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TGC meeting 31, 29 November 2007

Therapeutic Goods Committee

29 November 2007

Meeting report

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TGC 31st meeting (29 November 2007) meeting report (pdf,127kb)

Summary of key resolutions

Note: This summary has been prepared to provide advice of the Resolutions made by the Therapeutic Goods Committee at its 31st Meeting held on 29 November 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 30th meeting of the TGC

The Therapeutic Goods Committee NOTES that:

  • the Minutes of the 30th Meeting of the Therapeutic Goods Committee held on 3 May 2007 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 2008

The Therapeutic Goods Committee:

  1. NOTES that the British Pharmacopoeia 2008 (BP 2008) has been published and will enter into force in the United Kingdom (UK) on 1 January 2008.
  2. REQUESTS that the Therapeutic Goods Administration undertake consultation with stakeholders on the adoption of BP 2008 as the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989.
  3. RECOMMENDS that this consultation be undertaken as early as possible.
  4. AGREES to give timely consideration to stakeholder responses with a view to making a recommendation regarding adoption of BP 2008 out-of-session.

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Child-resistant packaging - revision of Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods (TGO 65)

The Therapeutic Goods Committee:

  1. NOTES:
    1. the status of the draft Order that was being developed to specify standards for child-resistant packaging (CRP) for application by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA);
    2. development of this draft ANZTPA Order involved thorough review of existing CRP requirements for therapeutic goods in both Australia and New Zealand and was based in large part on Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods (TGO 65); and
    3. that comprehensive stakeholder consultation was undertaken on the draft ANZTPA Order.
  2. RECOMMENDS that:
    1. although establishment of ANZTPA has been postponed, there is strong justification to progress a revision to TGO 65;
    2. the revision should be based on the draft ANZTPA Order and, as far as is consistent with existing therapeutic goods legislation, the resulting new Therapeutic Goods Order (TGO) should include the same technical requirements and be applicable to the same medicines as identified as part of the ANZTPA process;
    3. however the edition of the Australian Standard referred to in the new TGO in relation to reclosable packaging should reflect the most recent edition of that Standard, specifically AS 1928-2007 Child-resistant packaging- Requirements and testing procedures for reclosable packages (ISO 8317:2003, MOD); and
    4. a draft of the new TGO should be released for stakeholder consultation.
  3. AGREES to consider stakeholder responses on the draft TGO, with the aim of finalising the new Order on CRP as early as possible in 2008.

The Therapeutic Goods Committee RECOMMENDS that new Therapeutic Goods Orders no longer incorporate Supplementary Notes but instead be accompanied by a separate guidance document providing a plain English explanation of the Order and its application and which, if appropriate, includes a series of questions and answers.

Development of a best practice guideline for non-reclosable forms of child-resistant packaging

The Therapeutic Goods Committee (TGC):

  1. REINFORCES its recommendation for the development of a best practice guideline on non-reclosable packaging that will assist sponsors improve the effectiveness of blister or foil strip packaging in reducing the potential for accidental childhood poisoning from medicines packaged in this way.
  2. RECOMMENDS that, in light of the importance of this issue, work on the best practice guideline commence as soon as possible;
  3. RECOMMENDS that, to inform the work, the Therapeutic Goods Administration invites stakeholders to submit:
    • Information and/or data indicating the extent to which existing and new formats of blister/strip packaging provide protection for children;
    • Technical information relating to blister and foil strip packaging and formats/enhancements that may provide additional protection for children;
    • Information on how such formats affect the accessibility of the product for elderly adults or those less able;
    • Information on the potential impact for industry of requiring child and adult panel testing of non-reclosable packaging, including comment on the practicalities of the test requirements and the necessary processes and costs of upgrading packaging to achieve compliance;
    • Information on the effectiveness in reducing rates of accidental poisoning of the intervention in the United Kingdom to require non-reclosable packaging used for certain medicines to comply with child and adult panel test requirements of the relevant British Standard;
    • Information on what attributes of packaging or presentation deter children or act to deflect a child's interest; and/or
    • Information on any relationship between the physical characteristics of packaging and its accessibility to children.
  4. RECOMMENDS that information also be sought from relevant overseas regulatory authorities and government agencies (including the UK Medicines and Healthcare Products Regulatory Agency and the US Consumer Product Safety Commission) and Standards organisations.
  5. RECOMMENDS that a specialist subcommittee of the TGC be established to progress this task and provide a report to the TGC at its next Meeting.

