The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health. The TGA's Branches are arranged into three major Divisions - Market Authorisation Division, Monitoring and Compliance Division and Regulatory Support Division. The National Manager of TGA is a member of the Department of Health’s Executive Committee and is supported by a Principal Medical Adviser and a Principal Legal Adviser.
The TGA Executive has overall responsibility for the management of the TGA's regulatory functions and activities.
The TGA Executive comprises:
- TGA National Manager, Adjunct Prof John Skerritt
- Principal Medical Adviser, Dr Tony Hobbs
- Principal Legal Adviser, Ms Philippa Horner
- First Assistant Secretary, Market Authorisation Division, Dr Lisa Studdert
- First Assistant Secretary, Monitoring and Compliance Division, Dr Larry Kelly
- First Assistant Secretary, Regulatory Support Division, Ms Samantha Palmer
Market Authorisation Division
The Market Authorisation Division is responsible for undertaking evaluations of applications to approve new therapeutic products for supply in Australia. Senior managers in the Division make decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia.
The Branches in the Division are:
Medicines Authorisation Branch
Branch Head: Dr Peter Bird
Complementary Medicines Branch
Branch Head: Ms Trisha Garrett
- Responsible for approving complementary medicines, including traditional and herbal medicines and vitamin and mineral supplements.
Devices Authorisation Branch
Branch Head: Dr Cheryl McRae
- Responsible for approving medical devices, including in vitro diagnostic medical devices (IVDs).
Scientific Evaluation and Special Product Access Branch
Branch Head: Mr Bill Turner
- Provides scientific advice to support the decisions made by the Market Authorisation Division, in particular non-clinical aspects.
- This includes toxicological and pharmaceutical chemistry evaluation of therapeutic products and expertise in biological sciences.
- The Drug Control Unit is responsible for granting permits and licenses that authorise the import and export of certain narcotic drugs, psychotropic substances, precursor chemicals, antibiotics and androgenic/anabolic substances.
- The Experimental Products Unit which is responsible for the evaluation and authorisation of certain clinical trials and special access arrangements for all types of therapeutic products.
- The Branch is also responsible for approving application to market biological in Australia.
Monitoring and Compliance Division
The Monitoring and Compliance Division is responsible for ongoing monitoring of therapeutic products approved for supply in Australia to ensure they meet the necessary standards throughout their lifecycle.
The way our medicines, devices and biologicals are manufactured is also regulated by the TGA. Australian and international manufacturers must operate in a manner that results in products meeting specified standards if they are to be supplied in Australia. The TGA conducts regular inspections of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards.
The Branches and Unit in the Division are:
Post-Market Surveillance Branch
Branch Head: Dr Jane Cook
- Responsible for overseeing all therapeutic products to ensure they continue to maintain an appropriate level of quality, safety, efficacy and performance following entry into the Australian marketplace.
- Monitoring reports of adverse events and reviewing medicine ingredients and device components.
- The Advertising and Recalls Unit also sits within this Branch and is responsible for ensuring that the advertising of therapeutic goods in Australia meets legislative requirements and coordinating product recalls when necessary.
Branch Head: Dr Mark McDonald
- Responsible for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines such as, microbiology, immunobiology, molecular biology, biochemistry, chemistry, and biomaterials and engineering.
Manufacturing Quality Branch
Branch Head: Dr Harry Rothenfluh
- Responsible for ensuring manufacturers of medicines and medical devices meet appropriate standards of quality.
Regulatory Compliance Unit
Section Head: Mr Eric McIntosh
- The Regulatory Compliance Unit is responsible for on-going surveillance, enforcement and related activities, including investigations into illegal and counterfeit therapeutic goods.
Regulatory Support Division
The Regulatory Support Division provides whole-of-agency regulatory support services that enable the TGA to undertake its regulatory responsibilities. This includes the legal, finance, information technology and information management, parliamentary, planning and education and human resource management services.
The Branches in the Division are:
Regulatory Business Services Branch
Branch Head: Ms Nicole McLay
- Undertakes finance, procurement, risk management and property services for the TGA.
Regulatory Knowledge and Technology Services Branch
Branch Head: Mr Peter Bickerton
- Manages the delivery of regulatory information technology and information management, records management and library services for the whole Department.
Regulatory Legal Services Branch
Branch Head: Ms Terry Lee
- Provides a range of legal services to support therapeutic goods regulation.
Regulatory Engagement, Education and Planning Branch
Branch Head: Mr Pio Cesarin
- Provides a strategic, coordinated approach to the management of the TGA's education and planning, parliamentary services, committee support, stakeholder and international engagement, cross-agency projects and human resources.
Regulatory Business Improvement Branch
Branch Head: Ms Judy Develin
- Coordinates and supports delivery of all TGA Regulatory Reform projects and reviews, including assessment of potential impacts of particular regulatory options.