Worries Over Ambiguity & Imprisonment Prompt Australia to Revise Drug Shortages Proposals
As it presses on with plans to make the reporting of medicines shortages mandatory in Australia, the Therapeutics Goods Administration has taken on board industry’s concerns over how the new scheme will work.
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Legislation that would introduce the proposed mandatory scheme for reporting medicines shortages has come before the Australian parliament. Among other things it specifies which shortages would have a "critical impact" on patient health.
Filing for clinical trial activities in the electronic common technical document format via the Common Electronic Submission Gateway is expected to help sponsors send their information in a secure manner, with reduced transmission times and cost.