By now, we should all be very familiar with the new Form for providing Product Information (PI) for Australia Each time you make a change to a PI, be it safety-related or otherwise, you’re required to provide the updated PI to TGA in the new format.
The looming deadline for marketed product PIs to be in the new format is 31 December 2020 . As we are already in mid-March, that’s not very far away. However, more than two thirds of the way through the transition period, a review of a random sample of PIs indicates that approximately 45% of products on the ARTG are still in the old format!
TGA are trying to help Sponsors meet the deadline. To encourage submissions, they have introduced a fee exemption, until the end of the year, for applications where the only change is to reformat the PI and no other editorial changes are made.
What can you do to make the process easier?
- Establishing a robust template is extremely important. Although the TGA have provided a bookmarked template, it can be significantly upgraded to include mandatory and standard TGA statements, as well as standardised company preferred text and instructions for the reformatting party.
- Documenting PI reformatting decisions and implementing them consistently across the organisation is also key to improving efficiency. Reformatting is not an exact science – variability abounds.
- How many PIs does my team have still to reformat?
- How many hours are still to be invested?
- Will it be possible to meet the deadline at the current rate of progress?
- Could my highly skilled team be putting their time to better use?
If you need support to meet the 31 December 2020 deadline, we’re here to help.
Our team of regulatory experts and medical writers can efficiently manage your PI reformatting as an outsourced project, relieving the burden on you and your team. Take the stress out of your PI reformatting project today by contacting us.