Australian Therapeutic Goods Administration (TGA) Reduces Timeframe for Publishing Adverse Event Reports

On 19 August 2021 the TGA announced a reduced timeframe for publishing adverse event reports.

With strong public interest in adverse event reports relating to COVID-19 vaccinations, and improvements in our IT systems, the TGA is making reports for medicines and vaccines publicly available more quickly.

The changes will reduce the time between adverse event reports being accepted into our database and published on the Database of Adverse Event Notifications - medicines (DAEN) from 90 days to 14 days.

These changes align with the TGA's Digital Transformation project which over the coming couple of years will digitize, transform and modernize our business systems and infrastructure and allow for greater transparency. The shorter time period for making adverse event reports available to the public is also consistent with other international regulators.

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