This topic was endorsed by the ICH Assembly in June 2019.
The ICH S12 Guideline reached Step 4 of the ICH process on 14 March 2023.
The ICH S12 Guideline:
- Provides harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products;
- Includes recommendations to facilitate the development of GT products while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/replace) principles;
- Makes recommendations for the overall design of nonclinical BD assessments.
Date of Step 4:
14 March 2023
Status: Step 5
Implementation status:
ANVISA, Brazil – In the process of implementation;
FDA, United States – Implemented; Date: 4 May 2023; Reference: 88 pg. 28565-28566
Health Canada, Canada – Implemented; Date: 21 July 2023; Reference: #23-105640-963