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Update to edition of required advisory statements for medicine labels (RASML) referenced in Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)

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) specifies the July 2004 version of the document.
  2. NOTES that the version of RASML currently published on the TGA website is dated April 2006.
  3. NOTES that the Therapeutic Goods Administration undertook appropriate stakeholder consultation on the May 2005 and April 2006 updates to RASML and all updates have been Gazetted.
  4. RECOMMENDS that the definition of 'Required Advisory Statements for Medicines' contained in clause 2 Interpretation of TGO 69 be amended to refer to the April 2006 version of RASML.

Labelling requirements for medicines - revision of Therapeutic Goods Order No. 69 General requirements for labels for medicines (TGO 69)

The Therapeutic Goods Committee:

  1. NOTES:
    1. the status of the draft Order that was being developed to specify general requirements for the labelling of medicines for application by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA);
    2. development of this draft ANZTPA Order involved thorough review by an expert advisory committee of existing requirements for the labelling of medicines in both Australia and New Zealand, and consideration of the needs of the pharmaceutical industry, regulators, health professionals and consumers;
    3. the draft ANZTPA Order was based in large part on Therapeutic Goods Order No. 69 General Requirements for the Labelling of Medicines (TGO 69); and
    4. that comprehensive stakeholder consultation was undertaken twice during the development process.
  2. RECOMMENDS that:
    1. although establishment of ANZTPA has been postponed, there is strong justification to progress a revision to TGO 69;
    2. the revision should be based on the draft ANZTPA Order and, as far as is consistent with existing therapeutic goods legislation, the resulting new Therapeutic Goods Order (TGO) should include the same general requirements as identified as part of the ANZTPA process; and
    3. a draft of the new TGO should be released for stakeholder consultation.
  3. AGREES to consider stakeholder responses on the draft TGO, with the aim of finalising the new Order on medicine labelling as early as possible in 2008.

Standards for tablets and capsules - Revision of Therapeutic Goods Order No. 56 General standard for tablets, pills and capsules (TGO 56)

The Therapeutic Goods Committee (TGC):

  1. NOTES:
    1. the status of the draft Order that was being developed to specify general requirements for tablets and capsules for application by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA); and
    2. development of this draft ANZTPA Order involved thorough review of existing requirements for tablets and capsules in both Australia and New Zealand; consideration of the needs of the pharmaceutical industry, including the complementary medicines sector, and regulators; and developments in pharmacopoeias since the release in 1996 of Therapeutic Goods Order No. 56 General Requirements for Tablets, Pills and Capsules (TGO 56).
  2. RECOMMENDS that:
    1. in keeping with the TGC's Resolutions at its 21st and 26th Meetings, and notwithstanding that establishment of ANZTPA has been postponed, there is strong justification to progress a revision to TGO 56;
    2. the revision should be based on the draft ANZTPA Order and, as far as is consistent with existing therapeutic goods legislation, the resulting new Therapeutic Goods Order (TGO) should include the same technical requirements and be applicable to the equivalent medicines as identified as part of the ANZTPA process; and
    3. a draft of the new TGO should be released for stakeholder consultation.
  3. AGREES to consider stakeholder responses on the draft TGO, with the aim of finalising a new Order on general requirements for tablets and capsules as early as possible in 2008.

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Microbiological standards for medicines

The Therapeutic Goods Committee:

  1. NOTES:
    1. the status of the draft Order that was being developed to specify microbiological standards for medicines for application by the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA); and
    2. development of this draft ANZTPA Order involved thorough review of existing microbiological requirements for medicines in both Australia and New Zealand, and public consultation on the technical requirements proposed for inclusion in the Order.
  2. RECOMMENDS that:
    1. a new Therapeutic Goods Order (TGO) to specify microbiological standards for medicines be established;
    2. the new TGO should be based on the draft ANZTPA Order and, as far as is consistent with existing therapeutic goods legislation, the resulting new TGO should include the same technical requirements and be applicable to the same medicines as identified as part of the ANZTPA process; and
    3. a draft of the new TGO should be released for stakeholder consultation.
  3. AGREES to consider stakeholder responses on the draft TGO, with the aim of finalising the new Order on microbiological standards for medicines as early as possible in 2008.

Proposal to establish a subcommittee to advise on standards for biologicals

The Therapeutic Goods Committee (TGC):

  1. NOTES the requirement for the development of standards to support the proposed the new regulatory scheme for biologicals in particular human cell and tissue products.
  2. RECOMMENDS the establishment of a specialist subcommittee of the TGC to advise on standards for biologicals.
  3. AGREES to the following Terms of Reference for the Subcommittee on Biologicals:
    • To advise the TGC on standards for adoption in relation to the safety and quality of therapeutic goods that are human blood and blood components, blood products, human tissues, progenitor cells, cellular therapies and other products designated as biologicals.
  4. RECOMMENDS that the Subcommittee should be chaired by a member of the TGC and include sufficient members to provide expertise in at least the following fields:
    • infectious diseases and tissue-borne pathogens;
    • banked tissue products;
    • banked blood products;
    • cellular therapies progenitor cells; and
    • tissue engineering.

