September 13, 2021
TGA’s Black Triangle Scheme – A Complete Perspective

Health Authorities worldwide are initiating various programs to strengthen Adverse Drug Events (ADE) reporting of new prescribed medicines every day. An Adverse Drug Event (ADE) can be defined as any unfavorable and unintended sign, symptom, or disease associated with the use of a medicine.  The safety and efficacy of new prescribed medicine is usually decided based on clinical trials. And as the clinical trials are subjected to a restricted number of participants, it is highly possible for a new side effect - ADE - to be identified when a larger population uses these drugs. While some ADEs may be minor, some may be fatal, and hence it is crucial to report them.

The Black Triangle Scheme is one such initiative by the Therapeutic Goods Administration (TGA), Australia, which provides a simple means for practitioners and patients to identify certain types of new prescription medicines or those being used in significantly different ways and improve the currently-low ADEs reporting.

Under this program, a list of medicines is provided, which has a black triangle inscribed on them, indicating that they are subjected to additional monitoring. The black triangle symbol and accompanying text will appear on the Product Information (PI) and the Consumer Medicines Information (CMI) of products included in the scheme.

The Black Triangle Scheme commenced in January 2018 to encourage the health professionals and the consumers to report any possible adverse reactions observed with the medicines.

Before the scheme’s commencement, TGA conducted time series analysis with segmented regression to analyze the quantity of ADE reports pre and post the scheme for a year. The analysis showed an increase of 0.41 reports per medicine (95%CI, 0.02-0.80, p = 0.039) post the scheme.

The black triangle scheme applies to certain prescribed medicines only and does not mean that the medicine is unsafe. Based on the criteria given by the TGA, a sponsor should mention in the application that the drug is to be added in the scheme.

This scheme facilitates the TGA in post-market monitoring of the safety and efficacy of the drugs circulating in the Australian market. The ADE reports help the TGA analyze the performance and characteristics of a new drug and identify a potential emerging threat.

It is necessary for Pharma manufacturers to be fully aware of the TGA regulations to apply for inclusion in the scheme. To know more about the functioning of the Australian Health Authority and drug registrations, reach out to an expert for Regulatory consultations and solutions; stay informed and stay compliant.