On October 12, 2017 the Therapeutic Goods Administration (TGA) added the Black Triangle Scheme (BTS) to their safety monitoring system. [1, 2]. “A similar Black Triangle Scheme currently operates throughout the member states of the European Union, including the UK.”
Five months before Provisional Registration which is added to the Therapeutics Goods Act in March 2018. All new and Provisionally Registered (PR) products fall under the BTS to help monitor for early safety signals. Product Inserts (PI) and Consumer Medicines Information (CMI) are indicated with a black triangle symbol [2, 3] which will appear for a period of not less than five years from start of PR. Sponsors are responsible to supply information for PI and CMI documents.
An adverse event is definded as “any unfavourable and unintended sign, symptom or disease associated with the use of ” the provisionally registered product and all “should be reported” by either consumers but most importantly health professionals, although the TGA don’t openly share this advice for COVID-19 vaccine products.
All 2021 COVID-19 vaccines were only Provisionally Registratered, which is distinctly different to Registered. [4]
United Kingdom’s drug regulator MHRA also has a Black Triangle Scheme, for continued monitoring of medicines, which appears to have been in place since June 1, 2009. [5] The European Medicines Agency (EMA) in 2017 was responsible for maintaining the list of black triangle products which included AstraZeneca, Moderna, BioNTech, Janssen COVID-19 vaccines.
It seems Black Triangle Scheme is not unique to Australia, but infact a global regulatory practice which the TGA adopted.