Leadership and business divisions

We are part of the Australian Government Department of Health, Disability and Ageing'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 – Prof Robyn Langham
• First Assistant Secretary, Regulatory Legal Services Division – Dr Bridget Gilmour-Walsh PSM
• 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 Division

This division provides a range of legal and freedom of information (FOI) services to support the regulatory functions of the HPRG. This includes providing advice to Portfolio Ministers, Ministers’ offices and the HPRG Executive. The legal branches strategically manage legal risks to enable HPRG to deliver its strategic priorities. 

Legislation, Advice and FOI Branch

Branch head: Dave Fintan

This branch is responsible for providing legal advice to HPRG, as well as developing legislation, managing FOI processes and managing internal merits review of regulatory decisions for HPRG.

Dispute Resolution, Compliance and Commercial Branch

Branch head: Sascha Gelfand

This branch is responsible for providing advice on compliance and commercial matters to HPRG, as well as managing litigation for HPRG.

Medicines Regulation Division

This division’s 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

Branch head: Andrew Simpson

This branch is responsible for evaluating new prescription medicines, leading to an approval or rejection decision.

Complementary and Over-the-Counter Medicines Branch

Branch head: Avinash Clarke

This branch is responsible for regulating:

• over-the-counter (OTC) medicines
• listed medicines
• assessed listed medicines
• registered complementary medicines (including traditional and herbal medicines, and vitamin and mineral supplements).

Scientific Evaluation Branch

Branch head: Dr George Vuckovic

This branch is 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 Tahli Fenner A/g

This branch is 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 Australian Government’s COVID-19 vaccine compensation scheme.

International Regulatory Branch

Branch head: Michael Wiseman

This branch is responsible for delivering the Regulatory Strengthening Program, which is an aid program for regional medicines regulators, funded by the Department of Foreign Affairs and Trade. It also supports the Asian Development Bank with their work to access and increase supply of vaccines for developing member countries.

This branch also includes the Special Access Section, which is responsible for the Special Access and Authorised Prescribers schemes.

Medical Devices and Product Quality Division

This 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
• 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

This branch is 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

This branch is responsible for monitoring medical devices throughout their life cycle to ensure they continue to meet an appropriate level of quality, safety and performance. Devices include:

• emerging technologies
• in-vitro diagnostics
• other therapeutic goods.

It does 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

This branch is responsible for conducting laboratory testing, quality assessment and test procedure development in disciplines such as:

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

It also contributes to post-market monitoring and the evaluation of a range of therapeutic products for market authorisation, including vaccines and biologicals. Learn more about our laboratories.

Manufacturing Quality Branch

Branch head: Stephen Farrell A/g

This branch is 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.

It also:

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

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

Regulatory Practice and Support Division

This division provides 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

This branch is responsible for a range of functions, including:

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

This branch also includes the Office of Drug Control (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
• implementing the regulatory framework pertaining to the cultivation, production and manufacture of medicinal cannabis.

Digital Branch

Branch head: Cindy Toms

This branch is responsible for: 

• leading digital transformation across the TGA, including delivery of new portal and case management solutions
• supporting transition over time from older legacy systems to modern digital platforms that are more efficient for staff and industry to use
• working closely with Office of Drug Control (ODC) colleagues, leveraging new portal and case management solutions to support their transformation program.

It does this by:

• collaborating with internal and external stakeholders throughout the transformation
• focusing on end-to-end development, using 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: Ashley McLachlan-Bent A/g

This branch is 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.

It does 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 1989 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

This branch is 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: Sarah Syme

This branch is responsible for providing a range of policy advice, communication and support services, 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.

It also manages:

• social media
• stakeholder engagement with international regulators
• our enquiries helpdesk.