The Hon Catherine King, Parliamentary Secretary for Health and Ageing
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THE HON CATHERINE KING

Parliamentary Secretary for Health and Ageing

Another Milestone For Prescription Medicine Reforms

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The Therapeutic Goods Administration has commenced a streamlined submission process for selected prescription medicines applications in Australia.

PDF printable version of Another Milestone For Prescription Medicine Reforms (PDF 26 KB)

1 November 2010

The Parliamentary Secretary for Health and Ageing, Catherine King, has announced a key milestone in reforming the regulation of prescription medicines in Australia.

“After considerable planning and consultation with stakeholders, the Therapeutic Goods Administration will today commence operating a streamlined submission process for selected prescription medicines applications in Australia,” Ms King said.

“The TGA is committed to ensuring timely access to safe, effective and quality medicines for consumers. The new process will significantly improve the quality of submissions and predictability of timelines for registration of prescription medicines in Australia.”
While maintaining the scientific rigour of TGA’s evaluation process, efficiencies will be achieved by:

  • early notification of the details of applications, 3 months in advance, to allow the TGA to undertake effective resource planning
  • streamlined processes for evaluation of applications, with all requisite data provided at the time the application is lodged.
“The first 12 months is a transition period to enable the TGA to work with applicants to fine-tune the new business processes, with full implementation targeted for 1 November 2011.”
The achievement of this milestone builds on the prescription medicine reforms successfully implemented by the TGA in partnership with industry to:
  • provide enhanced access to prescription medicine information through a single trusted source of Product Information (PI) and Consumer Medicine Information (CMI) documents on the TGA website
  • increase the transparency of the regulatory process via the public release of Australian Public Assessment Record (AusPAR) for new products or major variations to existing products.
This initiative is one part of the modernisation of regulatory arrangements that is currently under way at the TGA.
Ms King said: “These reforms will increase the transparency and responsiveness of the TGA’s activities, in line with the Australian Government’s agenda to reduce the regulatory burden placed on Australian business.”

More information on the project is available on the TGA website (www.tga.gov.au).

For more information, please contact the Parliamentary Secretary's Office on (02) 6277 4230

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