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Review on the safety of low dose cannabidiol

Version 1.0, April 2020

24 April 2020

The TGA sought to undertake a safety review of cannabidiol (CBD) at lower doses, noting that there were only limited published studies available. This review commenced in late 2019 and concluded in April 2020.

The aim of this review was to assess the current clinical literature to investigate the safety of low doses of CBD and what low dose ranges are used in research studies. It also sought to determine if the safety profile and characteristics of the low dose CBD lends itself to consideration for down scheduling.

The review focused on safety and therefore did not look at the efficacy of low dose CBD in the management of specific conditions. The review also does not make specific recommendations about possible indications for low dose products

Background information

On 14 November 2019, the Senate referred an inquiry into the current barriers to patient access to medicinal cannabis in Australia to the Senate Community Affairs References Committee for inquiry and report by 26 March 2020.

In January 2020, the Department of Health made a submission to this Inquiry. This submission included that the TGA was currently undertaking a safety review of CBD at lower doses, noting that there were only limited published studies. In the submission, the Department also noted that depending on the outcome of the review that scheduling status of low dose CBD products would be considered.

The Inquiry recommended that the Therapeutic Goods Administration (TGA) conduct a public consultation on the future scheduling of cannabidiol and refer this to the Advisory Committee on Medicines Scheduling (Recommendations 12 & 13).

Next steps

Now that this safety review has been completed, the Delegate of the Secretary has proposed to down-schedule low dose CBD. Consultation on this proposal is now open for public comment ahead of consideration by the joint meeting of the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling. The consultation closes on 22 May 2020.

Following Committee consideration at their June 2020 meeting, the Delegate will make an interim decision and a second public consultation period will follow before the Delegate makes the final decision. More information is available at Scheduling committees meeting dates and decisions timeframes.

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