductive toxicity
Classification of mixtures according to reproductive toxicity
