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Therapeutic Goods Committee (TGC)

The Therapeutic Goods Committee (TGC) is established under regulation 34 of the Therapeutic Goods Regulations 1990 (the regulations) to advise the Minister for Health and Ageing on the adoption of standards for therapeutic goods for human use, and matters relating to standards, including labelling and packaging, and the principles to be observed in the manufacture of therapeutic goods for human use.

For further details on the role and operation of the TGC, refer to the Therapeutic Goods Regulations 1990 <http://www.tga.gov.au/legis/index.htm>.

Membership

The TGC has 10 members, who have been appointed by the Minister for Health and Ageing. The membership includes experts in various fields relevant to therapeutic goods regulation, and nominees of organisations which represent the interests of the main sectors of the therapeutic goods industry, as well as consumers of health services. Nominees of organisations are appointed on the basis of their individual skills, knowledge and expertise and are not considered to be representatives of the nominating organisations.

Member Capacity in which appointed
Chairperson
Associate Professor Loraine Holley A person with expertise in biomedical engineering
Members
Mr David Clayton Nominee of a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of prescription medicine products
Ms Anthea Steans Nominee of a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of non-prescription medicine products
Mr Michael Gepp Nominee of a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of complementary medicines
Mr Alan Leslie Nominee of a body that represents, or a combination of bodies that together represent, the interests of Australian manufacturers of medical devices and other therapeutic goods
Ms Diane Walsh Nominee of a body that represents, or a combination of bodies that together represent, the interests of consumers of health services.
Dr Geoffrey Higgins A person with expertise in microbiology and virology
Professor Klaus Schindhelm A person with expertise in the biological safety of biomaterials
Dr Meera Verma A person with expertise in biotechnology
Dr Karen Hapgood A person with expertise in pharmaceutical sciences

Subcommittees of the TGC

The regulations permit the TGC to appoint subcommittees, consisting of members of the TGC and other persons, to inquire into, and report to the TGC on, any matter that is within the functions of the committee.

The TGC currently has two subcommittees:

Subcommittee on Biologicals

This Subcommittee was established 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.

Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use

This Subcommittee was established to:

  • work with the TGA 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;
  • conduct a review of the 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; and
  • 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 TGA.

Secretariat

The Secretariat for the TGC is located within the Office of Laboratories and Scientific Services of the Therapeutic Goods Administration (TGA).

All correspondence to the committee should be addressed to the committee secretary, as follows:

Ms Lyn Lewis
Secretary, Therapeutic Goods Committee
PO Box 100
WODEN ACT 2606

Alternate contact details are:

Telephone: 02 6232 8661
Fax: 02 6232 8442
Email:

TGC stakeholder consultations

Current consultations

Closed consultations

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