Update - Regulation reforms approved
The Therapeutic Goods Regulations 1990 have been amended to support improved Consumer Medicine Information (CMI).
The reforms establish new templates for prescription medicines and non-prescription medicines, which outline minimum requirements and exemptions to requirements where applicable.
For submissions made from 1 January 2021 that result in a new register entry (e.g. new chemical entity, extension of indication, major variation), the CMI must be produced using the new template. All previously registered medicines will be required to adopt the new format by 30 December 2025. While the reforms include a significant transition period, the TGA will be working with industry stakeholders to encourage sponsors to adopt the new format earlier for the benefit of consumers.
The updated regulations maintain the previously established general requirements that CMI documents must be:
- written in English
- clearly legible
- written in language that will be easily understood by consumers
- consistent with Product Information about the product.
The changes require that CMI must also set out all of the information required by the TGA Consumer Medicine Information (Prescription Medicine) Template (for prescription medicines, as described in Schedule 12 of the regulations) or the TGA Consumer Medicine Information (Non-prescription Medicine) Template (for non-prescription medicines, as described in Schedule 13).
The templates are provided below in editable Word format, along with additional guidance to support implementation.
Additionally, below are links to two guidance documents. The 'Improved CMI guide' provides general information and guidance about key communication principles and tips and tricks for using the template (please note that it pre-dates development of the template for non-prescription medicines, but that the information provided will assist with creating CMI for any product). The Using the TGA CMI template: Guidance for sponsors document provides more specific information relating to the updated Regulations, including differences in requirements between prescription and non-prescription products.
- TGA Consumer Medicine Information (Prescription Medicine) Template (docx,42kb)
- TGA Consumer Medicine Information (Non-prescription Medicine) Template (docx,37kb)
- Using the TGA CMI template - Guidance for sponsors
- Consumer Medicine Information (CMI) - How to use the improved CMI template
- Creating the CMI summary page - Guidance for sponsors
Improved Consumer Medicine Information template
9 September 2019
The TGA, in consultation with consumer, health professional and pharmaceutical industry representatives, has developed an improved template for Consumer Medicine Information (CMI).
CMIs are intended to provide consumers reliable and easy-to-understand information about the safe and effective use of prescription medicines and certain over-the-counter medicines.
The new template has been developed in response to concerns raised about the complexity and readability of CMIs. It is shorter, better laid-out and features a one-page summary that provides people with the most critical information about their medicine at a glance.
Implementation and transition period
There are several thousand products marketed in Australia that have CMIs. As such it may be some time before consumers begin seeing CMI in the new format, as pharmaceutical companies will need reasonable time to implement the changes across their products.
The Therapeutic Goods Regulations 1990 have been updated to clarify and standardise CMI requirements. In the meantime, we will continue to consult with pharmaceutical companies regarding implementation details, including how the template is to be used for prescription and over-the-counter medicines, issues relating to when CMI is provided in or attached to the packaging, and an appropriate transition period.
The TGA will also continue to develop guidance and other resources, including examples of products in the new template and a webinar, to support companies to use the template.
It is important to note that usability of CMI will continue to heavily rely on the quality of the content produced by the pharmaceutical companies who are responsible for these products.
Development and user testing
In January 2019, the Minister for Health, the Hon Greg Hunt MP, wrote to pharmaceutical company and health professional groups about the issues identified with the current format of CMI. He requested that a group, coordinated by the TGA, be convened to develop an improved template.
The first step was a TGA-facilitated stakeholder workshop held on 1 February.
Participants at this workshop drew on the findings of previous research and user-testing undertaken by the University of Sydney and the Electronic Distribution Working Group (EDWG) - an independent committee that promotes and facilitates the electronic distribution of CMIs to health professionals and their patients.
The workshop agreed on a revised format based on a template proposed by the University of Sydney's Investigating Consumer Medicine Information research project, with some changes based on a design tested by EDWG. This template was subjected to independent user testing and received excellent feedback from participants (see below for the evaluation report).
The template and findings were presented to a final stakeholder workshop on 6 June, where they received unanimous support from doctor, pharmacist, industry and consumer representatives.
Additional targeted consultation has since been undertaken and the TGA will continue to work closely with stakeholders regarding implementation.
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