Letter to stakeholders who received the first discussion paper on the regulation of human tissues and emerging biological therapies
This is a copy of a letter sent to stakeholders who received the first discussion paper on the regulation of human tissues and emerging biological therapies
RE: National consultations on the regulation of human tissues and emerging biological therapies, April-May 2003
As you are aware, following the recent distribution of a Discussion Paper on the regulation of human tissues and emerging biological therapies <http://www.tga.gov.au/docs/html/humantiss.htm>, the TGA held a series of workshops in Adelaide, Perth, Canberra, Brisbane, Sydney and Melbourne. Approximately 135 people attended the consultations and written submissions were received from 26 individuals and organisations.
The feedback during the consultation process has been very valuable and the issues raised in the discussions will inform the future direction of the proposed regulatory system. We have attached for your consideration a document summarising the main issues that were raised <http://www.tga.gov.au/bt/humantiss_outcomes.htm> during the workshops and in written submissions.
As detailed in the attached document <http://www.tga.gov.au/bt/humantiss_outcomes.htm>, during the workshops we proposed that the TGA write to organisations requesting them to provide the TGA with notification of the various activities they undertake utilising human tissues and cells. This proposal was based on the US model of initial notification and received very strong support during the consultations. We will therefore be shortly sending you another letter together with a form (and accompanying explanatory material) seeking such information. The form and accompanying explanatory material will also be available on the website. We anticipate that this will greatly assist us in developing an appropriate regulatory framework and look forward to your response.
We propose to undertake another round of consultation once a draft framework for the proposed regulatory system has been developed and anticipate that consultations on the draft framework will commence in September 2003. We propose to send the draft framework (and explanatory materials) to all those who received the first Discussion Paper, those who attended workshops and those who respond to the notification process discussed above. The draft framework and supporting explanatory materials will also be placed on the TGA website.
During the recent consultations, stakeholders emphasised the importance of ensuring a sufficient time for stakeholders to consider and comment on documents. To this end, we will ensure that the consultation period runs for at least two months and propose to again hold a series of workshops on the issue in capital cities.
I look forward to your ongoing contributions on this important issue and if you have any queries regarding the process please do not hesitate to contact myself on 6232 8700 or Albert Farrugia (Head, Blood and Tissues Unit) on 6232 8539.
Yours sincerely
Rita Maclachlan
Director
Office of Devices, Blood and Tissues
Therapeutic Goods Administration
24 June 2003