We are part of the Australian Government Department of Health and Aged Care Department of Health and Aged Care’s Health Products Regulation Group (HPRG). The HPRG also includes the Office of Drug Control (ODC).
HPRG Executive
-
Deputy Secretary – Adjunct Prof. John Skerritt
- Chief Medical Adviser – Dr 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 – Gillian Mitchell
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: Dr Cheryl McRae
We are 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 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 Head: Elspeth Kay
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 shortages
- supporting the Government’s COVID-19 vaccine compensation scheme.
International Regulatory Branch
Branch Head: Michael Wiseman
We are responsible for delivering 2 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 Prescriber 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 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: Kate McCauley
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: Jenny Burnett
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.
Regulatory Services and Drug Control Branch
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.
Regulatory Compliance Branch
Branch Head: Nicole McLay
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: Ben Noyen
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:
- TGA and ODC websites
- social media
- stakeholder engagement with international regulators
- the TGA enquiries helpdesk.
More information
- View our TGA plans and reports
- View our Publications
- Learn about Freedom of information