Independent review of TGA provides sensible solutions to accelerate access to new Medicines

Medicines Australia welcomes the recommendations of an independent review into the Therapeutic Goods Administration (TGA) which, if adopted, will help to cut time delays and improve Australian’s access to new, innovative medicines.

The Review examined the TGA’s regulatory framework and processes with a view to identifying areas of unnecessary red tape and opportunities to enhance and streamline the regulatory framework.

Medicines Australia CEO, Tim James, welcomed the Report and said the industry is keen to work with the Government to ensure that Australia both maintains and evolves our current world class system.

“It’s pleasing to see that many of the recommendations proposed by Medicines Australia have been adopted in this report,” said Mr James.

“Encouraging work sharing with overseas regulators, accelerated approval pathways and retaining the capacity of the TGA to undertake assessments of therapeutic goods are sensible proposals and it’s good to see that this independent report agrees.”

“Medicines Australia agrees that targeted reform is required so that the Australian regulatory system can better serve the Australian community and that any changes proposed to the current system must firstly be focussed on ensuring the internationally recognised standard for regulation in Australia is retained.”

“We also need to make sure that the TGA has the necessary resources to deliver continuous improvement to approval processes to keep pace with medical breakthroughs and developments.”

“While we welcome the report and once again applaud the Government for bringing about this review, there have been some missed opportunities for further improvements to the TGA registration process. Medicines Australia has repeatedly raised concerns about delays in access arising from the TGA’s burdensome pre-submission period. This results in an approval timeframe that starts at least three months later than those of comparable global agencies.”

“There are many other impediments which slow down the process of getting a new medicine to patients in Australia which need to be addressed.”

“Medicines Australia’s 2015 COMPARE Report found that Australia is ranked 18 out of 20 OECD countries for access to new medicines.”

“Since 2009, just 40 per cent of new medicines approved by regulatory bodies have been made available on the Pharmaceutical Benefits Scheme (PBS) in Australia.”

“For those new medicines that do make it, the time from TGA approval to PBS listing takes on average more than a year. In most OECD countries this process happens within 6 months.”

“Changing government policy also plays a role in delaying medicine access for Australians. This includes PBS pricing cuts within the last Federal Budget, changes to Research and Development tax rules and delays in clinical trial reform which reduce competitiveness.”

“Meaningful and sustainable reform can be achieved through a strong and collaborative relationship between industry, government and the community. These partnerships are critical to ensuring a globally harmonised approach to regulation that facilitates timely access to new medicines for the Australian health consumer.”


James Boyce
Phone: 0423 239 265

Alexia Vlahos
Phone: (02) 6122 8503