On December 20, 2017 the Australian TGA announced that it would make use of assessments from comparable overseas regulators (CORs) and international assessment bodies, where possible, in the regulation of medicines, to reduce the duplication of effort where an assessment has already been conducted outside Australia.
In response to the Medicines and Medical Devices Review (MMDR), which led to the March 20,2018, Provisional Registration reglatory pathway, the TGA also reformed the way it collaborated with comparable overseas regulators, another way of seemingly speeding up drug approvals.
CORs are deemed to be Canada, Japan, Singapore, Switzerland, United Kingdom, United States and European Union- in time most of these will come together to form the ACCESS consortium [5] , and form bodies like the Access COVID-19 Vaccine Working Group, working with WHO and the International Coalition of Medicines Regulatory Authorities (ICMRA) to achieve global regulatory alignment. [1, 2, 3, 4, 5]
“In December 2020, the Access Consortium released information regarding the regulatory evidence requirements for COVID-19 vaccine authorisations and considerations for post-market pharmacovigilance which built on the Consortium’s pledge to work together to counter the COVID-19 global pandemic.”
Then as early as March 2021, only 2 months after the COVID-19 vaccines rolled out, the Access Consortium released “guidance clarifying the information required by medicine regulators to approve any modifications to authorised COVID-19 vaccines should virus mutations make them less effective at preventing the disease.” [1]