It would seem that the TGA have not updated their regulatory framework for tissues and emerging biological therapies which was discussed in their status report as at 30 April 2004. Give both documents a read!
“Summary of proposed framework for the regulation of cell and tissue therapies”
http://www.tga.gov.au/bt/prtisreg_sum.pdf
The only reference on their website I can find to a code of practice is the current code ( which is to be replaced eventually) :
“Code of Good Manufacturing Practice - Human Blood and Tissues”
dated 24 August 2000
So I rang them
There advice was that the information on the website is correct at the present moment. No, they could not give me the reasons why the application had been postponed or rejected. This advice has been passed to the company concerned and it is a matter for the comapny to explain (or not) why the approval has been rejected or postponed.
Maybe the reason for the TGA delay is because the current Code for GMP doesn't adequately cover the HCT/P's, (Human Cell & tissue and cellulalr and tissue based products) issue. When you look at the proposal it certainly goes into far greater detail than does the current Code. At least as a holder of CCE I hope this is the case. It would be pity that a government agency can hold up the process because a new technology cannot be accomodated under the existing code. I hope this is the reason for the non approval rather than any fault of the comapny (or god forbid) its products to meet requirements. Cheers
CCE Price at posting:
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