Update on TGA Digital Transformation Program

On October 2nd, 2020, Minister Hunt announced the Australian Government is investing to digitise, transform and modernise the TGA business systems and infrastructure. The Government is investing $12 million over four years to digitise, transform and modernise the TGA’s business systems and infrastructure, better connecting services to get medicines and devices to patients sooner. These changes aim to deliver simpler and faster interactions between industry and government resulting in reduced regulatory burden for industry, earlier approvals of therapeutic goods, reduced administrative effort, and timelier decision-making by the TGA.

After initial workshops with industry held in Sydney on October 15, 2019, the TGA Digital Transformation Program has now clearly defined key outcomes, benefits, objectives and deliverables. Recently TGA provided an update and invited further industry comments during workshops with industry held on November 26 and 30, 2020. According to George Masri, Assistant Secretary | Regulatory Services and Drug Control Branch, “We wanted to take the opportunity to discuss what we have heard to date from industry stakeholders through various forums on how we could improve your overall experience interacting with the TGA, get your input on what you think our priorities should be for the program, and present our focus and our high-level roadmap for the program.“

The TGA Digital Transformation Project is also firmly embedded in TGA’s 2020-21 Business Plan, “to streamline our business systems and modernise IT infrastructure. This will benefit industry through facilitating simpler, faster interactions with the TGA while reducing our administrative effort, therefore increasing our ability to provide timely information and decisions. It will also allow for greater transparency in the regulation of medicines and medical devices, which should improve consumer confidence and benefit health care professionals.”

MTAA remains strongly supportive of TGA’s Digital Transformation Program and this was demonstrated by strong member participation - from Medtronic, Abbott, Baxter, Fresenius, Zimmer Biomet and Teleflex - in this latest round of workshops.