PSA backs TGA action on medicinal cannabis safety, urges broader regulatory reform

11 August 2025

 

The Pharmaceutical Society of Australia (PSA) welcomes the Therapeutic Goods Administration’s (TGA) consultation to address growing safety concerns surrounding unapproved medicinal cannabis products, commencing today 11 August 2025.

 

With more than 1,000 products currently accessed through the Special Access Scheme (SAS) and Authorised Prescriber (AP) scheme, PSA National President Associate Professor Fei Sim FPS is calling for reform that ensures medicinal cannabis is prescribed and dispensed safely, with appropriate oversight.

 

“PSA commends the TGA for taking action to address the growing safety concerns of both healthcare professionals and our community,” Associate Professor Sim said.

 

“Unregistered medicinal cannabis products pose serious challenges, including inconsistent dosing, limited safety data, and minimal post-market surveillance. These gaps increase the risk of harm and demand greater care in prescribing.

 

“The SAS and AP scheme were designed for unique clinical situations, not as a loophole for hundreds of products to bypass regulatory scrutiny.

 

PSA supports the use of medicinal cannabis when clinically appropriate and overseen by qualified health professionals. However, the current system leaves pharmacists and prescribers without the tools they need to ensure safe and informed use.

 

PSA will engage with subject matter experts and the broader profession to inform its submission to the TGA and is committed to partnering with government to reduce harm from unapproved medicinal cannabis products.

 

While the TGA has acknowledged that product-specific telehealth and digital services fall outside its scope, PSA is calling on other regulators to step up scrutiny of vertically integrated, direct-to-consumer business models.

 

“More needs to be done to curtail aggressive telehealth services that, in many cases, appear to lack robust clinical governance. There is a place for medicinal cannabis products, but we need to prioritise the tools and regulatory environment that promote their safe and appropriate use,” Associate Professor Sim concluded.

 

Media contact: Georgia Clarke M: 0480 099 798 E: georgia.clarke@psa.org.au