The ICH S12 Guideline Reaches Step 4 of the ICH Process

17 March 2023 – the ICH announced the ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” reached Step 4 on 14 March 2023.

This Guideline is intended to provide guidance on the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products that mediate their effect by the expression (transcription or translation) of transferred genetic materials, and harmonized recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles.

A Step 4 Introductory Training Presentation has been developed by the S12 EWG to summarize the content of the Guideline.

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