Evolving Australia’s World Class Regulatory System for the Future

Medicines Australia has put forward its recommendations for consideration in its submission to the Therapeutic Goods Administration’s (TGA) Expert Review of Medicines and Medical Devices Regulation.

CEO of Medicines Australia, Tim James, said targeted reform is required to further develop the Australian regulatory system, ensuring that it’s adaptive and responsive to changes in business and technology.

“It’s important that we can identify ways to restructure Australia’s regulatory framework so that it is fit-for-purpose and globally competitive,” Mr James said.

“This is why Medicines Australia has put forwarded recommendations on optimising work sharing activities with overseas regulatory agencies, creating multiple approval pathways, delivering on long-promised information technology capabilities, and eliminating unnecessary red tape in the registration system.

“Regulation in Australia needs to be retained through an efficient system driven by innovative resources which deliver results that keep pace with medical developments. Updated and harmonised information technology will be critical to achieving success.

“Any changes which are made to the system must firstly focus on ensuring the internationally recognised standard for regulation in Australia is retained.

“We know that Australia must retain its capacity to undertake independent assessments of therapeutic goods, with this responsibility remaining with the Commonwealth of Australia.

“We also know that adoption of expedited decisions from trusted overseas regulators where appropriate will significantly reduce duplication of regulatory effort.

“We believe that targeted reform is required to evolve the Australian regulatory system to better reflect the global environment.

“If our recommendations are recognised and adopted by the Australia Government, it will simplify regulatory processes, harness international efficiencies, and ensure the internationally recognised standard for regulation in Australia meets community expectations and patient needs.”


Contact Person:

Alexia Vlahos
Phone: (02) 6122 8503