Professor Tony Lawler is the Deputy Secretary of the Health Products Regulation Group, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production.  

Prior to joining the Department in June 2023, Tony was the Chief Medical Officer and Deputy Secretary- Clinical Quality, Regulation and Accreditation with the Tasmanian Department of Health. This role included providing leadership to health professionals, system-wide clinical governance oversight, and the regulation of private health service establishments.  

Having studied medicine at the University of Tasmania, Tony has worked in the health system as a Specialist Emergency Physician, Specialist Medical Administrator, and senior health public servant for almost 30 years. During the COVID-19 pandemic, Tony was the Tasmanian Health Service Emergency Operations Commander.  Tony has previously held positions as a member of the Board of the Australian Commission on Safety and Quality in Health Care and the Council of the National Health and Medical Research Council, President of the Australasian College for Emergency Medicine, and Deputy Head of the Tasmanian School of Medicine.   

Tony is a Professor in Health Services with the University of Tasmania.  

Stephen is the Director of the GMP Clearance section of the Manufacturing Quality Branch (MQB) and joined the TGA in January 2016.

The GMP Clearance section is responsible for the GMP evaluation of overseas manufacturing sites as part of a marketing authorisation application. With over 90% of medicines supplied to Australia coming from overseas, the section plays a crucial role in MQB’s goal of assisting in the timely supply of therapeutic goods ensuring they are of appropriate quality for their entire lifecycle. The section also has responsibility for the TGA’s inspection reliance framework which involves the ongoing assessment of other regulatory authorities’ GMP programs for equivalence.

Prior to joining the TGA, Stephen had over 10 years of experience in manufacturing facilities in both Europe and Australia across several categories of Therapeutic Goods including medical devices, biological drug substances, terminally sterilised and aseptic fill/finish operations and radiopharmaceuticals.

Stephen is also the chair of Pharmaceutical Inspection Cooperation Scheme (PIC/S) GMP Inspection Reliance Working Group leading efforts on increasing the use of inspection reliance practices across PIC/S participating authorities.