$12m boost for TGA to upgrade IT systems

The Therapeutic Goods Administration (TGA) will spend $12 million over four years to digitise, transform and modernise its business systems and infrastructure, and better connect services to get medicines and devices to patients sooner.

This will also make it easier for businesses applying to register medicines and medical devices, thereby improving the timeliness of reporting on patient safety.

The TGA’s new digital processes will deliver simpler and faster interactions between industry and government. This means earlier approvals of medical products, reduced administrative effort and timelier decision-making by the TGA.

The revamp will yield a significant reduction in red tape and cut costs for the medicines and medical devices industry. It will also enable faster access to emerging and new health technologies in the international market.

The TGA receives around 26,000 applications annually 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.

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 TGA receives 15,000 adverse drug reaction reports on patient safety per year, which are entered manually through PDF rather than through a central database.

The digital reforms will enable medical companies to use an electronic database to report these patient safety events with automatic data transfer, saving approximately 15 minutes per report.

With the modernisation of the TGA’s business systems and infrastructure, consumers and healthcare professionals can also have greater confidence in the safety and efficacy of therapeutic goods. Cybersecurity will also be bolstered to ensure the protection of commercial-in-confidence information from industry.

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