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.
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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