Emerald Clinics Ltd (ASX:EMD) welcomes the interim decision from Australia’s Therapeutic Goods Administration (TGA) that recommends low dose cannabidiol, or CBD, become a Schedule 3 medicine on the Australian Register of Therapeutic Goods (ARTG).
The interim ruling outlined the process for low dose CBD to be registered as a Schedule 3 medicine at the 60mg/day limit.
Registration of low dose CBD would require a full submission to the TGA and high-quality clinical evidence to support safety and effectiveness.
The TGA interim decision could allow patients to purchase low dose CBD as a pharmacist only or over-the-counter medication for specific indications.
Advertising to consumers would not be permitted and higher doses of CBD and other cannabinoid medicines would still require a prescription from a medical practitioner.
“Encouraged by meaningful commitment”
Emerald Clinics' chief executive officer Dr Michael Winlo said: “Regulators play an important role ensuring medicines are safe and effective before they are available to patients which is why they require independent and high-quality clinical evidence to support their recommendations.
“Emerald exists to generate product-specific real-world evidence packages and insights that can support regulators, like the TGA and others involved in these decisions around the globe, together with developers of CBD and other new treatments.
“We are encouraged by this meaningful commitment to bring evidence-based, innovative therapies to patients.”
The TGA will undertake a second consultation period with a closing deadline of October 13 and expects to make a final decision on February 1.