AusPAR content, January 2018: registration timelines

TGA

3 November 2017 - The content of AusPARs will be updated to provide increased transparency of TGA's evaluation process through the inclusion of a registration timeline in each AusPAR. 

The registration timeline will be included in AusPARs published after 1 January 2018.

The registration timeline outlines the designation (if applicable) and major evaluation steps through which the sponsor's application passed on the way to TGA's registration decision. This timeline includes dates outlining TGA's evaluation commencement and completion, risk-benefit assessment, and the advisory committee meeting (if applicable). The registration timeline also includes the number of TGA working days from the acceptance of the submission to TGA's decision.

These dates represent a more comprehensive list of evaluation events than previously published in AusPARs, which included only the registration decision date and, for approved submissions, the date of entry onto the ARTG.

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Michael Wonder

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Michael Wonder