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TGC meeting 23, 17 December 2003

Therapeutic Goods Committee

17 December 2003

Meeting report

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TGC 23rd meeting (17 December 2003) report (pdf,56kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 23rd Meeting held on 17 December 2003. 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 22nd meeting of the TGC

The Therapeutic Goods Committee NOTES that:

  • The Minutes of the 22nd Meeting of the Committee were ratified out-of-session on 5 November 2003; and
  • The Summary of Key Resolutions made by the Therapeutic Goods Committee at the 22nd Meeting and the subsequent Information for Stakeholders - Report on Meeting had been placed on the Therapeutic Goods Administration website.

Report on establishment of TGC subcommittees

Subcommittee on blood and tissues

The Therapeutic Goods Committee:

  • NOTES the status of the Subcommittee on Blood and Tissues; and
  • ENDORSES the appointment of the following expert Members:
    • Dr Christopher Juttner;
    • Dr Dominic Wall;
    • Professor Gordon Whyte;
    • Professor Marcus Vowels; and
    • Dr Pauline Warburton.

Subcommittee on child-resistant packaging

The Therapeutic Goods Committee RECOMMENDS the following composition for its expert Subcommittee on Child-Resistant Packaging:

  • A Chairperson who is a Member of the Therapeutic Goods Committee and is appointed by that Committee;
  • A Member with expertise in child-resistant packaging technologies;
  • A Member with expertise in the packaging of pharmaceuticals;
  • A Member with expertise in poisons information services;
  • A Member with expertise in injury prevention and surveillance;
  • A Member with expertise in the regulation of poisons; and
  • A Member with expertise in the consumer use of medicines.

Subcommittee on medicine labelling

In relation to the Therapeutic Goods Committee's Subcommittee on Medicine Labelling, the Therapeutic Goods Committee:

  1. RATIFIES the establishment, in October 2003, of the Subcommittee on Medicine Labelling, with the following Terms of Reference:
    The Subcommittee is to:
    • Consider issues associated with the inclusion of manufacturer details on medicine labels and develop a discussion paper for stakeholder consultation;
    • Guide the consultation process and review stakeholder responses; and
    • Make a recommendation to the Therapeutic Goods Committee on the appropriate amendment of Therapeutic Goods Order No. 69 General standard for labels for medicines and implementation strategy for the new requirement.
  2. ENDORSES the following composition and membership appointments:
    • A Chairperson who is a Member of the Therapeutic Goods Committee and is appointed by that Committee - Professor Stella O'Donnell;
    • Three Members representing the following medicines manufacturing sectors:
      • Prescription medicines - Mr David Clayton;
      • Non-prescription medicines - Dr Mark Bowden;
      • Complementary medicines - Mr Philip Daffy;
    • A Member representing the interests of consumers - Ms Melanie Cantwell, or alternate nominee, for the Consumers' Health Forum of Australia;
    • A Member with expertise in the pharmacy profession - Mr David Newgreen; and
    • A Member with expertise in medicines regulation, drawn from another TGA expert advisory committee - Professor David Story.

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Adoption of British Pharmacopoeia 2003

The Therapeutic Goods Committee RECOMMENDS consideration of the consultation responses on the British Pharmacopoeia 2003 out-of-session, following close of the consultation period on 30 January 2004, with a view to adoption of the British Pharmacopoeia 2003 as the edition of that document defined under the Therapeutic Goods Act 1989.

International non-proprietary names

The Therapeutic Goods Committee:

  • RECOMMENDS that recommended International Non-Proprietary Names (rINNs) be adopted in Australia for substances used in all therapeutic goods, with the exception of adrenaline and noradrenaline; and
  • REQUESTS the Therapeutic Goods Administration to report back to the Committee at its Meeting in March 2004, with a discussion paper on the proposed implementation of rINNs in Australia.

Standard for haematopoietic stem cells

The Therapeutic Goods Committee RECOMMENDS:

  1. The adoption of the 9th edition of the Council of Europe Guide for the preparation, use and quality assurance of blood components as the standard in Australia for blood components including red cells, white cells, platelets and plasma for transfusion;
  2. That the Foundation for the Accreditation of Cellular Therapy (FACT) document Standards for Haematopoietic Progenitor Cell Collection, Processing & Transplantation (2nd edition, March 2002) be adopted as the standard in Australia for haematopoietic progenitor cells harvested from sources other than placental cord blood, with suitable provisions which address areas in the document that may conflict with Australian legislation and guidelines;
  3. That the NETCORD and Foundation for the Accreditation of Haematopoietic Cell Therapy (FAHCT) document International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (2nd edition, July 2001) be adopted as the standard in Australia for haematopoietic progenitor cells harvested from placental cord blood;
  4. That the oversight of haematopoietic progenitor cell provision be based on standards and/or GMP licensure, according to the level of product manipulation and delivery undertaken by a particular facility, and not be circumscribed by considerations of whether usage is to be allogeneic, autologous or directed;
  5. That haematopoietic progenitor cell regulation be specified through a new Therapeutic Goods Order which will:
    • Define the range of products constituting haematopoietic progenitor cells;
    • Delineate the applicable standards for the products;
    • Delineate the regulatory principles applied to the different products; and
    irrespective of the regulatory instrument, the Therapeutic Goods Administration shall ensure compliance through appropriate mechanisms.

Amendment to Therapeutic Goods Order No. 61 Contraceptive devices - rubber condoms

The Therapeutic Goods Committee ENDORSES the draft Therapeutic Goods Order No. 61A - Replacement of TGO 61: Contraceptive Devices - Rubber Condoms.

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