GMP, GACP, TGO and PIC/S… Dip your toe into Australian medicinal cannabis standards and you’ll soon find yourself in a sea of acronyms – part and parcel with regulation and policy. But once you get past the jargon, you’ll find a great deal of substance designed to keep Australians safe. And with the industry growth, it’s more important than ever to ensure that patient safety remains at the fore.

In this article, we will delve into the standards that apply to medicinal cannabis cultivation, production and distribution to protect the safety and well-being of Australian patients. 

Quality standards for medicinal cannabis in Australia

The Therapeutic Goods Administration (TGA) plays a crucial role in ensuring the safety of therapeutic goods in Australia and is responsible for overseeing the country’s growing supply of cannabis medicines.

To assess medicinal cannabis products, the TGA draws on both Australian and international frameworks, including:

1. Good Manufacturing Practices (GMP) as defined by the Pharmaceutical Inspection Co-operation Scheme (PIC/S)
2. Good Agricultural and Collection Practices (GACP) as defined by the World Health Organisation (WHO) for medicinal plants ‍
3. Therapeutic Goods Order (TGO) 93
   

What is the PIC/S guide to GMP?

Different countries and industries have varying standards for what constitutes Good Manufacturing Practices (GMP) and Australia has adopted the guidelines defined by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) for its medicines. It applies to finished cannabis medicines and active pharmaceutical ingredients (bulk cannabis products).

PIC/S is an informal agreement between regulatory authorities to harmonise pharmaceutical standards between countries. As the prevailing standard in all EU countries, it is sometimes referred to as EU-GMP – notably distinct from the standards imposed on cannabis by the USA and Canada. 

What is GACP?

As a herbal medicine, medicinal cannabis is also subject to specific requirements regarding how it is grown, collected, harvested, cut and dried. The guidelines, called Good Agricultural and Collection Practices (GACP), are important because factors like seed selection, cultivation and harvesting conditions can significantly impact the quality of the finished product. 

As part of holding an Australian GMP license, cannabis manufacturers must ensure the plants are produced in line with GACP standards as defined by the WHO, TGO 93 and the PIC/S GMP, specifically Part 1 (Basic Requirements for Medicinal Products) and Annex 7 (Manufacture of Herbal Medicinal Products).

What is TGO 93?

Therapeutic Goods Order (TGO) 93 is a set of standards established by the TGA that applies to all Medicinal Cannabis products, both ingredients and finished products, supplied in Australia. 

TGO 93 covers a range of aspects, including:

• Plant identification - using macroscopic, microscopic and chromatographic methods
• Product stability
• Potency of the active ingredients 
• Yeast, mould and microbial content
• Testing for a range of contaminants including heavy metals, aflatoxins, pesticides, ash and more
  

In summary

Medicinal cannabis in Australia is subject to strict quality regulation by the TGA using international and local frameworks. There are standards for each part of the supply chain to ensure cannabis medicines are cultivated, manufactured and supplied with quality practices from seed to shelf. All of this is done to protect Australian patients and provide assurance that the medicines they receive are high quality, safe and effective. 

Wanting to learn more about medicinal cannabis in Australia? Read our FAQs for Western Australian and Queensland patients.