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Proposed standards and Code of GMP for human blood and blood components, human tissues and human cellular therapies
Consultation
This consultation closed on 12 February 2010
Interested parties were invited to provide comment on the draft Code of GMP, the infectious diseases standard and the four tissue specific standards.
Documents
Written submissions were 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)
- 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)
- Draft Therapeutic Goods Order: Standards for banked human cardiovascular tissue (pdf,152kb)
- Draft Therapeutic Goods Order: Standards for banked human musculoskeletal tissue (pdf,157kb)
- Draft Therapeutic Goods Order: Standards for banked human ocular tissue (pdf,96kb)
- Draft Therapeutic Goods Order: Standards for banked human skin (pdf,143kb)
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.
A Guide to the Consultation Process has been written and supplied for the current consultation and includes further background information and context.
Enquiries
Enquiries should be directed via email to bloodandtissues@tga.gov.au or by telephone to 02 6232 8443.
Public submissions
22 October 2010
All submissions received during the consultation period are published below, unless they were marked as confidential.
The comments received have been reviewed by the TGA and were presented to the Therapeutic Goods Committees' (TGC) Subcommittee on Biologicals at the meeting of 22 July 2010, for their consideration.
On reviewing stakeholder comments on the five Orders it became clear that there were a number of common areas of concern highlighted by stakeholders, these were:
- Donor selection issues including:
- Timing and requirements for the examination and consent of living donors
- Disease and age exclusion criteria for living donors
- Timing and requirements for sampling and testing of donors
- Assessment of microbial contamination and minimisation of bioburden
- Requirements for transport, storage, quarantine and banking
- Standards for plasma for fractionation products.
Consideration of these matters has resulted in significant revisions to all five Orders. The TGC Subcommittee on Biologicals has therefore recommended that the revised Orders be released for a second round of stakeholder consultation. This consultation is expected to commence in November 2010.
Submissions on the Code of GMP have resulted in minor changes to this document. Therefore a second round of consultation on the Code of GMP is not warranted.
Submissions on the Code of GMP
- Public submission: Anonymous 1 (pdf,15kb)
- Public submission: Anonymous 2 (pdf,11kb)
- Public submission: Anonymous 3 (pdf,13kb)
- Public submission: Anonymous 4 (pdf,15kb)
- Public submission: Australian Biotechnologies (pdf,32kb)
- Public submission: Australian Institute of Medical Scientists (pdf,34kb)
- Australian Red Cross Blood Service (Name only, No attachments)
- Public submission: Australasian Tissue Banking Forum (pdf,69kb)
- Public submission: Barwon Health Bone Bank (pdf,71kb)
- Public submission: The Childrens Hospital at Westmead (pdf,114kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,18kb)
- Public submission: ERA Consulting (pdf,42kb)
- Public submission: Eye Bank Association of Australia and New Zealand and Australia and New Zealand Corneal Society (pdf,144kb)
- Public submission: Hunter New England Bone Bank (pdf,18kb)
- Public submission: Medical Technology Association of Australia (pdf,36kb)
- Public submission: New Zealand Blood Service (pdf,27kb)
- Public submission: New Zealand Heart Valve Bank (pdf,11kb)
- Public submission: Perth Bone and Tissue Bank (pdf,37kb)
- Public submission: Peter MacCallum Cancer Centre, Centre for Blood Cell Therapies (pdf,34kb)
- Public submission: Peter Madden (pdf,157kb)
- Public submission: Royal Perth Hospital Cell and Tissue Therapies WA (pdf,129kb)
- Public submission: Westmead Hospital Islet Transplant Program and Australian Islet Transplant Consortium (pdf,73kb)
- Public submission: Westmead Research Hub, Centre for Cell and Gene Therapy Steering Committee (pdf,34kb)
Submissions on the infectious diseases standard
- Public submission: Anonymous 1 (pdf,24kb)
- Public submission: Anonymous 2 (pdf,13kb)
- Public submission: Anonymous 3 (pdf,10kb)
- Public submission: Anonymous 4 (pdf,45kb)
- Public submission: American Association of Tissue Banks (pdf,319kb)
- Public submission: Australian Bone Marrow Donor Registry, AusCord (pdf,76kb)
- Public submission: Australian Biotechnologies (pdf,32kb)
- Public submission: Australian Institute of Medical Scientists (pdf,24kb)
- Public submission: Australian Orthopaedic Association (pdf,28kb)
- Australian Red Cross Blood Service (Name only, No attachments)
- Public submission: Australasian Tissue Banking Forum (pdf,156kb)
- Public submission: Barwon Health Bone Bank (pdf,65kb)
- Public submission: The Childrens Hospital at Westmead (pdf,112kb)
- Public submission: Cryosite (pdf,11kb)
- Public submission: CSL Biotherapies (pdf,89kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,22kb)
- Public submission: ERA Consulting (pdf,32kb)
- Public submission: Eye Bank Association of America (pdf,123kb)
- Public submission: Eye Bank Association of Australia and New Zealand and Australia and New Zealand Corneal Society (pdf,203kb)
- Public submission: Hunter New England Bone Bank (pdf,18kb)
- Public submission: IVD Australia (pdf,112kb)
- Public submission: New Zealand Blood Service 1 (pdf,25kb)
- Public submission: New Zealand Blood Service 2 (pdf,26kb)
- Public submission: New Zealand Heart Valve Bank (pdf,25kb)
- Public submission: Octapharma (pdf,85kb)
- Public submission: Perth Bone and Tissue Bank (pdf,29kb)
- Public submission: Peter MacCallum Cancer Centre, Centre for Blood Cell Therapies (pdf,22kb)
- Public submission: Peter Madden (pdf,128kb)
- Public submission: Plasma Protein Therapeutics Association (pdf,36kb)
- Public submission: Royal Australian College of Surgeons, Prevention of Hospital Acquired Infection Committee (pdf,41kb)
- Public submission: Royal Australian College of Surgeons (pdf,51kb)
- Public submission: Royal College of Pathologists of Australasia (pdf,35kb)
- Public submission: Royal Perth Hospital Cell and Tissue Therapies WA (pdf,41kb)
- Public submission: Westmead Research Hub, Centre for Cell and Gene Therapy Steering Committee (pdf,28kb)
Submissions on the musculoskeletal standard
- Public submission: Anonymous 1 (pdf,16kb)
- Public submission: American Association of Tissue Banks (pdf,187kb)
- Public submission: Australian Biotechnologies (pdf,21kb)
- Public submission: Australasian Tissue Banking Forum (pdf,38kb)
- Public submission: Barwon Health Bone Bank (pdf,71kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,20kb)
- Public submission: Hunter New England Bone Bank (pdf,15kb)
- Public submission: New Zealand Blood Service (pdf,17kb)
- Public submission: Perth Bone and Tissue Bank (pdf,15kb)
- Public submission: Queensland Bone Bank (pdf,90kb)
Submissions on the cardiovascular standard
- Public submission: Australasian Tissue Banking Forum (pdf,88kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,19kb)
- Public submission: New Zealand Heart Valve Bank (pdf,14kb)
- Public submission: Royal Perth Hospital Cell and Tissue Therapies WA (pdf,39kb)
Submissions on the ocular standard
- Public submission: Anonymous 3 (pdf,10kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,12kb)
- Public submission: Eye Bank Association of America (pdf,121kb)
- Public submission: Eye Bank Association of Australia and New Zealand and Australia and New Zealand Corneal Society (pdf,196kb)
- Public submission: Peter Madden (pdf,65kb)
Submissions on the skin standard
- Public submission: Australasian Tissue Banking Forum (pdf,76kb)
- Public submission: Donor Tissue Bank of Victoria (pdf,17kb)
- Public submission: New Zealand Blood Service (pdf,15kb)
Combined submissions on the infectious diseases standard and Code of GMP
- Public submission: Australian and New Zealand Childrens Haematology and Oncology Group (pdf,102kb)
- Public submission: Australian Bone Marrow Donor Registry (pdf,152kb)
- Public submission: Blood and Marrow Transplant Network NSW 1 (pdf,61kb)
- Public submission: Blood and Marrow Transplant Network NSW 2 (pdf,174kb)
- Public submission: Royal Brisbane and Women's Hospital and Royal Children's Hospital, Bone and Marrow Transplant Program (pdf,442kb)