Untangling GMP in Australia’s Medical Cannabis Landscape
There are plenty of acronyms to wrap your head around in the cannabis world and GMP or Good Manufacturing Practice is one that is at the forefront of the industry. Around the globe there’s been a shift towards extract-based products over raw flower for medical cannabis consumption, promoting the acceleration and demand for pharmaceutical grade, GMP products.
Australia has initiated its cannabis industry with a focus on high-quality pharmaceutical products, ebbing away at its association with the stigmatised and risky method of smoking. Coming to light is a veritable rainbow of other methods for ingesting cannabis medicines, from sublingual wafers to transdermal patches, the options are seemingly endless. In this, consumers and regulators are demanding the highest quality products, in line with what is expected from GP prescribed pharmaceuticals.
Initiation of GMP began at the beginning of the 20th century in the USA. By the mid-1960s after several high-profile cases involving deaths, deformities and contamination from pharmaceutical products, the World Health Organisation drafted their first text on GMP regulations. In the years since, detailed guidelines from the WHO have evolved and many countries construct their own requirements based on these guidelines.
GMP offers systems to ensure consistency and quality of pharmaceutical goods. It involves rigorous testing to minimize risk for patients. GMP regulations address everything from equipment and raw product verification to personnel qualifications and cleanliness. Additionally, GMP requires testing that confirms the purity, safety and dosage of products, thereby reducing or eliminating the risk of contamination or errors.
GMP in Australia
Globally and in Australia, cGMP is another term utilised, where the ‘c’ stands for current, enforcing the necessity for companies to maintain current standards and stay up to date with regulatory changes. Australia holds itself to the highest standard of GMP guidelines and regarding medical cannabis production companies are required to hold a license to Manufacture Therapeutic Goods (GMP) and maintain cGMP.
In Australia, GMP is overseen by the Therapeutic Goods Administration (TGA), who regulate all medicines, undertake inspections and audits to ensure standards are adhered to. A number of production and manufacturing licenses have been approved for medical cannabis in Australia, however as yet, few companies are producing for the local market.
Importing medical cannabis – a GMP crisis waiting to happen?
While numerous studies have confirmed the safety and tolerability of cannabis medicines, as well as its lack of adverse side effects, there are still questions surrounding the quality of imported products. Considering the majority of cannabis medicines used by Australians at this time are imported, this raises concerns regarding quality, purity and consistency of such products.
While doctors prescribing medical cannabis are doing their best to ensure patient safety, professional education surrounding cannabis is still in its infancy and doctors may not be well informed on the products they are importing. Australia has stringent regulations surrounding the prescription of medical cannabis and approvals must be met regarding types of product prescribed. However, controlling the consistency in GMP of imported product is unreliable, particularly at the rate the Australian market is growing.
So, can we expect to see a crisis or harm coming to patients using uncertified GMP cannabis products? Unlikely.
The safety of cannabis medicines has been extensively tested in varied forms across the globe. While consistency in the therapeutic action of products and the risk of contamination are surely still concerns, patients may be equally concerned about the risk to their hip pocket for well-tested pharmaceutical-grade products, as they could be to their health.