On March 29, 2018 the Australian government added a Provisional Registration (PR) amendment  to the Therapeutic Goods Act (1989), of which the TGA Secretary now has overriding power to send a product application through the registration process with only preliminary clinical data. [3, 15]

This decision was publicised on June 26, 2017 as a “Priority review pathway for the registration of novel prescription medicines for Australian patients….[and] will involve faster assessment of vital and life-saving prescription medicines“.  With specific eligibility criteria, of serious or life-threatening condition, where no existing alternative product is available.

The intent of this new registration category was explained in parliament in September 14, 2017 by the Health Minister, Mr Greg Hunt, as being intended as an avenue to provide “medicine” to those people with “significant unmet clinical needs for serious conditions”. [8, 9]

The process started October 24, 2014 with the announcement of the MMDR panel of 3 experts to review and report  on the regulatory framework of therapeutic goods. [4, 5, 6, 7]  The panel recommended a provisional pathway. [13, 14]

The government responded in 2016, noting the “international trends towards allowing earlier access to medicines” especially looking to fast-track “novel and life–saving medicines”, with a seeming emphasis on cancer drugs. [10]

  • Provisional registrations are of a limited duration (max 2 years) and require the sponsor to supply ongoing clinical data to support their product.
  • All PR products are part of the Black Triangle Scheme where healthcare professionals or consumers should report to the TGA all and any “any unfavourable and unintended sign, symptom or disease” following the use of the product “to help us build up the full picture of a medicine’s safety profile.”  It’s not the doctor’s job to determine if a unintended consequence is related or not to the medicine.
  • “For provisionally-registered medicines, the black triangle symbol will appear for a period of not less than five years.””
  • Such “registrations” are added to the Australian Register of Therapeutic Goods (ARTG), but they are not classed as fully registered, they are still under assessment and may never receive full registration status.

Between 1 April 2018 until 22 June 2021 there has been [12] Provisional Registrations of which 2 are COVID-19 vaccines [1, 2] and 1 is remdesivir.