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Therapeutic Goods Committee (TGC)

8 May 2013

Role of the TGC

The Therapeutic Goods Committee (TGC) is established under regulation 34 of the Therapeutic Goods Regulations 1990 (the regulations) to advise and make recommendations to the Minister for Health and Ageing on the adoption of standards for therapeutic goods, matters relating to standards for therapeutic goods, including requirements for labelling and packaging and standards for manufacture of therapeutic goods, and matters relating to medical device standards and conformity assessment standards.

For further details on the role and operation of the TGC, refer to the Therapeutic Goods Regulations 1990.

TGC membership

The TGC has up to 12 members, who are 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.

Chairperson

Professor Klaus Schindhelm is the chair of the Therapeutic Goods Committee, having been a member of the committee since 2002 and the chair of the subcommittee on packaging requirements for therapeutic goods for human use since 2008. He is a senior research executive in an international medical devices corporation. Professor Schindhelm lectures at the Graduate School of Biomedical Engineering of the University of New South Wales and has expertise in biocompatibility. He has an extensive publication record. He is the Chair of the Vision Cooperative Research Centre (Vision CRC) and has previously been a board member of ANSTO. Professor Schindhelm provides expertise in biomedical engineering, and biological safety of biomaterials.

Members

• Associate Professor Chris Alderman is the Director of Pharmacy, Repatriation General Hospital, Adelaide and Associate Professor (Pharmacy Practice), School of Pharmacy and Medical Sciences, University of South Australia, since 2000. He has a doctorate in pharmacy practice. Dr Alderman has extensive experience and expertise in all areas of hospital and community pharmacy practice.
• Mr David Clayton is a senior executive in an international pharmaceutical corporation. He has been responsible for technical support for manufacturing sites of sterile and non-sterile medicines, and management of quality assurance, medical and regulatory affairs. Mr Clayton is a registered pharmacist. Mr Clayton was nominated by a body that represents the interests of Australian manufacturers of prescription medicine products.
• Mr Michael Gepp is the Scientific Affairs Manager of an importer and distributor of active ingredients for medicines. He has experience within the pharmaceutical and complementary medicines industries encompassing manufacturing, quality assurance, product development, regulatory compliance and scientific affairs. Mr Gepp was nominated by a body that represents the interests of Australian manufacturers of complementary medicines.
• Associate Professor Karen Hapgood is a member of the Department of Chemical Engineering, Monash University. Her main professional area is pharmaceutical manufacturing, particularly of solid dosage forms. She undertakes research in granulation and powder technology and teaches undergraduate students. She is a member of the international steering committee of Handbook of Pharmaceutical Excipients. Associate Professor Hapgood provides expertise in pharmaceutical science.
• Dr Robert Kitchen was the director of scientific affairs in an international corporation supplying medical devices and pharmaceutical products. He has experience in product registration and quality assurance. Dr Kitchen was nominated by a body that represents the interests of Australian manufacturers of medical devices and other therapeutic goods.
• Ms Elizabeth Ng is a registered pharmacist and has experience in regulatory affairs in Australia and overseas, with corporations involved in non-prescription medicines, as well as complementary and prescription medicines. She has also worked in hospital and community pharmacy and in government. Ms Ng was nominated by a body that represents the interests of Australian manufacturers of non-prescription medicine products.
• Mr Nichalas Nuttall is the Director of the Queensland Eye Bank and a lecturer at Griffith University in clinical microbiology programs. He is also an academic director of tissue donation and tissue banking programs for Universitat de Barcelona. Mr Nuttall provides expertise in microbiology and virology, and biological safety of bio-materials.
• Dr Lisa Pont is a Senior Lecturer in Pharmacology and Clinical Pharmacy at the Sydney Nursing School, University of Sydney. She is a registered pharmacist, with experience in both hospital and community pharmacy in NSW and Tasmania. Dr Pont provides expertise in hospital and community pharmacy practice.
• Ms Diane Walsh is an experienced consumer representative. She is the Chair and consumer nominee of the General Practice Network Northern Territory and is a member of the National Medicines Policy Committee. Ms Walsh was nominated by a body that represents the interests of consumers of health services.

Subcommittees of the TGC

The TGC currently has two subcommittees:

• Subcommittee on Biologicals
• Subcommittee on Packaging Requirements for Therapeutic Goods for Human Use

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.

TGC meeting dates

TGC meetings 2013

• TBA

Contacting the TGC

To contact the TGC Secretary:

Email	TGC@tga.gov.au
Phone	+61 2 6232 8623
Postal address	The Secretary Therapeutic Goods Committee Therapeutic Goods Administration PO Box 100 Woden ACT 2606 Australia

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