Regulatory Focus™ > News Articles > Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

Australia Proposes Changes to How Sponsors Amend Approved Prescription Applications

Posted 12 June 2012 | By Alexander Gaffney

Australia's Therapeutic Goods Administration (TGA) announced on 12 June the impending release of proposed changes to how sponsors of registered prescription medications can make "minor variations" to the medicine's entry in the Australian Register of Therapeutic Goods (ARTG).

TGA said the changes typically fall under one of four categories: corrections to the entry, a safety-related changes, "self-assessable" quality-related changes or Category 3 quality-level changes. The agency said in a statement it hopes the proposed change will decrease the time necessary to make changes, increase regulatory certainty and "improve the transparency of TGA processes."

A consultation on how to implement the changes is planned for August and September of 2012, with final implementation occurring by November 2012.


Read more:

TGA - Process review: minor variations to prescription medicines - for sponsors


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