The Therapeutic Goods Administration (TGA) Australia has released information for sponsors regarding the Black Triangle Scheme. Prescription medicines are included in the scheme if they meet one or more of the following criteria:
- The product is newly registered (type A applications, excluding biosimilar medicines and seasonal influenza vaccines).
- The product is provisionally registered, or has a provisionally registered indication.
- The indications of the product have changed to include use in a significantly different population, for example, paediatric use and/or disease or condition such as a change from an oncology indication to a non-oncology indication.
The TGA states that the eligibility of a product for inclusion in the scheme will be considered in the Risk Management Plan (RMP) evaluation. A fully-registered product that meets the eligibility criteria will be included in the Scheme for 5 years.
All products that are included in the Black Triangle Scheme must have the black triangle symbol and required text included in the Product Information (PI) and Consumer Medicine Information (CMI). The PI should be presented in the required format.
To read more about the Black Triangle Scheme, please click here.