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Industry Group Pitches Changes to Australia’s Regulatory System

Posted 19 January 2015 | By Michael Mezher 

Industry Group Pitches Changes to Australia’s Regulatory System

Medicines Australia, a trade group representing members of Australia’s pharmaceutical industry, is proposing a series of reforms to Australia’s regulatory system in the hopes of increasing the speed at which the Therapeutic Goods Administration (TGA) approves new medicines.

Independent Review

On 24 October 2014 the Australian government announced it would conduct an “independent review of the regulation of medicines and medical devices." The goal of the review will be to update the country’s regulatory system “to ensure Australians can access the latest treatments in a timely manner.”

The expert group will be led by Emeritus Professor Lloyd Sansom, who worked on Australia’s National Medicines Policy and was the former chair of the country’s Pharmaceutical Benefits Advisory Committee. Samson will be assisted by Will Delaat, who has extensive experience in the pharmaceutical industry, and Professor John Horvath, who was the country’s chief medical officer from 2003 to 2009.

Proposed Reforms

Despite TGA having consistent approval times for new drugs, Medicines Australia argues that the country often lags behind other developed nations for access to new medicines.

To address this lag, Medicines Australia is calling for reforms to TGA in four areas that it claims will bring the agency up to speed:

  1. "Optimizing work sharing activities with overseas regulatory agencies to increase efficiency. This includes the ability to adopt international decisions from trusted regulators where appropriate; and ensuring Australia upholds public health and safety through sovereign decision making.”
  2. "Creating multiple approval pathways including fast-tracked, priority registrations, breakthrough medicines and re-establishing flexibility."
  3. "Delivering on long-promised information technology capabilities including eCTD, communication portals between the TGA and sponsors, and a robust system of application tracking to ensure optimal operational efficiencies for both government and industry."
  4. "Eliminating unnecessary red tape in the registration system related to unnecessary data requirements for pre-submission and unwarranted duplication in Australian specific requirements in Module 1, and duplication in state and territory poisons legislation.”

Medicines Australia claims that giving TGA the ability to authorize products that have been approved by “trusted regulators” such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada will speed patient access to breakthrough therapies and reduce the agency’s workload.

A similar concept is in practice for medical devices in Australia, where foreign companies may import devices with CE Marking without receiving a market authorization from TGA. The Australian government is also considering allowing domestic manufacturers to register their products “using conformity assessment certifications from European notified bodies.”

The proposal also recommends creating new approval pathways similar to those in practice (or being piloted) by other regulatory authorities, such as accelerated and conditional approval.

Disagreement over Using Overseas Assessments

Not everyone agrees that Australia should use other regulators’ assessments to approve products.

Consumers Health Forum (CHF), an independent organization representing the Australian public on healthcare issues, believes that “off-loading … to ‘trusted overseas regulators’ … would dumb down Australia’s capacity to determine which new drugs should come to this country.” The group also argues that reliance on other regulators could hamper Australia’s ability to respond to adverse events.

What Happens Next?

The expert panel is expected to provide recommendations on Australia’s regulatory system for prescription and over-the-counter drugs by 31 March 2015. The Australian government will consider the recommendations as part of its efforts to reduce red tape throughout the nation.


Medicines Australia Position Paper

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