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Australia TGA: Blood rule "should not impede" new technology

This article was originally published in Clinica

Executive Summary

Australia has issued a guideline for the preparation of technical master files (TMFs) for blood, blood components and haematopoietic progenitor cells. It is aimed at assisting manufacturers by describing the scope, detail and depth of information required in TMFs to demonstrate the safety of blood products and haematopoietic progenitor cells, which are precursors of blood cells found in umbilical cord blood and bone marrow.





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