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TGC meeting 33, 15-16 October 2008

Therapeutic Goods Committee

15 October 2008

Meeting report

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TGC 33rd meeting (15-16 October 2008) meeting report (pdf,163kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 33rd Meeting held on 15-16 October 2008. 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.

Ratification processes and minutes of the 32nd meeting of the Therapeutic Goods Committee

The Therapeutic Goods Committee (TGC):

  1. AGREES that the processes developed by the TGC at its 19th Meeting, held in November 2001, for the ratification of Minutes out of session and the public release of key outcomes and a report on each meeting, should be continued.
  2. NOTES that:
    1. the Minutes of the 32nd Meeting of the TGC held on 29 April 2008 were ratified out-of-session as a true and accurate record of that Meeting; and
    2. the documents Summary of Key Resolutions and Information for Stakeholders - Report on Meeting have been published on the TGA internet site.

Subcommittee reports - Subcommittee on Biologicals

The Therapeutic Goods Committee:

  1. NOTES that appointment of members to the Subcommittee on Biologicals was finalised in May 2008.
  2. NOTES that the first meeting of the Subcommittee was held on 23 July 2008.
  3. ACCEPTS the report of the first meeting of the Subcommittee, noting that further work is to be undertaken.

Subcommittee reports - Subcommittee on Packing Requirements for Therapeutic Goods

The Therapeutic Goods Committee NOTES that the first meeting of the Subcommittee has been scheduled for November 2008.

Development of a Therapeutic Goods Order for all therapeutic goods containing heparin

The Therapeutic Goods Committee:

  1. NOTES that the Therapeutic Goods Administration is developing a Therapeutic Goods Order that references the United States Pharmacopeia test for "over-sulphated chondroitin sulphate" as the standard for all therapeutic goods that contain heparin.
  2. NOTES that it is proposed that the Therapeutic Goods Order have a 2 year sunset clause by which time it is expected that other mechanisms of control will be in place for these goods.

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Status report on adoption of multiple Pharmacopoeias as default standards

The Therapeutic Goods Committee NOTES that changes to the Therapeutic Goods Act 1989 to adopt the British Pharmacopoeia, the European Pharmacopoeia and United States Pharmacopeia-National Formulary as equal default standards for medicines and other therapeutic goods that are not medical devices are being prepared for consideration by the Australian Parliament.

Implications of multiple default Pharmacopoeias - resolution of inconsistencies and/or conflicts

The Therapeutic Goods Committee:

  1. NOTES:
    1. that changes to the Therapeutic Goods Act 1989 (the Act) to adopt the British Pharmacopoeia, the European Pharmacopoeia and United States Pharmacopeia-National Formulary (USP-NF) as equal default standards for medicines and other therapeutic goods that are not medical devices will inevitably lead to the situation of individual monographs for the same therapeutic good specifying different and sometimes inconsistent requirements; and
    2. that in a small number of cases such differences could have clinical consequences or create regulatory problems.
  2. NOTES that the Therapeutic Goods Administration has identified the following situations as being of concern:
    1. where monographs of the USP-NF for biological products are not 'stand alone' but reference or rely upon United States (US) legislation and decisions of the US Food and Drug Administration (FDA);
    2. where monographs of the USP-NF for blood products are not 'stand alone' but reference or rely upon US legislation and decisions of the US FDA;
    3. where USP Units used in assays and potency testing conducted in accordance with the USP-NF are not interchangeable with International Units or metric units, with potential for product labelling in USP Units to be confusing to users; and
    4. where monographs of the USP-NF for water for injection permit production of water by methods other than distillation, leading to concerns about microbiological quality.
  3. PROPOSES that a new Therapeutic Goods Order be developed to specify that biological products should comply with the British Pharmacopoeia or the European Pharmacopoeia, and not the USP-NF, in cases where the USP-NF references other US documents and requirements.
  4. PROPOSES that a new Therapeutic Goods Order be developed to specify that blood products should comply with the British Pharmacopoeia or the European Pharmacopoeia, and not the USP-NF, in cases where the USP-NF references other US documents and requirements.
  5. PROPOSES that amendment to Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines be made to require the expression on labels of quantities to be in metric or International Units, and to disallow labelling in USP Units.
  6. PROPOSES that a new Therapeutic Goods Order be developed to specify that water for injection should comply with the British Pharmacopoeia or the European Pharmacopoeia, and not the USP-NF.
  7. RECOMMENDS that these new or amended Therapeutic Goods Orders should be released for stakeholder consultation.
  8. AGREES to consider stakeholder responses on the draft Therapeutic Goods Orders with the aim of finalising the new Orders, if agreed, to suit the timetable for the introduction in the Act of the European Pharmacopoeia and the USP-NF as equal default standards to the British Pharmacopoeia.

