Importers will have to specify the length of drug shortages and the regulator will be able to import clinically important discontinued medicines.
To tackle drug shortages across Australia, the TGA has mandated that sponsors provide up-to-date information on the length of drug shortage periods, starting this month.
They will also now be able to approve the import of overseas substitutes for medicines that are no longer registered in Australia.
The updates follow changes to the Therapeutic Goods Act 1989 that were released in March, based on the outcome of a consultation on improving the reliability of Australia’s supply chain for important drugs.
As of 22 September – after a six-month transition to allow suppliers to rejig their internal reporting processes – companies supplying drugs in short supply in Australia will be required to specify the period of shortage to the TGA.
Any changes to the length of the shortage must be reported within two working days if the shortage is critical and within 10 working days for all other shortages.
The TGA hopes that “upcoming changes to reporting requirements will assist health professionals and patients in managing shortages by keeping our Medicine Shortage Reports Database as up-to-date as possible”.
The recent updates also allow the TGA to temporarily approve the import and supply of drugs from overseas that can act as a substitute for drugs that are no longer registered on the Australian Register of Therapeutic Goods.
The TGA hopes that this will “minimise the impact of medicine discontinuation by providing continued patient access”.
Previously, patients with a clinical need for drugs that had been suspended or discontinued from the ARTG were unable to import overseas substitutes. Only substitutes for drugs on the ARTG could be approved for temporary import.
“These Act changes have been introduced to help us alleviate the effects of medicine shortages on patients and provide up-to-date information to patients and health professionals,” the TGA said.