TGC meeting 37, 6 April 2011

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 37th Meeting held on 6 April 2011. It should not be assumed that recommendations made by the TGC to the TGA represent the decisions of the TGA. Reasons underlying the TGC Resolutions will be published separately.

Minutes of the 36th TGC meeting held 11 August 2010

The Therapeutic Goods Committee (TGC) NOTED that:

1. the Resolutions and Minutes of the 36th Meeting of the TGC, held on 11 August 2010, were ratified out-of-session as a true and accurate record of that Meeting
2. the Summary of Key Resolutions was published on the Therapeutic Goods Administration Internet site in February 2011.

Subcommittee reports

The Therapeutic Goods Committee (TGC) NOTED the ratified report from the 3rd Meeting of the Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use.

Overview of the biologicals framework

The Therapeutic Goods Committee (TGC) NOTED:

1. the amendments to the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990 to introduce a regulatory framework for biologicals
2. the range of activities undertaken by the Therapeutic Goods Administration to engage stakeholders.

Overview of the therapeutic goods orders and code of GMP

The Therapeutic Goods Committee (TGC) NOTED:

1. the development of draft Orders to support the biologicals framework
2. the interaction between good manufacturing practices and standards to minimise infectious disease transmission via therapeutic goods
3. the proposed review cycle for the Orders.

Activities of TGC Subcommittee on biologicals

The Therapeutic Goods Committee (TGC) NOTED:

1. the ratified report of the 3rd Meeting of the Subcommittee on Biologicals
2. the ratified report of the 4th Meeting of the Subcommittee on Biologicals
3. the draft report of the 5th Meeting of the Subcommittee on Biologicals.

Infectious diseases order for biologicals

1. The Therapeutic Goods Committee (TGC) NOTED:
   1. stakeholder consultation on the 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 therapy products has been undertaken by the Therapeutic Goods Administration
   2. the TGC Subcommittee on Biologicals has reviewed stakeholder comments and has amended the draft Order
   3. the TGC Subcommittee on Biologicals has endorsed the amended Order and referred it to the TGC.
2. The TGC RECOMMENDED, based on the advice of the Subcommittee on Biologicals which has considered stakeholder comments, that:
   1. Therapeutic Goods Order - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products, following finalisation of any drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act
   2. the transition periods for compliance be as specified in the Order.

Product specific standards for biologicals

1. The Therapeutic Goods Committee (TGC) NOTED:
   1. stakeholder consultation on draft Orders for the standards for human musculoskeletal tissue, human cardiovascular tissue, human ocular tissue and human skin has been undertaken by the Therapeutic Goods Administration
   2. the TGC Subcommittee on Biologicals has reviewed stakeholder comments and has amended the draft Orders
   3. the TGC Subcommittee on Biologicals has endorsed the amended Orders and referred them to the TGC.
2. The TGC RECOMMENDED, based on the advice of the Subcommittee on Biologicals which has considered stakeholder comments, that:
   1. Therapeutic Goods Order - Standard for human musculoskeletal tissue, following finalisation of drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989
   2. Therapeutic Goods Order - Standard for human cardiovascular tissue be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989
   3. Therapeutic Goods Order - Standard for human ocular tissue, following finalisation of drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989
   4. Therapeutic Goods Order - Standard for human skin be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989.

General requirements for the labelling of biologicals

1. The Therapeutic Goods Committee (TGC) NOTED:
   1. the TGC Subcommittee on Biologicals has reviewed stakeholder comments and has amended the draft Order
   2. the TGC Subcommittee on Biologicals has endorsed the amended Order and referred it to the TGC.
2. The TGC RECOMMENDED, based on the advice of the Subcommittee on Biologicals which has considered stakeholder comments, that Therapeutic Goods Order - General requirements for the labelling of biologicals, following finalisation of drafting matters, be adopted as an order made under Section 10 of the Therapeutic Goods Act 1989.

Australian code of good manufacturing practice human blood and blood components, human tissues and human cellular therapy products

1. The Therapeutic Goods Committee (TGC) NOTED:
   1. stakeholder consultation on the draft Australian Code of Good Manufacturing Practice Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products has been undertaken by the Therapeutic Goods Administration
   2. the TGC Subcommittee on Biologicals has reviewed stakeholder comments and minor changes and few editorial changes were made to the draft GMP Code
   3. the TGC Subcommittee on Biologicals has endorsed the amended GMP Code with minor changes and referred it to the TGC.
2. The TGC RECOMMENDED, based on the advice of the Subcommittee on Biologicals which has considered stakeholder comments, that:
   1. the Australian Code of Good Manufacturing Practice Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products, following finalisation of drafting matters, be adopted as the GMP Code and the requirements set out in Part 3-3 of the Therapeutic Goods Act 1989
   2. the transition period for compliance is 12 months and as specified in the Therapeutic Goods Order - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products.

Update on Required advisory statement for medicines label (RASML)

The Therapeutic Goods Committee (TGC) NOTED that the Therapeutic Goods Administration is undertaking stakeholder consultation on a proposed update (Update 6) to the Required Advisory Statements for Medicine Labels (RASML).

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