What ICH S12 - Nonclinical Biodistribution Considerations for Gene Therapy Products (2023) requires
ICH Guideline S12 (finalized September 2023, Step 4) establishes the nonclinical biodistribution study design principles for gene therapy products, specifying when biodistribution studies are required, acceptable animal models and tissue sampling approaches, integration of biodistribution data with pharmacology and toxicology studies, evaluation of germline transmission risk, and the use of biodistribution data to support clinical dose selection and patient monitoring; S12 applies to all gene therapy products including viral vectors, non-viral delivery systems, ex vivo gene-modified cell therapies, and gene editing approaches when submitted to ICH member regulatory agencies (FDA, EMA, PMDA).
Pillar: Biotech & Genomics · Authority: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Safety Working Party (S-WP) · Version: 2023-09 · Last updated:
Primary source: https://www.ich.org/products/guidelines/safety/safety-single/article/s12.html
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Primary Citations — 6 traced to source
- {"title":"ICH Guideline S12 - Nonclinical Biodistribution Considerations for Gene Therapy Products (Step 4, September 2023)","url":"https://www.ich.org/products/guidelines/safety/safety-single/article/s12.html","section":"Section 3 - When biodistribution studies are required; Section 4 - Animal model selection; Section 6 - Germline transmission assessment; Section 8 - Clinical translation of biodistribution data","instrument_type":"International Guideline"}
- {"title":"FDA Guidance for Industry: Long Term Follow-Up After Administration of Human Gene Therapy Products (January 2020)","url":"https://www.fda.gov/media/113768/download","section":"Section IV - Recommendations for LTFU study design including integration site monitoring; 5-year minimum follow-up period for integrating vectors","instrument_type":"FDA Guidance Document"}
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