How long will it be before Australians have access to over-the-counter medical cannabis? Separate myths from truth

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It can take at least 12 months for over-the-counter CBD drugs to be purchased in Australia.

Since last week, Australian patients have been officially allowed to buy low-dose cannabidiol (CBD) from a pharmacist without a prescription.

The Australian Medicines Agency, the Therapeutic Goods Administration (TGA), gave the go-ahead on February 1 and increased the daily dose limit from 60 mg to 150 mg per day compared to its interim decision last year.

While this is expected to have positive effects on the lives of many patients, myths circulate about this development that need clarification.

According to the Medical Cannabis Research Collaboration (MCRC), the research division of Cannvalate, there is a grave misconception that products are currently available for purchase – but in reality, consumers could wait a year or more.

Reclassification of CBD Medicines

Small Caps first reported on the TGA’s preliminary decision to downplay certain CBD products from Appendix 4 (prescription drugs) to Appendix 3 (Pharmaceutical Only Pharmaceuticals) of the Poisons Standard in September.

This means companies can apply to register their applicable products to be available through a pharmacist without the need for a prescription.

In December, the TGA finalized its decision and increased the dose limit to a maximum of 150 mg per day after further examination of the safety information, public statements on the interim decision and advice from advisory committees. The plan change came into effect on February 1st.

Since then, rumors have been circulating that CBD products are expected to be available over the counter right away, or at least sometime in 2021.

However, according to Julian Azzopardi, Cannvalate’s Chief Growth Officer, it will “not be easy” to meet the TGA’s criteria for Schedule 3 over-the-counter status.

“Most products currently lack the clinical data necessary to meet TGA’s stringent safety, efficacy and quality standards,” he told Small Caps.

“Registration of a CBD product in the TGA registry is not automatic and requires meaningful clinical data, including phase I, II and III clinical trials. Once the data has been collected and the dossier has been submitted to the TGA, there is a schedule for the TGA assessment of approximately six months. “

“You could expect CBD to be available in your pharmacies by 2022,” said Azzopardi.

Product registration can be a lengthy process

Typically, the schedule for conducting clinical research to register a product with a global regulatory agency is a lengthy process that can take several years.

The Australian New Zealand Clinical Trials Registry (ANZCTR), an online clinical trial registry, shows that there are currently very few studies conducted to study cannabinoids that could relate to a Schedule 3 registration program.

The expectation of a regulator to register a product is that the safety, quality and effectiveness goals will be achieved.

Safety is demonstrated in part by conducting toxicological studies on two animal species. However, the TGA has already classified low-dose CBD as a safe ingredient and has therefore downgraded it from prescription to over-the-counter products.

Efficacy goals must be achieved using the manufacturer’s final dosage form and the correct concentration. Evidence that the CBD product is performing well for a specific medical indication is critical. For example, a CBD pain reliever must lower a patient’s visual analog value (a measure of pain intensity most commonly used in pain research) by 33%.

The concentration of 150 mg was only confirmed by the TGA in mid-December 2020, which means that the manufacturers could only complete their clinical study program until this final decision.

To ensure that the quality of the product meets the appropriate standards and is consistent, a very detailed Chemistry, Manufacturing and Controls (CMC) dossier is mandatory.

However, a partially literature-based submission may be feasible for some of the required evidence, which would allow for an expedited path.

“After the TGA provides clarity on the level of clinical justification for registering an S3 product, it will take 12 months or more for a company to meet the TGA S3 registration criteria,” said Dr. Sud Agarwal, Cannvalate’s chief executive officer, told small caps.

“The Australian media and some ASX listed companies may have inadvertently misled the public into believing that the public could now go to a pharmacy and buy CBD without a prescription,” he said.

Although Mr. Azzopardi, who heads Cannvalate’s Medical Cannabis Research Center, has admitted that political pressure could be a motivation for the TGA to speed up its usual approval period – in which case it could change projections.

“But right now 12 months or more is accurate,” he said.

Preparation for registration

Mr Azzopardi said that the MCRC’s approach to registering a Schedule 3 product involves preparing a full submission to the TGA detailing the proposed route and requesting validation.

The path will cover the proposed methods for demonstrating the required safety, effectiveness and quality criteria.

“We are currently assisting four companies with registering one or more Schedule 3 CBD products and look forward to debunking the new regulations if any stage is exceeded,” he said.

According to the Oceania Cannabis Report, produced by the London-based advisory group Prohibition Partners, the Australian medical cannabis market is estimated at up to $ 1.3 billion by 2028.

Mr Azzopardi said the MCRC had received several inquiries from local and international organizations in hopes of securing market share in over-the-counter CBD sales in Australia.

“We have received approval from the Human Research Ethics Committee (HREC) to initiate clinical trials for two sponsors developing S3 CBD products. Further programs are expected to be approved soon. This is a very exciting place for us given our specialization in medical cannabis, ”he said.

Cannvalate currently serves approximately 40-50% of medical cannabis patients in Australia through its prescription network.