Section II (PharmacoKinetic and Clinical Evaluation) on the clinical requirements of modified release products submitted as a line - extension of an existing marketing authorisation Points to consider on Xenogenic Cell Therapy Note for Guidance on Comparability of Medicinal Products containing biotechnology - derived proteins as active substance Note for Guidance on the use of medicinal products during pregnancy Note for Guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
Section II (PharmacoKinetic and Clinical Evaluation) on the clinical requirements of modified release products submitted as a line- extension of an existing marketing authorisation Points to consider on Xenogenic Cell Therapy Note for Guidance on Comparability of Medicinal Products containing biotechnology- derived proteins as active substance Note for Guidance on the use of medicinal products during pregnancy Note for Guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling