ICH Publishes New Guidance on Pediatric Clinical Trials and Genomic Data

ICH Publishes New Guidance on Pediatric Clinical Trials and Genomic Data

Published on December 21, 2017

Author: Bhavesh Patel, C. Chem.

The ICH has published and adopted two new guidance documents relating to drug development.

The first document, an addendum to ICH E:11 entitled “Clinical Investigation of Medicinal Products in the Pediatric Population”, addresses new scientific and technical knowledge advances in pediatric drug development. The document updates certain aspects of the ICH E11 Guideline adopted in 2000. The amendment includes guidance on ethical considerations, age classifications and subgroups for children, pediatric formulations and guidance on extrapolation in pediatric drug development and trial design.

The second document, entitled “Guideline on Genomic Sampling and Management of Genomic Data”, addresses how genomic data should be collected in clinical trials and other studies to accord with certain methodologies during drug development and throughout the product life cycle. The guideline also covers the storage and retention of genomic samples.

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