A range of digital reforms are being made to the Therapeutic Goods Administration (TGA) to cut red tape and make life easier for the 4,000 or so businesses that apply to TGA to register medicines and medical devices each year.
Announced by the Minister for Health, Greg Hunt the reforms are part of the Deregulation Agenda aimed at improving the timeliness of reports on patient safety.
Mr Hunt said $12 million had been allocated to digitise and modernise the TGA’s business systems and infrastructure, in order to better connect services to get medicines and devices to patients sooner.
“New digital processes will deliver simpler and faster interactions between industry and government,” Mr Hunt said.
“This means earlier approvals of medical products, reduced administrative effort, and timelier decision-making by the TGA,” he said.
Mr Hunt said the Deregulation Agenda would yield a significant reduction in red tape and cut costs for the medicines and medical devices industry.
“It will also position Australia to more quickly access emerging and new health technologies in the international market,” 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.”
He said the TGA received 15,000 adverse drug reaction reports on patient safety per year which were entered manually through PDF rather than through a central database.
“With these reforms, medical companies will now be able to use an electronic database to report these patients safety events with automatic data transfer – saving them up to 15 minutes per report,” Mr Hunt said.
