The proposed concept paper is intended to be developed into a guideline which will replace the reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. The guideline will provide recommendations on the interface between predictive biomarker-based assays including CDx, and the development and lifecycle of a medicine.View this resource Bookmark this resource
EMAGuidelinePharmacogenomicsGenomic DataSample Coding
European Medicines Agency. ICH Topic E15. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (EMEA/CHMP/ICH/437986/2006). 2007.
This is a note for guidance on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing.View this resource Bookmark this resource
ICH S8 Guideline 2006. Note For Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Chmp/167235/2004).
EMAGuidelineVaccineToxicityAnimal ModelsNon-Clinical Testing
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on Adjuvants in Vaccines for Human Use. 2005 (EMEA/CHMP/VEG/134716/2004).
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Need for Non-Clinical Testing in Juvenile Animals of Pharmaceuticals for Paediatric Indications. 2008 (EMEA/CHMP/SWP/169215/2005).
Published by European Medicines Agency (EMA)EMAGuidelineAnimal ModelsNon-Clinical TestingJuvanile AnimalsPaediatric Indications
This document provides guidance on the need for, role and timing of studies in juvenile animals in the non-clinical safety evaluation of medicinal products for paediatric use. It is applicable to initial medicinal products applications and also to authorised medicinal products being further developed to include paediatric indications. It outlines potential safety concerns that cannot be adequately assessed in the adult population, in standard non-clinical studies, or in clinical trials.View this resource Bookmark this resource
European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998
Published by European Medicines Agency (EMA)EMAGuidelineVaccineClinical TrialsToxicityAnimal ModelsPharmaceuticals
European Medicines Agency. Committee for Medicinal Products for Human Use. ICH Guideline S11 on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals. Step 5. 31 March 2020. EMA/CHMP/ICH/616110/2018.
Published by European Medicines Agency (EMA)EMAGuidelineToxicityAnimal ModelsPharmaceuticals Non-Clinical TrialsPaediatrics
This guideline recommends an approach for the nonclinical safety evaluation of pharmaceuticals intended for development in paediatric populations. This can include products with prior adult use, as well as products being considered for initial human use in paediatricsView this resource Bookmark this resource