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# ICH Approves Gene Therapy S12 Guidance
- URL: https://www.fdaweb.com/ich-approves-gene-therapy-s12-guidance/
- Published: 2023-03-21T12:00:00.000Z
- Updated: 2026-09-14T18:21:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154025

The International Council for Harmonization approved 3/14 a guidance, *Nonclinical Biodistribution Considerations for Gene Therapy Products S12*, with harmonized recommendations for the conduct of such studies. The [document](https://database.ich.org/sites/default/files/ICH%5FS12%5FStep4%5FGuideline%5F2023%5F0314.pdf?ref=fdaweb.com) has recommendations for the overall design of nonclinical biodistribution assessments. Considerations for the interpretation and application of the biodistribution data to support a nonclinical development program and the design of clinical trials are also provided.

The guidance contains Introduction, Definition of Nonclinical Biodistribution, Timing of Nonclinical Biodistribution Assessment, Design of Nonclinical Biodistribution Studies, Specific Considerations, Application of Nonclinical Biodistribution Studies, Notes, Glossary, and References.