How medicinal cannabis quality is regulated 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:
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.
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).
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:
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.
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