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TGA structure

The TGA is part of the Health Products Regulation Group (HPRG). See details of our branches and divisions.

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We are part of the Australian Government Department of Health and Aged Care's Health Products Regulation Group (HPRG). HPRG includes the Therapeutic Goods Administration (TGA) and the Office of Drug Control (ODC).

HPRG Executive

  • Deputy Secretary – Prof Tony Lawler
  • Chief Medical Adviser – Adj Prof Robyn Langham
  • Principal Legal and Policy Adviser – Dr Bridget Gilmour-Walsh
  • First Assistant Secretary, Medicines Regulation Division – Nick Henderson 
  • First Assistant Secretary, Medical Devices and Product Quality Division – Tracey Duffy
  • First Assistant Secretary Regulatory Practice and Support Division – Chris Bedford

Regulatory Legal Services

Principal Legal and Policy Adviser: Dr Bridget Gilmour-Walsh

We provide high quality and timely solutions-focussed legal services to the TGA. We also assist the ODC to support regulatory decisions, including:

  • implementation of business and legislative reforms
  • compliance and enforcement activities.

The Principal Legal and Policy Adviser is also responsible for providing:

  • leadership in delivering legally robust outputs for the regulatory process
  • reviewing the legislative framework against government and stakeholders expectations of our regulatory functions
  • coordinating technical input for Freedom of Information (FOI) requests.

Medicines Regulation Division

Our responsibility is to:

  • evaluate applications to approve new medicines for supply in Australia
  • undertake safety monitoring of medicines and vaccines approved for supply in Australia after they are on the market.

Prescription Medicines Authorisation

Branch Head: Andrew Simpson

We are responsible for evaluating new prescription medicines, leading to an approval or rejection decision.

Complementary and Over-the-Counter Medicines

Branch Head: Avinash Clarke
We are responsible for regulating:

Scientific Evaluation

Branch Head: Dr George Vuckovic

We are responsible for:

  • approving applications to market biologicals and generic medicines in Australia
  • providing scientific advice to support the decisions made by the Medicines Regulation Division.

This includes:

  • evaluating toxicological and pharmaceutical chemistry aspects of therapeutic products
  • providing expertise in the biological sciences.

Pharmacovigilance Branch

Branch Head: Dr Claire Larter A/g

We are responsible for:

  • overseeing medicines and vaccines to ensure they maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace
  • evaluating and authorising certain clinical trials for all types of therapeutic products
  • helping to monitor and manage medicine shortages
  • supporting the Governments COVID-19 vaccine compensation scheme.

International Regulatory Branch

Branch Head: Michael Wiseman

We are responsible for delivering two DFAT-funded aid programs:

  • Regulatory Strengthening Program for regional medicines regulators
  • Australian Expert Technical Advisory Program – Regulatory Support and Safety Monitoring for COVID-19 vaccine delivery in the region.

We also support:

  • the Asian Development Bank with their work to access and increase supply of vaccines for Developing Member Countries
  • 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 Prescribers schemes.

Medical Devices and Product Quality Division

We regulate 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
  • auditing and certifying manufacturers against manufacturing standards so the products they produce meet appropriate quality, safety and performance standards.

Medical Devices Authorisations Branch

Branch Head: John Jamieson

We are responsible for assessing and approving medical devices including in-vitro medical devices for supply in Australia to ensure they meet Australian regulatory requirements. This protects the health and safety of Australian consumers.

Medical Devices Surveillance Branch

Branch Head: Dr Marcelle Noja

We are responsible for monitoring medical devices throughout their lifecycle to ensure they continue to meet an appropriate level of quality, safety and performance. Devices include:

  • emerging technologies
  • in-vitro diagnostics (IVDs)
  • other therapeutic goods (OTGs).

We do this by:

  • undertaking complex monitoring, analysis, investigation and review activities
  • keeping abreast of emerging technology and adoption in medical devices.

Laboratories Branch

Branch Head: Dr Lisa Kerr

We are responsible for conducting laboratory testing, quality assessment and test procedure development in disciplines such as:

  • microbiology
  • immunobiology
  • molecular biology
  • biochemistry
  • chemistry
  • biomaterials engineering.

