Medicinal Cannabis Industry Australia (MCIA) welcomes the Therapeutic Goods Administration (TGA) announcement of its final decision regarding down-scheduling of low-dose CBD, including the significant change to the maximum dose which has been increased to 150mg/day.
MCIA had recommended changes to the interim decision, and in particular the low daily dose, to ensure that there is an effective pathway for S3 CBD products. A report commissioned by MCIA supported a higher dose based on safety and efficacy, and hence, ability to meet the evidentiary requirements for the proposed registration pathway. MCIA is pleased that TGA’s further consideration of this information, along with other public submissions, and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at its November 2020 meeting, has led to a lifting of the daily dose.
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