Black triangle scheme to promote adverse event reporting

The Therapeutic Goods Administration (TGA) is implementing a black triangle scheme.

Commencing January 2018, the scheme is designed to help health professionals and patients to identify certain types of new prescription medicines, and to encourage the reporting of adverse events associated with their use. A similar scheme currently operates throughout the member states of the European Union, including the United Kingdom.

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. 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.

Accompanying text for 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 www.tga.gov.au/reporting-problems.’

The black triangle symbol, and accompanying text, will appear on Product Information (PI) and Consumer Medicines Information (CMI) documents of newly registered prescription medicines (with the exception of biosimilar medicines, generic versions of already approved prescription medicines and seasonal influenza vaccines).

It will also be used for all provisionally registered medicines, including those with a provisionally approved indication.

Additionally, 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 black triangle will also appear in TGA related material, such as Australian Public Assessment Reports for prescription medicines (AusPARs). Future work will be conducted to include the black triangle in other sources of medicine information.

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.

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 more quickly. Adverse event reporting remains important for all products, including those without a black triangle.

For further information about the TGA’s Black Triangle Scheme visit www.tga.gov.au/black-triangle-scheme.

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