Inquiry considers national approval process for new medicines

By Melissa Coade

April 22, 2021

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The ACCC has warned it RAT price gougers have been referred to police (Image: Adobe/ Tyler Olson)

The development of new drugs and novel therapies will be the focus of a two-day public hearing held in Melbourne before the Standing Committee on Health and Aged Care and Sport.

The standing committee will hear evidence from patient advocacy groups, pharmaceutical companies, research bodies and clinical trial centres over Thursday and Friday. To date, 185 submissions to the inquiry have been made.

Committee chair Trent Zimmerman said the Melbourne hearings would consider the repurposing of drugs to treat new conditions, and new innovative drugs and novel therapies that are being developed in Australia and overseas.

“The committee will continue to hear from stakeholders to find out how Australia’s approval systems and funding for new medicines and novel medical technologies will provide the best possible outcomes for all Australians now and into the future,” Mr Zimmerman said.

“Two other important aspects to be reviewed include making the approvals process for new drugs and novel medical technologies more efficient, and consideration as to how Australia could be a more attractive location for clinical trials.”

Health minister Greg Hunt referred the committee to inquire into approval processes for new drugs and novel medical technologies in Australia last August.

A health department submission to the inquiry in October said that the median assessment time for new prescription medicine or major variation to an existing medicine was 162 working days, an improvement of 20 days since the last financial year. This improvement in assessment time was achieved even though there were an additional 24 applications since the last financial year.

“The Therapeutic Goods Administration (TGA) understands that knowing more about the pipeline of applications coming to it, the time for pre‐submission preparation and potential TGA review time will help expedite the approval process where possible,” the health department said. 

“This has been particularly useful in the current environment with the COVID‐19 pandemic.”

The inquiry’s terms of reference indicate the committee will give special focus to medical advances for the treatment of rare diseases and conditions where there is high and unmet clinical need.

Future hearings have been scheduled to take place in Sydney and Brisbane next month. The inquiry continues to accept submissions from stakeholders.

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