2 February 2016

The Therapeutic Goods Administration is part of the Regulatory Services Group in the Australian Government Department of Health.

The Regulatory Services Group includes:

Regulatory Services Group Executive

The RSG Executive is:

  • Deputy Secretary, Adjunct Prof John Skerritt
  • Principal Medical Adviser, Dr Tony Gill (acting)
  • Principal Legal and Policy Adviser, Ms Philippa Horner PSM
  • Office of Gene Technology Regulator, Dr Jane Cook (acting)
  • Office of Chemical Safety, (incorporating NICNAS & AgVet Chemicals), Dr Brian Richards
  • First Assistant Secretary, Regulatory Practice and Support Division, Mr David Weiss
  • Therapeutic Goods Administration, Medicines Regulation Division, Ms Mary McDonald
  • Therapeutic Goods Administration, Medical Devices and Product Quality Division, Dr Larry Kelly

Information on the Executive structure of OGTR and OCS is available on their websites.

Therapeutic Goods Administration

The TGA has two regulatory divisions, the Medicines Regulation Division and the Medical Devices and Product Quality Division and a third support division, the Regulatory Practice and Support Division (RPSD). The RPSD provides regulatory support services that enable the Group to undertake its regulatory responsibilities.

Medicines Regulation Division

The Medicines Regulation Division evaluates applications to approve new medicines for supply in Australia. The division is also responsible for monitoring medicines approved for supply in Australia after they are on the market.

The Division includes:

Prescription Medicines Authorisation

Branch Head: Judy Develin

Complementary and Over-the-counter Medicines

Branch Head: Lyndall Soper

Scientific Evaluation

Branch Head: Dr Mariana Gebara-Coghlan A/g

  • Responsible for evaluating generic prescription medicines and biologicals. The branch includes experts in toxicology, biological sciences and pharmaceutical chemistry, and administers the regulation of internationally controlled drugs.

Pharmacovigilance and Special Access Branch

Branch Head: Steve Dunlop A/g

  • Oversight of medicines and vaccines to ensure they maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace. The branch also evaluates and authorises certain clinical trials and special access arrangements for all types of therapeutic products.

Medical Devices and Product Quality Division

The Medical Devices and Product Quality Division monitors medical devices approved for supply in Australia and works to ensure Australian and international therapeutic goods manufacturers meet specified standards.

The Division includes:

Medical Devices Branch

Branch Head: Dr Cheryl McRae

Laboratories Branch

Branch Head: Dr Peter Bird

  • Responsible for conducting laboratory testing, quality assessment and test procedure development in scientific disciplines such as microbiology, immunobiology, molecular biology, biochemistry, chemistry, and biomaterials engineering. The branch also contributes to the evaluation of a range of therapeutic products for market authorisation.

More information: Laboratories Branch

Manufacturing Quality Branch

Branch Head: Dr Harry Rothenfluh

  • Responsible for ensuring manufacturers of medicines, medical devices, as well as blood, tissue and cellular therapies, meet appropriate quality standards. This involves both the physical inspection of manufacturing facilities in Australia and abroad as well as provision of clearances for facilities where suitable inspections have been carried out by comparable overseas regulators. The branch also coordinates product recalls when necessary and provides technical advice to support Medicines Regulation Division's decisions, particularly on matters relating to manufacturing practice and quality management.

Regulatory Practice and Support Division

The Regulatory Practice and Support Division which provides operational regulatory policy advice and specific support services that ensure efficient, best practice regulatory operations to the Regulatory Services Group.

The Division includes:

Regulatory Services and Improvement Branch

Branch Head: Nicole McLay

  • Responsible for activity-based pricing, regulatory billing and industry assistance, project and change management and regulatory decision reviews. The branch also provides regulatory information assistance and develops regulatory guidance for industry. The branch also leads the Business Improvement Programme to streamline and automate regulatory processes.

Regulatory Practice, Education and Compliance Branch

Branch Head: Pio Cesarin

  • Responsible for regulatory compliance activities, including education, advertising, enforcement and investigations into illegal and counterfeit therapeutic goods. The branch also undertakes regulatory impact analysis and supports good regulatory practice through research and impact analysis of proposed regulatory reforms.

Regulatory Engagement and Planning Branch

Branch Head: Avi Rebera

  • Responsible for managing engagement with international regulators, planning and performance reporting, parliamentary processes, media responses, coordination of technical input for Freedom of Information requests, stakeholder engagement, and committee support.