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9 August 2022

The Therapeutic Goods Administration is part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health.

HPRG includes the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

The HPRG Executive is:

  • Deputy Secretary, Adjunct Prof John Skerritt
  • Principal Legal and Policy Adviser, Dr Bridget Gilmour-Walsh
  • Chief Medical Adviser, Dr Robyn Langham
  • First Assistant Secretary, Medicines Regulation Division, Nick Henderson A/g
  • First Assistant Secretary, Medical Devices and Product Quality Division, Tracey Duffy
  • First Assistant Secretary Regulatory Practice and Support Division, Gillian Mitchell

Regulatory Legal Services

Principal Legal and Policy Adviser: Dr Bridget Gilmour-Walsh

Regulatory Legal Services provides high quality, timely, solutions focussed legal services to TGA and to assist the ODC to support regulatory decisions, including the implementation of business and legislative reforms and compliance and enforcement activities.

In addition to leading the Regulatory Legal Services, the Principal Legal and Policy Adviser is responsible for providing leadership in delivering outputs of the regulatory process that are legally robust and in reviewing the legislative framework against the expectations that government and stakeholders have of HPRG's regulatory functions.

Medicines Regulation Division

The Medicines Regulation Division evaluates applications to approve new medicines for supply in Australia. The division is also responsible for the safety monitoring of medicines and vaccines approved for supply in Australia after they are on the market.

The Division includes:

Prescription Medicines Authorisation

Branch Head: Andrew Simpson

Complementary and Over-the-counter Medicines

Branch Head: Dr Cheryl McRae

Scientific Evaluation

Branch Head: Dr George Vuckovic

  • 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 Branch

Branch Head: Elspeth Kay

  • Responsible for the 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 for all types of therapeutic products. It also has a role in the monitoring and management of medicines shortages and supports the Governments COVID-19 vaccine compensation scheme.

International Regulatory Branch

Branch Head: Michael Wiseman

  • Responsible for delivering two DFAT-funded aid programs - the Regulatory Strengthening Program for regional medicines regulators and the Australian Expert Technical Advisory Program – Regulatory Support and Safety Monitoring for COVID-19 vaccine delivery in the region. In addition, it supports the Asian Development Bank with their work to access and increase supply of vaccines for Developing Member Countries, and support the Australian Government opening of international borders through certification of vaccines and vaccination certificates. This Branch also includes the Experimental Products Section responsible for the Special Access and Authorised Prescriber schemes.

Medical Devices and Product Quality Division

The Medical Devices and Product Quality Division regulates the quality of therapeutic products for the Australian community by: assessing medical devices, including in vitro diagnostic tests; testing and monitoring medical devices and medicines to help ensure they continue to meet appropriate levels of quality, safety and performance; and auditing and certifying manufacturers against manufacturing standards so the products they produce meet appropriate quality, safety and performance standards.

The Division includes:

Medical Devices Authorisations Branch

Branch Head: John Jamieson

  • Responsible for the assessment and approval of medical devices for supply in Australia to ensure these devices meet Australian regulatory requirements. The assessment of the quality, safety and performance of medical devices including in vitro medical devices protects the health and safety of Australian consumers.

Medical Devices Surveillance Branch

Branch Head: Kate McCauley

  • Responsible for monitoring medical devices, including emerging technologies, in vitro diagnostics (IVDs) and other therapeutic goods (OTGs), throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety and performance. This is done by undertaking complex monitoring, analysis, investigation and review activities, and keeping abreast of emerging technology and adoption in medical devices.

Laboratories Branch

Branch Head: Dr Lisa Kerr

  • Responsible for conducting laboratory testing, quality assessment and test procedure development in 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, including vaccines and biologicals.

More information: TGA Laboratories

Manufacturing Quality Branch

Branch Head: Jenny Burnett

  • Responsible for ensuring manufacturers of medicines, 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 therapeutic 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 provides operational regulatory policy advice and specific support services to HPRG which ensure efficient, best practice regulatory operations.

The Division includes:

Regulatory Services and Drug Control Branch

Branch Head: Avi Rebera

  • Responsible for a range of TGA functions including activity-based pricing and billing, business system help desk, the coordination of internal reviews of regulatory decision, labour hire and procurement, regulatory impact statement advice and data analytics support.
  • The Branch also includes the ODC which regulates and provides advice on the import, export and manufacture of controlled drugs to support Australia's obligations under the Narcotic Drugs Conventions. This includes administering licenses for access to controlled drugs and implementing the regulatory framework pertaining to the cultivation, production and manufacture of medicinal cannabis.

Regulatory Compliance Branch

Branch Head: Nicole McLay

  • Responsible for regulatory compliance activities, including intelligence, and compliance and enforcement action relating to the offence provisions of the Therapeutic Goods Act 1989 including unlawful advertising, import, export, manufacturing and supply of therapeutic goods.

Regulatory Engagement Branch

Branch Head: Ben Noyen

  • Responsible for providing a range of policy advice, communication and support services for the Group, including regulatory guidance and education materials, planning and performance reporting, parliamentary processes, media responses, external events and webinar program, library services, the scheduling relating to the Poisons Standard, coordination of technical input for Freedom of Information requests and committee support.
  • The Branch is also responsible for managing TGA and ODC websites, social media, stakeholder engagement with international regulators and the provision of a dedicated enquiries help desk for the Therapeutic Goods Administration.