The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health. The TGA's offices are grouped into three major divisions - Market Authorisation Group, Monitoring and Compliance Group and Regulatory Support Group.
The TGA Executive has overall responsibility for the management of the TGA's regulatory functions and activities.
The TGA Executive comprises:
- TGA National Manager, Prof John Skerritt
- Principal Medical Adviser, Dr Tony Hobbs
- Principal Legal Adviser, Ms Philippa Horner
- Head, Market Authorisation Group, Dr Lisa Studdert
- Head, Monitoring & Compliance Group, Dr Larry Kelly
- Chief Operating Officer, Ms Samantha Palmer
The Market Authorisation Group (MAG) is responsible for undertaking evaluations of applications to approve new therapeutic products for supply in Australia. The MAG makes decisions whether to approve or reject market authorisation of medicines, medical devices and blood and tissues that are imported, exported, manufactured and supplied in Australia.
The Offices and Units in the MAG are:
Office of Medicines Authorisation (OMA)
Office Head: Dr Peter Bird
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: Mr Bill Turner
- 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.
- OSE is also responsible for approving biologicals.
Group Support Unit (GSU)
- The GSU is responsible for providing planning, coordination and administrative services to all areas of the Group.
The Monitoring and Compliance Group (MCG) is responsible for ongoing monitoring of therapeutic products approved for supply in Australia to ensure they meet the necessary standards throughout their lifecycle.
The way our medicines and devices are manufactured is also regulated by the TGA. Australian and international manufacturers must operate in a manner that results in products meeting specified standards if they are to be supplied in Australia. The TGA conducts regular inspections of manufacturers, both in Australia and overseas, to ensure they continue to meet these standards.
The Offices and Units in the MCG are:
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: Dr Mark McDonald
- 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: Dr Harry Rothenfluh
- The OMQ is responsible for ensuring manufacturers of medicines and medical devices meet appropriate standards of quality.
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.
Group Support Unit (GSU)
- The GSU is responsible for providing planning, coordination and administrative services to all areas of the MCG.
The Regulatory Support Group provides whole-of-agency regulatory support services that enable the TGA to undertake its regulatory responsibilities. This includes the legal, finance, information technology and information management, communications, parliamentary and human resource management services.
The Offices and Unit in the Regulatory Support Group are:
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)
Chief Information Officer: 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 Change and Program Management (OCPM)
Office Head: Ms Judy Develin
- The OPM coordinates and supports delivery of all TGA Reform projects, including all Blueprint, ANZTPA and TGA Project Register projects.
Office Head: Dr Cheryl McRae
Dr McRae reports directly to the TGA Executive through the National Manager. Responsibilities include:
- Finalisation of the implementation of the Business to Business projects
- Development of the Common Regulatory Framework, including development of the health regulatory Rules and Orders and conduct of regulatory harmonisation activities between TGA and Medsafe
- Development of cost recovery arrangements
- Development of a Single Entry Point e-Business web portal for ANZTPA to progressively cover all business engagement applications for industry
- Liaison with Medsafe and the Australian (and as appropriate New Zealand) industry on regulatory issues
- Lead Australia/New Zealand Policy Working Group on Transitional Arrangements, and participation in other Australia/New Zealand Policy Working
- Stakeholder consultations on the regulatory scheme and change management.
The OTA works closely with all other TGA offices as well as the ANZTPA Taskforce based in Woden, which lead policy analysis and advice to Government including bilateral negotiations with New Zealand on a range of "non-health" policy issues: development of the overarching ANZTPA legislative package; program management and reporting and provide a secretariat to ANZTPA governance committees and building of ANZTPA organisational structures, policies and systems.