Even the most extensive research and testing before a medicine is first marketed cannot identify every possible side effect, also known as an 'adverse event'. When a medicine or vaccine is first registered and made available in Australia, information about its safety and efficacy is usually available only from clinical trials. Similarly, information from clinical trials can be used to support medicines extending their use into a significantly different disease, condition or patient group.

Clinical trials generally have strict inclusion criteria and relatively limited numbers of participants. This means it is common for new adverse events to be identified after new medicines are used more broadly in the population, or when existing medicines are used in a significantly different way. For example, some adverse events may be so rare that it takes thousands of people using the medicine for a long period before they can be identified. Many adverse events are minor, but some can be serious and even life-threatening.

Both health professionals and consumers are encouraged to report

The intent of the Black Triangle Scheme is to provide a simple means for practitioners and patients to identify certain types of new prescription medicines, or those being used in significantly different ways. The scheme encourages the reporting of adverse events associated with the use of these types of medicines. A similar Black Triangle Scheme currently operates throughout the member states of the European Union, including the UK.

The black triangle symbol, and accompanying text, will appear on Product Information (PI) and Consumer Medicines Information (CMI) of products included in the scheme. This will encourage both health professionals and consumers to report suspected adverse events. The black triangle will also appear in TGA-related material, such as Australian Public Assessment Reports for prescription medicines (AusPARs). Work is underway to include the black triangle in other sources of medicine information.

The Black Triangle does not denote that there are known safety problems, just that the TGA is encouraging adverse event reporting to help us build up the full picture of a medicine's safety profile.

Information for medicine sponsors

• Further information for sponsors with products included in the Black Triangle Scheme
  This includes instructions on what information to include in the PI and CMI of products included in the scheme.

Frequently asked questions

Which products will the Black Triangle Scheme apply to?

The Black Triangle Scheme will apply to certain prescription medicines only.

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).

When does the Black Triangle Scheme start operating?

The Black Triangle Scheme commenced in January 2018.

What changes will we see?

The black triangle symbol, and accompanying text, will appear at the top of the first page of the PI and CMI of products included in the scheme. The wording of the accompanying text is shown below.

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 at Reporting problems'(www.tga.gov.au/reporting-problems).

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. You can report side effects to your doctor, or by visiting Reporting problems' (www.tga.gov.au/reporting-problems).

The black triangle will also appear in TGA-related material, such as Australian Public Assessment Reports for prescription medicines (AusPARs). Work is underway to include the black triangle in other sources of medicine information. Some medicines information providers now display information about the black triangle scheme in their online resources.

How long will the symbol appear for?

For medicines included in the scheme, the black triangle will appear on the PI and CMI for five years, starting from the date of first supply.

For provisionally-registered medicines, the black triangle symbol will appear for a period of not less than five years. This will include the entire period of provisional registration, and may include a period of time following full registration. The duration following full registration will be determined during the evaluation of data to support full registration.

Inclusion in the scheme will automatically lapse at the end of five years, or the agreed period for provisionally-registered medicines. An application will not be required to remove the black triangle from the PI and CMI at the end of this period.

What should you report?

Adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a medicine and these should be reported, in particular serious adverse events and those not listed in the PI and CMI.

Every report counts. While an individual report may not be enough to determine whether a particular therapeutic good caused an adverse event, all reports help to build a picture of the safety profile of a product and assist with the TGA's safety monitoring program.

For more information on what to report, or to lodge a report yourself, visit Reporting adverse events.

How will the TGA use adverse event reports?

Postmarket monitoring of the safety of medicines and vaccines contributes to a better understanding of their possible adverse events when they are used outside the controlled conditions of clinical trials.

Each adverse event report the TGA receives is entered into a database, which is continually analysed by TGA staff to identify potential emerging problems for detailed investigation.

For more information or to lodge a report visit Reporting adverse events.

What medicines are included in the Black Triangle Scheme?

Medicines included in the Black Triangle Scheme can be found by searching the ARTG, using the advanced search option.