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TGA (Australia) - ISCT Responds to Consultation on Priority Review Pathway

ISCT Responds to TGA Consultation on Priority Review pathway for biologicals: feasibility, potential eligibility criteria and determination process

Closed March 28, 2022

ISCT Regulatory Committees (ANZ LRA, EU LRA, NA LRA, SCA LRA, GRTF) and ECGT leadership submitted formal comments in support of this pathway highlighting:
    • Agreement with the four proposed criteria and timeline for Priority Review of biologicals
    • Suggestion for TGA to publish the outcomes of the approved applications for Priority Review determination for transparency
    • Recommendation to clarify certain terms such as ''fast track'', ''significant improvements'' and ''major therapeutic advantage''
View TGA Consultation