Novachem has recently provided a formal submission to the Therapeutic Goods Administration (TGA) consultation on Reviewing the Safety and Regulatory Oversight of Unapproved Medicinal Cannabis Products .

As a long-standing sponsor of medical products, Novachem welcomes this opportunity to help shape a safer, more accountable regulatory framework for medicinal cannabis in Australia. Our position is clear: patient safety, compliance, and accountability must remain at the centre of regulation.

Why Reform is Needed

The current reliance on the SAS-B and Authorised Prescriber (AP) pathways has allowed unapproved medicinal cannabis products to become the default route of supply. These products often vary in quality, provenance, and evidence base, undermining both public confidence and incentives for proper registration .

Novachem believes that sponsors must bear direct responsibility for the quality and safety of their products, and that consistent, enforceable oversight is required to protect patients while enabling sustainable sector growth.

Our Key Recommendations

In our submission, Novachem has called for the establishment of a new, dedicated regulatory framework to bring medicinal cannabis into line with global best practice. The major proposals include:

• Creation of a Dedicated Register:

  Establish the Australian Register of Cannabinoid Therapeutic Goods (ARCTG) (or Australian Register of Alternative Therapeutics – ARAT), where all products must be listed with a unique identifier (AUST C), similar to existing AUST L and AUST R medicines .

• Mandatory Transition:

  From 1 January 2026, all new products should commence transition to ARCTG/ARAT registration, with only registered products permitted for supply after 1 January 2027.

• Stricter Dossier Requirements:

  Products must demonstrate compliance with GACP and PIC/S GMP, validated shelf life, and independent batch testing, with Certificates of Analysis lodged in a centralised online database accessible to practitioners and patients.

• Cost Recovery and Sustainability:

  Introduce a per-milligram levy on active cannabinoids to fund ongoing pharmacovigilance, surveillance testing, and regulatory oversight, following international precedents in Canada and Germany.

• Standardised Labelling and Risk Communication:

  Labels must comply with TGO 91 and 93, include mandatory contraindication statements, display the AUST C identifier, and direct users to batch-specific compliance data via QR code or web link.

• Prescriber Accreditation (CAP Framework):

  A Cannabinoid Approved Prescriber (CAP) program should ensure prescribers are appropriately trained, with expanded eligibility for nurse practitioners who complete accredited training.

• Device Regulation:

  Only metered, validated medical devices (e.g., SyqeAir inhaler) should be permitted; consumer-grade vape pens must be prohibited.

• Clinical Governance:

  Oversight by AHPRA to ensure prescribing aligns with best practice, supported by sponsor accountability for product safety and quality.

Building a Safer Future

This framework would move Australia away from fragmented, inconsistent pathways and toward a sustainable, transparent system that protects patients and strengthens public confidence. By aligning with international best practice and introducing the ARCTG, Australia can ensure that medicinal cannabis products meet rigorous standards of safety, quality, and accountability .

Read Novachem’s full submission here.

Have your say....

Interested parties can respond to the TGA Consultation request until October 7.