Review of the Code of Practice for the Tamper-Evident Packaging (TEP) of therapeutic goods

The Therapeutic Goods Committee:

  1. NOTES that the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (TEP Code of Practice) is central to any mandatory requirement for tamper-evident packaging for therapeutic goods.
  2. NOTES that the TEP Code of Practice has not been reviewed since its publication in June 2003.
  3. RECOMMENDS that the TEP Code of Practice be reviewed to ensure it reflects current packaging technologies and stakeholder needs.
  4. RECOMMENDS that this review occur before further action is taken to underpin the TEP Code of Practice legislatively.
  5. RECOMMENDS that this review be undertaken by a subcommittee of the Therapeutic Goods Committee with appropriate expertise.

Transfer of packaging requirements from Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP)

The Therapeutic Goods Committee (TGC):

  1. NOTES:
    1. the status of the draft Australia New Zealand Therapeutic Products (Medicine Standards) Order - Packaging Requirements For Specified Therapeutic Products that was developed by the Joint Interim Expert Advisory Committee On Standards;
    2. that, for Australia, the intent of this draft ANZTPA Order was to action the National Competition Policy Review recommendation for transfer of control of packaging requirements for therapeutic products for human use from the States and Territories to the product regulator; and
    3. the draft Order was based on the container requirements of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).
  2. RECOMMENDS that:
    1. although establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA) has been postponed, there is justification for a Therapeutic Goods Order (TGO) with similar provisions to those of the draft ANZTPA Order for application in Australia only;
    2. as far as is consistent with existing therapeutic goods legislation, the new TGO should be based on the draft ANZTPA Order with further technical review of the proposed requirements being undertaken by a subcommittee of the TGC with appropriate expertise; and
    3. a draft of the new TGO should be released for stakeholder consultation.
  3. AGREES to consider stakeholder responses on the draft TGO, with the aim of finalising the new Order on packaging requirements for specified therapeutic products as early as possible in 2008.

Proposal to establish a subcommittee to advise on packaging matters relating to therapeutic goods

The Therapeutic Goods Committee:

  1. RECOMMENDS that a specialist subcommittee on packaging requirements for therapeutic goods be established to provide advice on matters relating to the packaging of therapeutic goods for human use.
  2. AGREES to the following Terms of Reference for the Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use:
    The Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use is to:
    1. work with the Therapeutic Goods Administration and relevant stakeholder groups to develop a Best Practice Guideline on non-reclosable forms of packaging, such as blister or foil strip packaging, that will assist sponsors to improve the effectiveness of this style of packaging in reducing the potential for children to be accidentally poisoned by medicines packaged in this way;
    2. conduct a review of the document Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods (TEP Code of Practice) to determine whether it reflects current packaging technologies and stakeholder needs, consulting as required with stakeholders, and recommend any amendments considered necessary to update the TEP Code of Practice;
    3. review the relevance of Australian Standard AS 2216-1997, Packaging for Poisonous Substances, to therapeutic goods and develop a draft Therapeutic Goods Order for consultation with stakeholders that will effect the transfer of container requirements for therapeutic goods for human use from the Standard for the Uniform Scheduling of Drugs and Poisons to the Therapeutic Goods Administration, as recommended by the National Competition Policy review of Drugs, Poisons and Controlled Substances Legislation and subsequently accepted by the Australian Health Ministers Advisory Council and Council of Australian Governments; and
    4. report to the Therapeutic Goods Committee on the outcomes of its considerations.
  3. RECOMMENDS that development of the Best Practice Guideline on non-reclosable packaging and review of the TEP Code of Practice should be given priority by the Subcommittee.
  4. RECOMMENDS that the Subcommittee should have the following composition:
    1. a Chairperson who is a member of the Therapeutic Goods Committee;
    2. a sufficient number of members to provide expertise in each of the following fields:
      • packaging materials and components;
      • packaging technologies, including blister and foil strip packaging, tamper-evident packaging and poisons packaging; and
      • packaging of therapeutic goods;
    3. a member with expertise in the consumer use of medicines;
    4. a member with expertise in poisons information and poisoning prevention; and
    5. a State or Territory health department representative.

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