The Therapeutic Goods Administration is part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health.
The Executive is:
- Deputy Secretary, Adjunct Prof John Skerritt
- Principal Medical Adviser, Dr Tony Gill A/g
- Principal Legal and Policy Adviser, Philippa Horner PSM
- First Assistant Secretary, Regulatory Practice and Support Division, David Weiss
- Therapeutic Goods Administration, Medicines Regulation Division, Dr Larry Kelly
- Therapeutic Goods Administration, Medical Devices and Product Quality Division, Adriana Platona A/g
Therapeutic Goods Administration
Medicines Regulation Division
The Medicines Regulation Division evaluates applications to approve new medicines for supply in Australia. The division is also responsible for monitoring medicines approved for supply in Australia after they are on the market.
The Division includes:
Prescription Medicines Authorisation
Branch Head: Adrian Bootes
- Responsible for evaluating new prescription medicines, leading to an approval or rejection decision.
Complementary and Over-the-counter Medicines
Branch Head: Lyndall Soper
- Responsible for regulating over the counter medicines as well as complementary medicines, which include traditional and herbal medicines, and vitamin and mineral supplements.
Branch Head: Dr Mayada Kayali A/g
- Responsible for approving applications to market biologicals and generic medicines in Australia. The Branch also provides scientific advice to support the decisions made by the Medicines Regulation Division, in particular evaluating the toxicological and pharmaceutical chemistry aspects of therapeutic products and provide expertise in the biological sciences.
Pharmacovigilance and Special Access Branch
Branch Head: Steve Dunlop A/g
- Oversight of medicines and vaccines to ensure they maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace. The branch also evaluates and authorises certain clinical trials and special access arrangements for all types of therapeutic products.
Medical Devices and Product Quality Division
The Medical Devices and Product Quality Division monitors medical devices approved for supply in Australia and works to ensure Australian and international therapeutic goods manufacturers meet specified standards.
The Division includes:
Medical Devices Branch
Branch Head: Dr Cheryl McRae
- Responsible for evaluating medical devices, including in vitro diagnostic tests, and monitoring them throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety and performance.
Branch Head: Michael Wiseman
- Responsible for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines such as microbiology, immunobiology, molecular biology, biochemistry, chemistry, and biomaterials engineering. The branch also contributes to post market monitoring and the evaluation of a range of therapeutic products for market authorisation.
Manufacturing Quality Branch
Branch Head: Dr Harry Rothenfluh
- Responsible for ensuring manufacturers of medicines, medical devices, as well as blood, tissue and cellular therapies, meet appropriate quality standards. This involves both the physical inspection of manufacturing facilities in Australia and abroad as well as provision of clearances for facilities where suitable inspections have been carried out by comparable overseas regulators. The branch also coordinates product recalls when necessary and provides technical advice to support Medicines Regulation Division's decisions, particularly on matters relating to manufacturing practice and quality management.
Regulatory Practice and Support Division
The Regulatory Practice and Support Division which provides operational regulatory policy advice and specific support services that ensure efficient, best practice regulatory operations to the Health Products Regulation Group.
The Division includes:
Regulatory Services and Improvement Branch
Branch Head: Nicole McLay
- The branch is responsible for the TGA Program Office, enquiry management through the regulatory assistance section, activity-based pricing and billing, business systems help desk, and the coordination of internal reviews of regulatory decisions. The branch also provides administrative assistance to the three TGA divisions.
Regulatory Practice, Education and Compliance Branch
Branch Head: Pio Cesarin
- Responsible for regulatory compliance activities, including education, advertising, enforcement and investigations into illegal and counterfeit therapeutic goods. The branch also undertakes regulatory impact analysis and supports good regulatory practice through research and impact analysis of proposed regulatory reforms.
Regulatory Engagement and Planning Branch
Branch Head: Avi Rebera
- Responsible for managing stakeholder engagement with international regulators, regulatory guidance material, planning and performance reporting, parliamentary processes, media responses, coordination of technical input for Freedom of Information requests and committee support.
Office of Drug Control
Assistant Secretary: Bill Turner
- The Office of Drug Control (ODC) regulates and provides advice on the import, export and manufacture of controlled drugs to support Australia's obligations under the Narcotic Drugs Conventions. The ODC is responsible for ensuring the Australian public have access to essential medications while supporting government drug policy on harm minimisation. This includes administering licenses for access to controlled drugs and implementing the regulatory framework pertaining to the cultivation and manufacture of medicinal cannabis.