As one of Australia’s longest-standing sponsors and distributors of medicinal cannabis, Novachem welcomes the Therapeutic Goods Administration’s wide-ranging consultation into quality, safety, and access pathways. With 519 released submissions (out of a total of 790) —most from consumers and patients (72%) but with an important cohort of industry sponsors—this process surfaces both the optimism and the tensions shaping our sector. Below we outline how the key findings intersect with Novachem’s submission, and how we believe the industry can move forward in a way that supports prescribers and patients while meeting the TGA’s expectations of quality, consistency, and accountability.

1. Quality and Safety Must Be Non-Negotiable

• Consultation insight: 62% of respondents believe current quality and safety settings are appropriate, yet 60% still called for changes to quality requirements—evidence that confidence is conditional on continued improvement.
• Novachem’s position: Every product—imported or locally manufactured—should meet identical, validated standards. We have urged the TGA to mandate PIC/S-aligned GMP, independent batch testing (e.g., 1st, 3rd, 6th, 10th, then every 10th batch), Continuous Process Verification, and routine surveillance sampling in Australia. Compounded inputs must meet the same quality bar as finished goods.
• Industry implication: The sector is broadly supportive of tighter controls when they translate into predictable supply chains and trusted medicines. Strong enforcement across all sponsors removes the competitive disadvantage faced by companies already investing in compliance.

2. Labelling and Transparency: Patients Want More

• Consultation insight: Two-thirds (66%) felt TGO 93 labelling is adequate, yet free-text responses (Q9 and Q29) reveal high demand for richer cannabinoid data, batch traceability, and clearer regulatory status.
• Novachem’s proposal: Align TGO 91 and TGO 93 labelling with a new Australian Register of Cannabinoid Therapeutic Goods (ARCTG). Each product receives an AUST C identifier, QR-linked batch CoAs, standardized cannabinoid profiles (mg/mL and % w/w), storage guidance, contraindications, pregnancy/breastfeeding warnings, and Black Triangle prominence to reinforce pharmacovigilance. Packaging should remain generic, with branding secondary to clinical information.
• Patient sentiment vs. sponsor responsibility: Patients are asking for the same proof points Novachem already supplies to prescribers—batch certificates, GMP credentials, and sponsor accountability. A centralised registry provides that assurance at scale.

3. Dosage Forms, Vaping, and High-THC Products

• Consultation insight: Safety concerns cluster around inhaled high-THC formats (Q10–Q18). While 68% see no unacceptable dose-form/route combinations, respondents flagged concentrate vapes, flavoured distillates, and child-attractive edibles as riskier.
• Novachem’s stance:
  • Restrict or prohibit high-THC vaping products that rely on flavourants, colourants, or non-validated excipients—citing international EVALI data and excipient degradation risks.
  • Permit inhaled concentrates only when they are direct resin extractions without additives, and pair them with validated medical devices (e.g., SyqeAir) where dosing is metered.
  • Require child-resistant closures and neutral flavour profiles for orally dosed formats such as pastilles or gummies.
• Balancing innovation and caution: Industry innovation remains essential, but dosage forms without robust safety data should pass through a registration pathway before wide release. This is the only way to maintain public confidence in cannabinoid therapeutics.

4. Safeguarding Vulnerable Populations

• Consultation insight: Responses were strongly supportive of current paediatric safeguards (70% said the specialist letter requirement is appropriate) and called for further risk mitigation in pregnancy/breastfeeding (41% said “Yes” to additional restrictions) and other vulnerable groups (41% “Yes,” 41% “No” for mental health/addiction histories—highlighting divided views).
• Novachem’s submission:
  • Maintain strict paediatric oversight: THC prescribing for under-18s only via specialist paediatricians, with THC capped at 5 mg per unit dose. Non-metered inhalation should be off-limits except under specific TGA authorisation.
  • Apply the precautionary principle to pregnancy and lactation, with clear contraindications and mandatory label warnings.
  • Flag higher monitoring needs for patients with psychiatric conditions, cardiovascular disease, substance-use histories, the elderly, and heavy former recreational users.
• Patient sentiment vs. safety: While many patients advocate broader access, the consultation shows strong acceptance of nuanced safeguards. Novachem’s approach keeps access open but ensures prescribers document and monitor higher-risk cohorts.

5. Access Pathways: Reconciling Patient Anxiety with Regulatory Assurance

• Consultation insight: 82% of respondents opposed restricting access via SAS and AP (Q25), reflecting patient anxiety about losing current pathways. Yet 61% offered ideas for new regulatory options (Q24), indicating readiness for reform if continuity is guaranteed.
• Novachem’s proposal:
  • Establish the ARCTG/ARAT register from January 2026, with unregistered supply ceasing January 2027.
  • Require GACP/PIC/S GMP dossiers, three-batch validation at registration, ongoing surveillance testing, and centralized data access.
  • Introduce cost-recovery mechanisms (e.g., a levy per milligram of THC) to fund proactive compliance.
  • Limit SAS/AP to exceptional cases once ARCTG is live, keeping it as a safety valve rather than the default.
  • Expand Schedule 3 access for low-dose CBD (≤200 mg/day, 50 mg per discrete dose) when products are ARCTG-registered, while setting a formal 50 mg/day THC guidance cap for Schedule 8 prescribing.
• Addressing the tension: Patients are understandably wary of losing SAS/AP flexibility. Novachem’s plan couples tighter gatekeeping with guaranteed supply of quality-verified products, prescriber education (CAP accreditation), and transitional mechanisms so no existing patient is stranded. It’s a higher standard that keeps access stable rather than restricting it.

6. What Comes Next

To align industry momentum with patient expectations and the TGA’s regulatory objectives, Novachem recommends:

1. Formal adoption of ARCTG: A bespoke cannabinoid register with AUST C identifiers, mirroring New Zealand’s pathway and ensuring any product sold in Australia is visible, audited, and recall-ready.
2. Mandatory surveillance and CPV: Regulators should not just set rules but verify them in-market. Shared batch data reduces duplication and speeds investigations.
3. Prescriber enablement: Expand the Cannabis Authorised Prescriber (CAP) framework with targeted training; allow nurse practitioners with advanced training to participate; and provide decision-support tools (dose-equivalence tables, metabolic pathway guidance).
4. Industry accountability: Sponsors must invest in GMP manufacturing, independent analytics, validated devices, and proactive risk communication. Novachem has already embedded these practices and will support peers to lift their standards.
5. Transparent communication with patients: Emphasise that higher-quality requirements are not about denying access—they’re about ensuring every bottle, capsule, or device meets the same therapeutic standard, regardless of origin.

Closing Thoughts

The consultation confirms what we hear daily from clinicians and patients: medicinal cannabis is delivering meaningful relief, but trust hinges on consistent quality, clear labelling, and honest communication about risk. Novachem’s submission to the TGA argues for exactly that: a supportive yet disciplined framework that keeps Australia at the forefront of cannabinoid therapeutics.

We stand ready to work with regulators, prescribers, and patient advocates to implement these reforms—ensuring every product we sponsor meets the standard of care Australians deserve.