Shortages of potentially life-saving medicines must be reported to the drug watchdog under a proposed overhaul of medicine reporting laws.
Health Minister Greg Hunt says some situations, like an EpiPen shortage in April, could put patient lives at risk.
A voluntary scheme has been in place since 2014 but it has been ineffective, he says.
"A significant number of medicine shortages of critical patient impact have not been reported to the TGA, or not reported in a timely manner," he said.
The new mandatory scheme would require critical drug shortages to be reported within two days and non-critical shortages within 10 days.
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Decisions to discontinue products would also need to be reported up to a year ahead of time.
