TGA Will Require Drug Shortage Reporting

Australia’s Therapeutic Goods Administration will require mandatory reporting of drug shortages beginning Jan. 1, 2019, after enabling legislation passed both houses of the Australian Parliament on Tuesday.

After the effective date, sponsors must report all medicine shortages they experience and the agency will publish information about current and anticipated shortages through its Medicines Shortages Information Initiative webpage. Shortages deemed to have a low or medium impact may be published if sponsors agree.

The agency said drug shortages have become an increasing problem in Australia, as the current voluntary scheme for reporting shortages has proven ineffective. “Many shortages of critical patient impact are not currently reported…which means valuable information cannot be shared with consumers and health professionals and causes delays to the effective management of medicine shortages.”