TGA structure

Office of Medicines Authorisation (OMA)

Office Head (Acting): Dr Peter Bird

• The OMA is responsible for approving prescription and non-prescription medicines.

Office of Complementary Medicines (OCM)

Office Head: Ms Trisha Garrett

• The OCM is responsible for approving complementary medicines, including traditional and herbal medicines and vitamin and mineral supplements.

Office of Devices Authorisation (ODA)

Office Head: Ms Andrea Kunca

• The ODA is responsible for approving medical devices, including in vitro diagnostic medical devices (IVDs).

Office of Scientific Evaluation (OSE)

Office Head: Dr Mark McDonald

• The OSE provides scientific advice to support the decisions made by the Market Authorisation Group.
• This includes clinical, toxicological, biological sciences and pharmaceutical chemistry evaluation of therapeutic products.
• It also includes the Experimental Products Unit which is responsible for the evaluation and authorisation of certain clinical trials and special access arrangements for all types of therapeutic products.

Group Support Unit (GSU)

• The GSU is responsible for providing planning, coordination and administrative services to all areas of the Group.

Office of Product Review (OPR)

Office Head: Dr Jane Cook

• The OPR is responsible for overseeing all therapeutic products to ensure they continue to maintain an appropriate level of quality, safety, efficacy and performance following entry into the Australian marketplace.
• This includes monitoring reports of adverse events and reviewing medicine ingredients and device components.
• The Advertising and Recalls Unit also sits within OPR and is responsible for administering legislative requests for the advertising of therapeutic goods in Australia and coordinating product recalls when necessary.

Office of Laboratories and Scientific Services (OLSS)

Office Head (Acting): Dr Scott Craig

• The OLSS is responsible for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines such as, microbiology, immunobiology, molecular biology, biochemistry, chemistry, and biomaterials and engineering.

Office of Manufacturing Quality (OMQ)

Office Head: Mr Bill Turner

• The OMQ is responsible for ensuring manufacturers of medicines and medical devices meet appropriate standards of quality.

Group Support Unit (GSU)

• The GSU is responsible for providing planning, coordination and administrative services to all areas of the MCG.

Office of Corporate Services

Chief Financial Officer: Ms Nicole McLay

• The OCS undertakes finance, procurement, risk management and property services for the TGA.

Office of Information Management (OIM)

Office Head: Mr Peter Bickerton

• The OIM manages the delivery of information technology and information management, records management and the TGA library.

Office of Legal Services (OLS)

Office Head: Ms Terry Lee

• The OLS provides a full range of legal services for the TGA.

Office of Parliamentary and Strategic Support (OPSS)

Office Head: Mr Pio Cesarin

• The OPSS provides a strategic, coordinated and whole of agency approach to the management of the TGA's communications, parliamentary services and committee support, stakeholder and international engagement, cross-agency projects, reforms to the TGA's regulatory operations, and human resources.

Office of Program Management (OPM)

Office Head (Acting): Mr Bruce Kruttschnitt

• The OPM coordinates and supports delivery of all TGA Reform projects, including all Blueprint, ANZTPA and TGA Project Register projects.

Regulatory Compliance Unit

• The Regulatory Compliance Unit is responsible for on-going surveillance, enforcement and related activities, including investigations into illegal and counterfeit therapeutic goods.