Australia Proposes Plan to Speed Drug Approvals

The Australian government is planning to reform its drug approval pathways with proposals that include provisional marketing authorization and a reliance on assessments from foreign regulators.

The proposed changes would take effect over the course of about three years and would bring products to market faster through two new pathways that would grant approvals based on an evaluation report from comparable foreign regulators and preliminary clinical evidence.

The government intends to further define the criteria for these approval frameworks, but says that drugs offered preliminary approval would have to provide post-marketing evidence for full marketing authorization.