Australia TGA Reviews Medicinal Cannabis Rules Amid Safety Concerns

Europe’s cannabis industry is rapidly evolving, with Germany leading regulatory reforms that expand medical cannabis access and liberalize industrial hemp use, positioning the sector for substantial growth through 2030. In the U.S., the FDA has recommended rescheduling medical marijuana to Schedule III, which could facilitate pharmacist-led dispensing and clinical oversight of cannabis products, marking a significant shift in medical cannabis regulation and availability. Meanwhile, Australia’s Therapeutic Goods Administration (TGA) is reviewing its medicinal cannabis access rules amid concerns over the widespread use of unapproved products, particularly those with high THC content, which have not undergone formal quality or safety evaluations. The TGA consultation highlights issues with the current unapproved goods pathways, originally intended for limited use, now overwhelmed by high patient numbers and product diversity, raising safety concerns including patient harm and psychosis. There is broad call for a more holistic regulatory approach in Australia, addressing telehealth prescribing practices and ensuring better oversight and data collection to safeguard patient health and improve product standards. These developments reflect a global trend toward balancing increased access to medical cannabis with enhanced regulatory frameworks to manage safety, efficacy, and quality.