ICH considerations : General Principles to Address the Risk of Inadvertent Germline Integration of Gene Therapy Vectors
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_General_Principles_Risk_of_IGI_GT_Vectors.pdf
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
https://www.fda.gov/media/91425/download
Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines (EMA/CHMP/VWP/141697/2009)
https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-live-recombinant-viral-vectored-vaccines_en.pdf
ICH considerations : Oncolytic Viruses
https://admin.ich.org/sites/default/files/2019-04/ICH_Considerations_Oncolytic_Viruses_rev_Sep_17_09.pdf
Questions and answers on the principles of GMP for the manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs
https://www.ema.europa.eu/en/documents/other/questions-answers-principles-gmp-manufacturing-starting-materials-biological-origin-used-transfer_en.pdf
Human Gene Therapy for Rare Diseases: Guidance for Industry
https://www.fda.gov/media/113807/download
Cellular Therapy for Cardiac Disease: Guidance for Industry
https://www.fda.gov/media/76587/download
Human Gene Therapy for Hemophilia: Guidance for Industry
https://www.fda.gov/media/113799/download
Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products
https://www.ema.europa.eu/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-gene-therapy-medicinal-products_en.pdf
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry
https://www.fda.gov/media/89036/download