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TGC meeting 30, 3 May 2007

Therapeutic Goods Committee

3 May 2007

Meeting report

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TGC 30th meeting (3 May 2007) report (pdf,76kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 30th Meeting held on 3 May 2007. 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 available in the form of an edited Report following ratification of the Minutes by the Committee.

Minutes of the 29th Meeting of the TGC

The Therapeutic Goods Committee NOTES that:

  • The Minutes of the 29th Meeting of the Therapeutic Goods Committee held on 7 September 2006, were ratified out-of-session as a true and accurate record of that Meeting; and
  • The documents Summary Of Key Resolutions and Information for Stakeholders - Report on Meeting have been published on the TGA website.

Adoption of British Pharmacopoeia 2007

The Therapeutic Goods Committee RECOMMENDS the adoption of the British Pharmacopoeia 2007 on 1 July 2007 for the purposes of the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.

Updating the Australian Code of Good Manufacturing Practice for Medicines

The Therapeutic Goods Committee NOTES the intention of the Therapeutic Goods Administration and Medsafe to consult with the regulated industry in relation to updating the Code of Good Manufacturing Practice for Medicinal Products to reflect current international regulatory practices.

Update on Standards for Cord Blood Banking

The Therapeutic Goods Committee:

  1. NOTES that:
    • The Therapeutic Goods Administration (TGA) has consulted with stakeholders on the adoption of the NETCORD and Foundation for the Accreditation of Cellular Therapy (NETCORD-FACT) document International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release (3rd edition, 2006); and
    • Stakeholders provided overall support for the adoption, although requiring clarification of some technical details.
  2. RECOMMENDS that the TGA, under section 10 of the Therapeutic Goods Act 1989, adopt the NETCORD-FACT standard International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release (3rd edition, 2006) for the regulation of haematopoietic progenitor cells derived from cord blood.
  3. NOTES that the TGA has received advice on the need for a Regulation Impact Statement from the Office of Best Practice Regulation and there is no need for further action in this regard.

Update on Reference in Therapeutic Goods Orders to Withdrawn or Superseded Standards

The Therapeutic Goods Committee NOTES that:

  • Further to the advice provided by the Committee at its 29th Meeting, the Therapeutic Goods Administration has confirmed that there is no legal impediment to testing a therapeutic device against a national or international standard referenced in a Therapeutic Goods Order even though that national or international standard has been replaced by an updated version or withdrawn; and
  • As Therapeutic Goods Order No. 59 Polymer Urethral Catheters for General Medical Use (TGO 59) and Therapeutic Goods Order No. 63 Standard for Sterile Therapeutic Goods (TGO 63) remain relevant to the regulation of polymer urethral catheters for general medical use, and sterile therapeutic devices, respectively, only until the end of the transition period for the new regulatory system for medical devices on 4 October 2007, the Therapeutic Goods Administration does not propose to amend either Order.

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