We also contribute to post market monitoring and the evaluation of a range of therapeutic products for market authorisation, including vaccines and biologicals. Learn more about the TGA Laboratories.

Manufacturing Quality Branch

Branch Head: Hongxia Jin

We are responsible for ensuring manufacturers of medicines, and blood, tissue and cellular therapies meet appropriate quality standards. This involves:

  • the physical inspection of manufacturing facilities in Australia and abroad
  • provision of clearances for facilities where suitable inspections have been carried out by comparable overseas regulators.

We also:

  • coordinate therapeutic product recalls when necessary
  • provide technical advice to support Medicines Regulation Division's decisions.

This includes on matters relating to manufacturing practice and quality management.

Regulatory Practice and Support Division

We provide operational regulatory policy advice and specific support services to HPRG. This ensures efficient, best practice regulatory operations.

Office of Drug Control 

Branch Head: Avi Rebera

We are responsible for a range of functions including:

  • activity-based pricing and billing
  • business system help desk
  • coordinating internal reviews of regulatory decision, labour hire and procurement
  • regulatory impact statement advice
  • data analytics support.

Our branch also includes the Office of Drug Control (ODC). We regulate and provide 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
  • implementing the regulatory framework pertaining to the cultivation, production and manufacture of medicinal cannabis.

Digital Transformation Branch

Branch Head: Ms Terri Dreyer

We are responsible for: 

  • Leading digital transformation across the TGA, including delivery of new portal and case management solutions 
  • Supporting transition overtime from older legacy systems to modern digital platforms that make it more efficient for staff and industry to utilise
  • Working closely with Office of Drug Control (ODC) colleagues, leveraging new portal and case management solutions to support their transformation program  

We do this by:

  • Collaborating with internal and external stakeholders throughout the transformation
  • Focusing on end-to-end development, utilising agile and user-centred design methods to deliver high quality products 
  • Providing advice to the HPRG Transformation Board on digital and IT work that falls outside the program, to support alignment with the target operating model

Vaping Implementation and Enforcement Branch

Branch Head: Nicole McLay

We are responsible for compliance and enforcement concerning vaping goods and other nicotine-containing therapeutic goods including:

  • supporting the seizure of unlawfully imported goods at the border by the Australian Border Force, and leading escalated enforcement actions concerning unlawful importation
  • leading the monitoring and enforcement of advertising and manufacturing controls 
  • supporting states and territories with their compliance and enforcement activities concerning wholesale supply, retail supply and commercial possession. 
  • supporting the department’s vaping regulatory reforms and smoking cessation program, 
  • supporting the importation and supply of compliant therapeutic vapes to meet consumer needs for the purpose of smoking cessation or nicotine dependence.

We do this by:

  • Working with stakeholders across Commonwealth, state and territory governments, and industry and community groups to help design, implement and collaboratively enforce Australia’s policy response concerning vapes, including coordinating the National Vaping Working Group and the development of a National Vaping Enforcement Framework. 
  • Executing search warrants, undertaking compliance monitoring and investigations, and progressing infringement notices, court actions and other actions under the Therapeutic Goods Act in relation to unlawful vape importation, advertising, supply and manufacturing 
  • Engaging directly with stakeholders involved in the lawful therapeutic vape supply chain, including managing sponsor notifications of therapeutic vape compliance with TGA standards.

Regulatory Compliance Branch

Branch Head: Tracey Lutton

We are responsible for regulatory compliance activities relating to the offence provisions of the Therapeutic Goods Act 1989, including:

  • intelligence
  • compliance
  • enforcement action.

This includes unlawful advertising, import, export, manufacturing, and supply of therapeutic goods.

Regulatory Engagement Branch

Branch Head: Shari Krasowski A/g

We are responsible for providing a range of policy advice, communication and support services for TGA, including:

  • regulatory guidance and education materials
  • planning and performance reporting
  • parliamentary processes
  • media responses
  • external events and webinar programs
  • library services
  • scheduling relating to the Poisons Standard
  • committee support.

We also manage:

  • social media
  • stakeholder engagement with international regulators
  • the TGA enquiries helpdesk.

More information

 

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