Proposed standards and Code of GMP for human blood and blood components, human tissues and human cellular therapies
7 December 2009
This consultation closed on 12 February 2010
Documents
Written submissions are invited on the following documents:
- Draft Australian Code of Good Manufacturing Practice human blood and blood components, human tissues and human cellular therapies (pdf,202kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-cgmp.pdf> - Draft Therapeutic Goods Order: Standards for minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapies (pdf,276kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-tgoinfectious.pdf> - Draft Therapeutic Goods Order: Standards for banked human cardiovascular tissue (pdf,152kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-tgobct.pdf> - Draft Therapeutic Goods Order: Standards for banked human musculoskeletal tissue (pdf,157kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-tgobmt.pdf> - Draft Therapeutic Goods Order: Standards for banked human ocular tissue (pdf,96kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-tgobot.pdf> - Draft Therapeutic Goods Order: Standards for banked human skin (pdf,143kb)
<http://www.tga.gov.au/bt/consult/drbloodstandards-tgobhs.pdf>
In addition, the following accompanying resource document is also available:
Background
In July 2002 the Australian Health Ministers' Conference recommended that the Therapeutic Goods Administration (TGA) develop a new regulatory framework for human cell and tissue therapies and other emerging biological therapies. A framework to regulate these products was proposed by the TGA during the development of the now postponed joint Australia New Zealand Therapeutic Products Agency (ANZTPA). During this time significant consultation was undertaken on the development of standards. Following the postponement of ANZTPA in 2007, the Government agreed in 2008 to move forward with a number of improvements identified during the development of ANZTPA in an Australia-only context.
The TGA is inviting stakeholders to comment on five newly drafted Therapeutic Goods Orders (TGOs) and an amended Code of GMP for blood and blood components, human tissues and human cellular therapies. The five new TGOs are proposed to mandate a standard for minimising the risk of transmission of infectious diseases and four tissue-specific standards for banked cardiovascular tissue, musculoskeletal tissue, ocular tissue and skin. The new TGOs clarify best practice requirements, increase the degree of international harmonisation and ensure ongoing flexibility to respond to new technologies. The draft Code of GMP is an amended version of the current Code of GMP for human blood and tissues (2000) which has applied to manufacturers and has been in place for almost 10 years.
The draft Code of GMP and the infectious diseases standard are intended to apply to all human blood and blood components, human tissues and human cellular therapy products. Some of these products will be regulated under a new regulatory framework for Biologicals. Products regulated under the new Biologicals framework will also have to comply with the relevant tissue specific standards i.e. standards for banked cardiovascular, musculoskeletal and ocular tissue and skin. For more information on the Biologicals framework please see Biologicals framework implementation <http://www.tga.gov.au/bt/hct.htm>.
A Guide to the Consultation Process has been written and supplied for the current consultation and includes further background information and context.
Invitation to comment
Interested parties were invited to provide comment on the draft Code of GMP, the infectious diseases standard and the four tissue specific standards.
The TGA will be reviewing comments received as they relate to each consultation document. It would be helpful if you could please provide comments for each consultation document as separate documents and clearly indicate the specific standards/Code of GMP and section to which each comment relates. Where possible, relevant data and/or examples to support the views expressed should be provided.
Enquiries
Enquiries should be directed via email to biologicals_consultation@tga.gov.au or by telephone to 02 6232 8443.
What will happen to the submissions?
Submissions will be reviewed by the TGA and provided to the Therapeutic Goods Committee (TGC) for consideration. Recommendations made by the TGC following consideration of submissions from interested parties will be published on the TGA website as committee outcomes.
Notes on submissions
All submissions received will be placed on the TGA's website, unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.
For submissions made by individuals, all personal details, other than your name, will be removed from your submission before it is published on the TGA's website.
In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.