Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on November 08, 2017; which was revised on March 8, 2018 following amendments to the Therapeutic Goods Act 1989. The commencement date of the new PI form was January 01, 2018 with a transition period of three years ending December 31, 2020.
The key changes in the new PI format 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. The new format aligns more closely with the format of the European Summary of Product Characteristics (SmPC) and New Zealand Datasheet although there are some key differences in the presentation of information for the Australian PI, for example in sections 4.8 Adverse Effects and 6.7 Physicochemical Properties. The use of electronic bookmarks is strongly encouraged to facilitate navigation through the document. Important information is also provided for the required clean and annotated versions of the PI which must be submitted to support an application to revise content and reformat the PI.
Impact to the industry:
- All PIs accompanying Category 1 applications must be provided in the new format if they are submitted after January 01, 2018.
- Reformatted PIs should be submitted with any other application type related to that medicine, including minor variations, safety related requests, and applications to update medicine ingredient names.
The 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 should also need 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).
Reformatting PIs is an activity that could be done in advance with a view to having reformatted PIs available and ready to incorporate safety, quality or administrative changes as the opportunity arises for submission to the TGA under the appropriate submission category. Pharmaceutical companies may appreciate that the process of reformatting product information as quite time consuming and moreover bulk reformatting of existing PIs is an activity which is also amenable to outsourcing.