TGA Approves New product information PI Form for generic & biosimilar products

Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.

The rationale behind the new update is to ensure that critical clinical information is more accessible within the document. In addition, the new format has been developed to align with the formatting requirements of other international regulators, specifically the New Zealand medicines regulator Medsafe, and the European Medicines Agency (EMA).

The key changes in the new PI form include reordering the content to bring critical clinical information together to the front of the document. The changes also include updating headings and sub-headings that align with internationally-used standards. have been added to facilitate the harmonization of formats with those used in New Zealand and Europe.

The product information (PI) of every product that is marketed in Australia needs to be reformatted as per the new template during the transition period. The PI of generic and biosimilar products also needs to be reformatted. This can be done prior to the innovator PI as the content of the PI will not be changed as part of the reformatting process.

If the PI is being reformatted without any content changes then an annotated copy is not required. Only the clean copies of currently approved PI and the reformatted PI require submission. If the PI is being reformatted as part of an application, to make content changes to the PI, then the following documents should be submitted:

  • Clean copy (old format, no changes)
  • Clean copy (new format, no changes)
  • Annotated copy (new format, tracked/annotated changes) and
  • Clean copy (new format, with proposed changes).

Early adoption is a key to early success. Decode and understand more about TGA’s new Product Information form, and align with 2 years transition timelines for end-to-end compliance by 31st December 2020. Get more insights on the new PI form.