Australia's Therapeutic Goods Administration to undergo a AU$12m digital transformation

It's expected to make it easier for medicines and medical devices to get the tick of approval.
Written by Aimee Chanthadavong, Contributor

Australia's Therapeutic Goods Administration (TGA) is getting a digital makeover, after the federal government announced on Friday it would invest AU$12 million over four years to make it happen.

As part of the revamp, TGA's business systems and infrastructure will be digitised and cybersecurity measures will be bolstered.

Specifically, it will enable medical companies to use automatic data transfer to deliver drug reaction reports on patient safety from their own internal databases into the TGA Adverse Events Management System (AEMS) database, saving up to 15 minutes per report. This will be a change to the current process that requires reports that are submitted in PDF format, as well as other formats, to be manually entered into the database. 

See also: ADHA details My Health Record breach attempt

Minister for Health Greg Hunt touted the revamp would help cut red tape for more than 4,000 businesses that apply to register medicines and medical devices annually, saying it would result in earlier approvals of medical products.

"The TGA receives around 26,000 applications every year for medicines and medical devices to be listed or amended on the Australian Register of Therapeutic Goods (ARTG), which allows them to be imported, sold, and used in Australia," he said.

"The digital changes will enable simpler and more secure interactions between government and industry to apply for, track, pay, and manage listings for regulated and subsidised health-related products and services."

The program is being delivered as part of the federal government's deregulation agenda, which has been designed to reduce the cost of doing business with government and performing regulatory compliance through targeted technology investment.

The agenda received just over AU$156 million when the Australian government handed down its 2019-20 Mid-Year Economic and Fiscal Outlook at the end of last year.

Earlier this week, the Morrison government announced as part of its AU$800 million Digital Business Package that cutting regulatory red tape will be one of its priorities. He added that the government has plans to dedicate AU$7 million in two blockchain pilots that aim to reduce business regulatory compliance costs and nearly AU$11.5 million for regtech commercialisation.

But red tape reduction is not only happening at the federal level. On Thursday, the New South Wales government launched its open-source rules-as-code platform to help industry and other government bodies digitise regulation for easier compliance.

The state government said through the platform, industry and other government bodies would be able to incorporate digital rules directly into their own IT systems and see any future rule changes be automatically applied.

The platform has launched with the digital version of the Community Gaming Regulation 2020, which identifies the conditions for running community games by charities, not-for-profits, and businesses.

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