TGA to introduce a Black Triangle Scheme from 2018

The Therapeutic Goods Administration (TGA) at the Department of Health for the Australian Government has announced the introduction from January 2018 of their own Black Triangle Scheme, similar to the scheme that is already in place throughout the European Union (EU). The Black Triangle Scheme is useful to alert healthcare professionals and patients to those medicines for which the reporting of all adverse events is considered most important.

The Black Triangle Scheme requires that this:▼  -inverted black, triangle symbol is prominently placed at the top of the first page of the Product Information (PI) and Consumer Medicines Information (CMI) of all products included in the scheme.

The Black Triangle Scheme will not apply to all medicines; the TGA has outlined the following:

‘Newly registered prescription medicines will be included in the scheme, except for biosimilar medicines, generic versions of already-approved prescription medicines and seasonal influenza vaccines. Seasonal influenza vaccines will not be included within the scheme as the AusVaxSafety program funded by the Commonwealth Department of Health provides additional monitoring of the safety of these vaccines.

All provisionally registered medicines will be included within the Black Triangle Scheme, including those with a provisionally approved indication. In addition, other medicines may be included following approval of an extension of indication that is for:

  • a significantly different condition; and/or
  • use in a significantly different patient population.

The decision to include these medicines will take into consideration whether there is international evidence to indicate that the safety profile for the new indication is consistent with the current indication(s).’

Inclusion in the scheme for registered medicines will be for 5 years after the first date of supply, and will automatically lapse; for provisionally-registered medicines the duration will be the whole period prior to registration and possibly an agreed period afterwards .The black triangle symbol must be accompanied by the following text:

For the PI: ‘This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information in Australia. Healthcare professionals are asked to report any suspected adverse events.’

For the CMI: ‘This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. You can help by reporting any side effects you may get.’

The Black Triangle Scheme aims to encourage increased reporting of all adverse events for medicines where a full safety profile is not yet established and for which a less common adverse event might be identified after a marketing authorisation is granted and a wider patient population is exposed. Therefore, the reporting of serious adverse events and those not listed in the PI and CMI. Is particularly important.

The full article announcing the scheme can be found by clicking here.