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British Pharmacopoeia 2009

The Therapeutic Goods Committee (TGC):

  1. NOTES that the British Pharmacopoeia 2009 (BP 2009) has been published and will enter into force in the United Kingdom (UK) on 1 January 2009.
  2. NOTES that notwithstanding the planned recognition of multiple pharmacopoeias 'as amended from time to time' as equal standards under the Therapeutic Goods Act 1989 (the Act), the timing for this legislative change is at the discretion of the Parliament.
  3. CONSIDERS that it would be prudent to consult with stakeholders on the adoption of BP 2009 as the default standard under existing therapeutic goods legislation as an interim measure to avoid a superseded edition of the British Pharmacopoeia remaining the default standard for an extended time.
  4. REQUESTS that the Therapeutic Goods Administration undertake this stakeholder consultation on behalf of the TGC.
  5. AGREES to consider the outcomes of the consultation at its next Meeting, at which time the need for amendment to the edition of the British Pharmacopoeia currently specified in the Act should be clearer.

Standards for anthroposophic and homoeopathic medicines

The Therapeutic Goods Committee (TGC):

  1. NOTES the Therapeutic Goods Administration's consultation paper Regulation of Homoeopathic and Anthroposophic Medicines in Australia which was released for stakeholder comment in August 2008.
  2. NOTES the proposal contained in the consultation document that the Therapeutic Goods Act 1989 (the Act) be amended to include a range of alternative default standards for homoeopathic medicines and anthroposophic medicines.
  3. ENDORSES, in principle, that the Act should allow for appropriate and specific default standards for homoeopathic and anthroposophic medicines.

Medicine labelling - stakeholder consultation on draft Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines

The Therapeutic Goods Committee:

  1. NOTES:
    1. the draft Therapeutic Goods Order on medicine labelling [Therapeutic Goods Order No. 79 General Requirements for the Labelling of Medicines (TGO 79) (draft)] which underwent stakeholder consultation in January-February 2008; and
    2. the large number of stakeholder responses to TGO 79 (draft), which were varied and raised significant matters for consideration.
  2. IDENTIFIES the matters listed below for further review:
    1. batch and expiry dating of individual plastic ampoules that are joined to a connecting strip;
    2. expansion of the First Schedule to include additional excipients that must be declared on labels;
    3. expression of quantity or proportion of active ingredient in transdermal patches;
    4. expression of quantity or proportion where an active ingredient is a herbal extract;
    5. inclusion of the route of administration on all injections and on any other medicine contained in an ampoule, whether or not for injection;
    6. legibility requirements including issues of colour contrast and embossing/debossing;
    7. prominence of active ingredient names (font size and position);
    8. requirements and concessions for small and very small containers and equivalent sized injections (required information and definitions);
    9. requirements and concessions for strip, blister and dial dispenser packs and individually wrapped goods;
    10. requirements for homoeopathic and anthroposophic medicines to apply under the proposed new framework for the regulation of homoeopathic and anthroposophic medicines in Australia;
    11. space allowance on prescription medicines for placement of a dispensing label; and
    12. statement of volume on injections and expression of strength on liquids for oral administration and injections.
  3. RECOMMENDS that, rather than implementing TGO 79 at this time, the initiatives identified above should be progressed as possible amendments to Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines (TGO 69).
  4. NOTES that independently to the consultation on TGO 79 (draft), the following additional matters relating to medicine labelling have been identified as warranting consideration for inclusion in TGO 69 as mandatory requirements:
    1. bar coding of medicines or particular types of medicines; and
    2. inclusion of identifying information on transdermal patches.

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Medicines labelling - update to edition of Required Advisory Statements for Medicine Labels (RASML) referenced in Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines

  1. The Therapeutic Goods Committee:
    1. NOTES that the definition of Required Advisory Statements for Medicine Labels (RASML) contained in Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines (TGO 69) refers to the version of RASML dated April 2006;
    2. NOTES that the current version of RASML, as published on the Therapeutic Goods Administration (TGA) internet site, is dated September 2008;
    3. NOTES that the April 2008 and September 2008 updates to RASML followed stakeholder consultation undertaken by the TGA, and all updates have been gazetted; and
    4. RECOMMENDS that the definition of Required Advisory Statements for Medicine Labels contained in clause 2, Interpretation, of TGO 69 should be amended to refer to the September 2008 version of that document.
  2. The Therapeutic Goods Committee:
    1. NOTES that warning statements for medicines containing Vitamin A that are included in the current version of RASML express Vitamin A content in retinol equivalents;
    2. RECOMMENDS that a consequential amendment be made to TGO 69 to require the statement of quantity or proportion of Vitamin A contained in medicines also to be expressed in retinol equivalents; and
    3. REQUESTS that the TGA ensure that administrative processes are in place to resolve anomalies between the expression of Vitamin A content on the label of medicines and any required Vitamin A warning statements until such time as the recommended amendments to TGO 69 become effective.

