Industry leaders have given a cautious welcome to the interim ruling to down schedule low-dose CBD, but significant doubts persist over how meaningful the decision will be for patients and manufacturers.
Concern will inevitably focus on the strength of efficacy data required by health authorities for a product to be registered on the Australian Register of Therapeutic Goods (ARTG) and therefore available for sale through pharmacies.
According to the Therapeutic Goods Administration (TGA), products must be “individually evaluated for quality, safety and effectiveness prior to inclusion on the ARTG”.
The eight-page interim ruling published yesterday also spelt out the need for solid data, emphasising that “only products that have been approved for a specific indication appropriate under a schedule 3 listing will be available without a prescription”.
With a paucity of clinical data for low-dose CBD, major questions remain whether over-the-counter product will really appear in Australian pharmacies.
Advisory committee “not persuaded”
Given the application to reschedule CBD had been initiated by the Department of Health, the TGA’s favourable interim decision had been widely expected.
But it was a determination that appeared to go against the views of the Advisory Committee on Medicines and Chemicals Scheduling, the majority of whom were “not persuaded… that cannabidiol meets the scheduling factors for schedule 3”.
Nevertheless, the TGA concluded that 98% pure CBD products could be made available for sale behind the counter from early next year, with a limit of 60mg per day and a maximum supply for 30 days.