On January 2, 2018 the TGA announced their criteria for working on opportunities for enhanced international collaboration in the regulation of prescription medicines with their Comparable Overseas Regulators (CORs) on prescription medicines criteria for jointly assessing dossier submissions.  [1, 2]

  • “In response to the Medicines and Medical Devices Review (MMDR) we are reforming the way we collaborate with comparable overseas regulators” – and “implementing a formal process for work-sharing with CORs on prescription medicines applications.”
  • Under this process, multiple regulators would be able to work simultaneously on different parts of a dossier submitted for evaluation in each jurisdiction. A joint evaluation report would then be provided to each agency to allow independent decision-making.”
  • They start out by sharing the work load on reassessing generic medicines [3]

Regulators around the world in 2020 did not review COVID-19 vaccine information separately.  They shared the workload!