Annex on Non- Clinical and Clinical Considerations Note for Guidance on the Non- Clinical Documentation of Medicinal Products with Well- Established Use Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre- clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
Annex on Non-Clinical and Clinical Considerations Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre-clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals