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Proposed standards and Code of GMP for human blood and blood components, human tissues and human cellular therapies

Consultation

7 December 2009

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

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Written submissions were invited on the following documents:

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

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Submissions on the infectious diseases standard

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Submissions on the musculoskeletal standard

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Submissions on the cardiovascular standard

Submissions on the ocular standard

Submissions on the skin standard

Combined submissions on the infectious diseases standard and Code of GMP

Combined submission on the infectious diseases standard and Code of GMP and musculoskeletal