Medicine labelling - labelling of transdermal patches

The Therapeutic Goods Committee (TGC):

  1. NOTES the recommendation made by the Medicines Evaluation Committee that all transdermal patches should be labelled with sufficient information to allow identification of the patch, including the active ingredient and the strength, after application to a patient.
  2. RECOMMENDS that:
    1. the labelling of transdermal patches and the need for inclusion of identifying information on the patch itself be considered as part of the TGC's further review of Therapeutic Goods Order No. 69 General Requirements for Labels for Medicines; and
    2. to inform that consideration, comment be sought from the relevant product regulators on the presentation of existing transdermal patches and the potential for inclusion of identifying information when not already shown.

Medicine labelling - inclusion of bar codes on medicine labels

The Therapeutic Goods Committee:

  1. NOTES that the inclusion of bar codes on medicines has potential to improve patient safety through reducing dispensing errors.
  2. NOTES the increasing use of bar code scanners in pharmacies as a routine part of the dispensing process.
  3. AGREES that consideration of mandatory bar coding requirements for medicines should be given high priority.
  4. REQUESTS that the Therapeutic Goods Administration gather further information on bar code technologies and formats, current industry practice in Australia and overseas, and international regulatory practice, for consideration by the Therapeutic Goods Committee.

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Standards for export only medicine

  1. The Therapeutic Goods Committee RECOMMENDS that Therapeutic Goods Order No. 70B Standards for Export Only Medicine be amended to update the references to all pharmacopoeias included in it, as follows:
    1. British Pharmacopoeia 2005 be amended to British Pharmacopoeia, with the edition to be that defined under the Therapeutic Goods Act 1989;
    2. European Pharmacopoeia 5th edition be amended to European Pharmacopoeia 6th edition;
    3. United States Pharmacopeia 29th edition-National Formulary 24th edition be amended to United States Pharmacopeia 31st edition-National Formulary 26th edition; and
    4. Japanese Pharmacopoeia 14th edition be amended to Japanese Pharmacopoeia 15th edition.
  2. The Therapeutic Goods Committee:
    1. NOTES that the Therapeutic Goods Administration will be undertaking stakeholder consultation on proposed new arrangements for the export of medicines from Australia;
    2. NOTES that further consideration of standards for export only medicine may be necessary as part of the proposed new arrangements; and
    3. REQUESTS that the Committee be kept informed of progress in the development of the new arrangements for the export of medicines from Australia.

Standards for blood, blood components and plasma for fractionation

The Therapeutic Goods Committee RECOMMENDS:

  1. the adoption of the 14th edition of the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe document Guide for the Preparation, Use and Quality Assurance of Blood Components, dated 2008, Council of Europe Publishing, (the Guide) as the standard in Australia for blood, blood components and plasma for fractionation including red cells, white cells, platelets and plasma for transfusion.
  2. that reference to tropical areas under the heading "tropical diseases" on page 65 of the Guide should not be taken to include areas within Australia.
  3. that individuals with a malignant disease, or history of such, should not be permanently deferred from donation as specified on page 63 of the Guide.
  4. that, as currently specified in Therapeutic Goods Order No. 74 Standards for Blood Components:
    1. blood, blood components and plasma for fractionation must only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology; and
    2. blood, blood components and plasma for fractionation must not be manufactured from blood donors who:
      • have lived in the United Kingdom for a cumulative period of six months or more between 1 January 1980 and 31 December 1996; or
      • have had a transfusion of blood or blood products in the United Kingdom from 1980 onwards.

Update on development of a standard for the minimisation of infectious disease transmission via human tissue based products

The Therapeutic Goods Committee (TGC):

  1. NOTES progress by the TGC's Subcommittee on Biologicals, and the Therapeutic Goods Administration (TGA), in preparing a draft standard for the minimisation of infectious disease transmission via human tissue based products.
  2. NOTES that the draft standard draws on work previously undertaken by the TGA in conjunction with various working groups convened from the tissue banking sector.
  3. NOTES that broad stakeholder consultation will need to be undertaken on the draft standard to ensure that all tissue banks are afforded the opportunity to provide comment.
  4. RECOMMENDS that this consultation be undertaken at the direction of the Subcommittee, with stakeholder responses to be reviewed by the Subcommittee prior to consideration by the TGC.

Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual - proposed amendment to adopt the new standard AS/NZS 2869:2008 Tampons Menstrual

The Therapeutic Goods Committee:

  1. NOTES that Standards Australia has developed a new tampons standard, AS/NZS 2869:2008 Tampons Menstrual which:
    1. adopts a new absorbency test methodology, namely the EDANA/FDA methodology; and
    2. updates the reference to the Toxic Shock Syndrome Information Service (TSSIS).
  2. NOTES that the Therapeutic Goods Administration is currently consulting key industry bodies on the proposal to amend Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual, as amended by Therapeutic Goods Order No. 64A, to adopt the new Australia New Zealand Standard AS/NZS 2869:2008 Tampons - Menstrual.
  3. RECOMMENDS that, subject to industry agreement, Therapeutic Goods Order No. 64 Standard for Tampons - Menstrual is amended to adopt AS/NZS 2869:2008 Tampons - Menstrual.

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