The affected companies have pledged to resolve the inconsistencies, which were uncovered as part of routine surveillance conducted by the TGA.
The Therapeutic Goods Administration (TGA) has revealed that almost one quarter of the medicinal cannabis samples submitted to the organization for testing have failed to meet its TG093 regulation, which requires companies to declare their product's active ingredient content.
The TGA currently requires all products featuring finished plant material contain 80%-120% of the stated content, while oil finished products, tablet or capsule products must feature 90%-110%.
However, according to the TGA's recently released Laboratories Testing Report—which was conducted as part of routine surveillance on unregistered medicinal products provided to the Australian market under the SAS program—the affected products all returned up to 5% outside the upper or lower allowable limit of the stated active ingredient content.
It is encouraging that the TGA is starting to test the quality of the unregistered medicinal cannabis products being supplied in Australia. More widespread testing of products will hopefully lead to higher product quality and an industry in Australia that leads the world in terms of medicinal cannabis standards FreshLeaf Analytics Managing Director, Cassandra Hunt
As part of its testing blitz, the TGA targeted the top 25 medicinal cannabis products in the market by volume, finding only 17 met the stated content of active ingredients. Unfortunately, three were found to have less than the stated content, while two were identified as having more.
The remaining three were not supplied to the TGA—due to being commercially discontinued—and several prominent Australian cannabis companies were singled out as being responsible for the five failing products.
This forced the agency's hand, despite acknowledging that stability for plant-based medicines is a significant challenge, prompting them to label the inconsistencies as "concerning".
"In my experience, the TGA is more likely to test products either because a specific potential concern has been raised, or because they are considered higher risk," FreshLeaf Regulatory Specialist Tony Whittaker said.
"In this case, the supply of cannabis products has been increasing rapidly over recent years and have generally been made available under one of TGA's processes for unapproved goods such as the Special Access Scheme (SAS) or via an Authorised Prescriber (AP)."
"As SAS or AP cannabis products are unapproved, they have not been assessed by TGA for quality. I assume that significant supply of unapproved products represented a potentially higher risk and prompted TGA testing. The most commonly supplied products were likely selected as these would have the greatest potential to affect consumers."
According to FreshLeaf Analytics—which operates as a division of Southern Cannabis Holdings—the suppliers of the aforementioned products have been notified of their failure to meet the TGA's regulatory standards and were cautioned about the possible penalties.
Certain suppliers subsequently provided evidence to
demonstrate that their products had met the TGA's standards—at the time of
manufacturing—while others have stated that they will no longer supply the
affected medicine until the issue has been resolved.
"The testing recently carried out is a reminder to industry that TGA is able to test their products at any time while they are on the market, and that there can be serious consequences if they do not comply with regulations right up until the end of shelf life," Whittaker said.
"Analysis of cannabinoid-containing products is complex and I would hope that industry would respond by undertaking research in this area leading to further improvements in the ability to accurately measure active materials in cannabinoid products over their shelf life and better understanding the factors (such as manufacture, packaging materials or storage conditions) that affect stability of products over time."
"I look forward to sponsors, industry groups and laboratories continuing to work closely with the TGA to confirm that the analytical methods used ensure that cannabis products released to the Australian market continue to be of the highest possible quality."
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