The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients. The new form will be implemented over a 3-year transition period commencing from 1 January 2018.
The new format is mandatory for all new and changed PIs included in applications submitted after 1 January 2018. It is strongly recommended that reformatted PIs be submitted for Category 1 applications currently under review. All PIs for marketed products will need to be converted to the new format by 31 December 2020.
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 main change in the form is reordering of the content to increase the prominence of critical clinical information such as indications, dosage and method of administration, contraindications and precautions. These are now located towards the beginning of the document to further enhance the safe and effective use of medicines.
PIs must be reformatted as part of any application affecting their content but reformatted PIs can also be submitted with other application types which do not include changes to the PI without incurring an additional fee.
The task of reformatting existing PIs may be time consuming initially. The benefits of the new format in the longer term will be realised by the reduction the regulatory burden associated with maintaining Australia texts in alignment with the European SmPC and New Zealand Datasheet.
Sponsors who have undertaken the exercise of reformatting data sheets for New Zealand will appreciate that the process of reformatting product information is quite time consuming, but becomes more efficient with greater familiarisation and experience with the template. 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. Bulk reformatting of existing PIs is an activity which is also amenable to outsourcing.
The TGA have provided Frequently asked questions to support the creation of new PIs and reformat of existing PIs. Templates are also available which include the required heading and subheadings. 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.
For guidance or assistance in reformatting your PIs contact our expert Regulatory Services team on +61 3 9251 0777.