ICH Considerations: general principles to address virus and vector shedding - Scientific guideline

This document provides recommendations for designing non-clinical and clinical virus/vector shedding studies. In particular, it emphasizes the analytical assays used for detection and considerations for the sampling profiles and schedules in both non-clinical and clinical studies. The interpretation of non-clinical data and its use in designing clinical studies is also within the scope of this paper, as well as the interpretation of clinical data in assessing the need for virus/vector transmission studies.

Keywords: Gene therapy medicinal products, gene therapy, shedding, analytical assays, non-clinical, clinical

Current version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use considerations: General principles to address virus and vector shedding

Adopted Reference Number: EMEA/CHMP/ICH/449035/2009