The Australian Government is making significant digital reforms to the Therapeutic Goods Administration (TGA) to cut red tape for more than 4,000 businesses applying to register medicines and medical devices each year, as part of its Deregulation Agenda which will also improve the timeliness of report on patient safety.
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. 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.
Under this Deregulation Agenda, the Government is focused on ensuring regulation is and remains fit-for-purpose – making it easier to do business while ensuring essential safeguards with the lightest touch. This measure will yield a significant reduction in red tape, cutting 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.
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.
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.
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. All Australians will benefit from a streamlined process which increases the timeliness of decisions on the safety, quality and efficacy of therapeutic goods, and their approval for listing on the ARTG.
Consumers and health care professionals can also have greater confidence in the safety and efficacy of therapeutic goods, with increased transparency built into the reforms. Cybersecurity will also be bolstered to ensure the protection of commercial-in-confidence information from industry.
Australia’s Deregulation Agenda
The Australian Government is committed to busting regulatory congestion and removing obstacles to business investment The Government has made deregulation a key priority. It previously achieved over $5.8 billion of savings from 2013 to 2016 through its Cutting Red Tape Agenda.
The government has now embarked on a new Deregulation Agenda to continue to remove impediments to business investment and job creation, establishing a Deregulation Taskforce to drive improvements to the design, administration and effectiveness of the stock of regulation to ensure that it is fit-for-purpose.
The Taskforce has already looked at three key areas: making it easier for sole traders and microbusinesses to employ their first-person; getting beneficial major projects up and running sooner, and reducing the regulatory burden for food manufacturers with an initial focus on exporting.
The Taskforce’s primary focus is to identify barriers to investment and job creation from the perspective of business, and then to work with business and agencies to co-design solutions across jurisdictions. This includes exploring opportunities to use ‘regtech’ to make it easier for businesses to identify their compliance obligations and engage with the Government.
