New search function to identify new and updated Product Information
The TGA has introduced an online tool for searching new and recently updated Product Information (PI) documents that have been published on the TGA website in the previous 90 days.
This new functionality has primarily been implemented to help generic sponsors to meet their legal obligation to update their PIs if the innovator sponsor has made a safety update to the original PI. However, anyone interested in new or changed PI documents, including health professionals and patients, can use this functionality.
Previously, the process of identifying updated PIs was tedious and time-consuming, requiring generic sponsors to open the innovator sponsor's PI for each of their products on the market, compare with a previous version, and identify any changes.
The new search functionality will display each PI that has been changed or added and will provide a link to the document.
Searches can be made by specific time intervals showing all PIs that have been published in that period. The results can then be filtered by sponsor name, published date, active ingredient or trade name.
From January 2018, new PIs will also include a summary table of changes. All PIs will be updated to include this table over the following three years. Over time this will make the search function more valuable as PIs appearing in the search function will highlight the exact changes that have been made.
The new and recently updated Product Information search can be accessed under 'Public TGA Information' on the menu of the TGA Business Services website.
If you have any enquiries or issues with the new search functionality please contact us via phone on 1800 020 653 or email at email@example.com.