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TGA (Australia) - ISCT Supports Adoption of certain international scientific guidelines in Australia

  
ISCT Supports Therapeutic Goods Administration (TGA) Adoption of certain international scientific guidelines in Australia



Closed February 20, 2022

ISCT Regulatory Committees (ANZ LRA, EU LRA, NA LRA, SCA LRA, GRTF) submitted formal comments in support of the adoption of 3 ATMP/CGT Guidances:

  • Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (EMA/CAT/80183/2014) 
  • Guideline on safety and efficacy follow-up - Risk management of advanced therapy medicinal products (EMEA/149995/2008) 
  • ICH Considerations. General principles to address virus and vector shedding (EMEA/CHMP/ICH/449035/2009) 

View TGA Consultation 

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