TGA News Issue 45 (November 2004) - Blood & tissues
Note: The information in this issue of TGA News may no longer be current. Please check with the TGA before relying on the information on these web pages.
Regulatory impact statement
In September 2004, the TGA invited interested parties to view and comment on a Regulatory Impact Statement (RIS) on the proposed framework for Human Cell, Tissues and Cellular and Tissue-based Products. The comment period closed in October 2004.
Technical master files
Now available is the Guideline for the Preparation of Technical Master Files for Blood, Blood Components and Haematopoietic Progenitor Cells <http://www.tga.gov.au/manuf/tmf_blood.htm>. This document assists manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells.