News

We will be initiating targeted compliance reviews of selected listed medicines that are required to display a warning statement

The Prescription Medicines in Pregnancy database has now been updated to include the following new entries:

Listed medicine compliance review reports database March 2025 update

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The updated plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies.

Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.