Novachem’s submission to the TGA’s Medicinal Cannabis Review pushes for an Australian Register of Cannabinoid Therapeutic Goods (ARCTG/ARAT), tighter controls on high-risk dosage forms, and stronger protection for vulnerable groups. Here’s how that position compares with patient, industry, clinician, and government feedback captured in the consultation dataset.
Snapshot: respondents vs. Novachem
| Theme | Patients/Consumers | Medical Practitioners | Government/Regulators | Broader Industry | Novachem’s position |
|---|---|---|---|---|---|
| Quality controls | Worry about inconsistent potency and contaminants; want clearer lab results | Want batch-level validation and easier access to Certificates of Analysis | Emphasise enforceable testing + compliance monitoring | Split: some want lighter-touch import testing, others push for NZ-style register | Full ARCTG dossier, identical standards for local/imported product, PIC/S GMP, surveillance testing on every batch |
| Labelling | Desire plain-language directions, contraindications, QR-coded info | Need standardized dosing, route guidance, maximum daily intakes | Require SUSMP/TGO compliance and pregnancy warnings | Mixed: brand-forward packaging vs. plain-pack lobby | TGO 91 + 93 compliant, generic labelling, Black Triangle, pregnancy warnings, AUST C ID tied to public database |
| Dosage forms | Concern about vape carts, gummies appealing to teens | Prefer metered oils/capsules; cautious on inhalation | Flag risks with high-THC vapes and concentrated extracts | Some defend existing product mix | Ban flavoured vape carts, restrict high-THC inhalation to unadulterated resins, require CRCs for pastilles, meter dosing |
| Vulnerable groups | Support tighter controls for minors, pregnancy, mental health | Want prescriber training + guidance for tricky cohorts | Advocate explicit contraindications in scheduling | Mixed | Maintain paediatric specialist oversight, cap THC at 50 mg/day, discourage use in pregnancy/breastfeeding, caution in psychiatric/cardiac patients |
| Access pathway | Patients want continuity without red tape | Clinicians struggle with SAS-B complexity | Governments wary of SAS/AP being de facto register | Industry divided (status quo vs. structured register) | Shrink SAS/AP to exceptional cases, establish ARCTG/ARAT with AUST C numbers, CAP training for prescribers |
Patients and carers: safety first, but don’t break continuity
Across ~1,200 public responses, patients repeatedly called out:
- Inconsistent potency and lack of batch transparency.
- Confusion around label instructions and warning statements.
- Anxiety about “vape-style” products that look like confectionery and are accessible to teens.
Novachem aligns on these pain points through its ARCTG proposal:
- Every batch (local or imported) would undergo independent validation (1st, 3rd, 6th, 10th and every 10th batch thereafter) plus random surveillance testing in Australia.
- Plain-pack style labelling (TGO 91) with QR links to a TGA-hosted dossier gives patients and carers instant access to Certificates of Analysis, stability data, contraindications, and dosing notes.
- Child-targeted dose forms (pastilles, flavoured carts) are flagged for child-resistant closures or prohibition.
Where Novachem diverges from some patient advocates is the call to tighten SAS/AP. While consumers fear losing access, Novachem argues a one-year transition (2026–2027) ensures continuity while sponsors build AUST C dossiers. After 1 Jan 2027, high-quality registered products would be available through CAP prescribers, with SAS/AP used only for exceptional cases—still safeguarding access, but without the “anything goes” loophole.
Medical practitioners: dosing clarity and prescriber accountability
Clinical contributors (GPs, specialists, nurse practitioners) told the TGA they need:
- Standardized dosing guidance, especially for THC vs. CBD ratios.
- Clear maximum daily limits and route-specific cautions.
- Certainty that products presented as “pharmaceutical grade” have actually been through GMP oversight.
Novachem’s submission mirrors those requests:
- 50 mg/day cap on THC (adjusted for route/bioavailability) to anchor prescribing decisions; “start low, go slow” remains the default.
- Encourage an AHPRA-backed Cannabinoid Access Program (CAP) so prescribers have formal training and automatic authority to prescribe any ARCTG-listed product; SAS-B remains for non-CAP prescribers with TGA review.
- Mandate labelling that ties every SKU to a public registry entry (AUST C), with QR-coded prescribing info, contraindications, and batch-level data.
Difference vs. general clinician feedback:
- Some doctors asked for more flexibility on high-THC inhalation; Novachem is firmer—unmetered vape products with flavourants should be banned outright, and only metered inhalers like SyqeAir get conditional support.
Government and regulators: turning policy into enforcement
Regulatory submissions (state health departments, advisory bodies) emphasised enforceable quality assurance, cost recovery, and protection for vulnerable cohorts.
Novachem adds detail:
- ARCTG/ARAT cost recovery via registration fees plus a micro-levy (e.g., 0.5 ¢/mg THC) to fund surveillance, random sampling, and lab capacity.
- Governance split: sponsors accountable for manufacturing quality; prescribers accountable for clinical justification; TGA can outsource surveillance/lab validation to accredited third parties to keep pace with demand.
- Scheduling tweaks: keep THC in S8 but align dosing guidance with the 50 mg/day cap; expand S3 CBD access for ARCTG-registered products ≤200 mg/day.
Industry peers: divided camp, Novachem pushes for NZ-style compliance
Industry submissions were split:
- Status-quo camp: Keep SAS/AP wide open; rely on existing import testing.
- Structured camp: Move toward a New Zealand-style register (Medicines Act Part 6 compliance).
Novachem sides with the structured camp (and arguably goes further):
- Importers can keep supplying, but must meet the same GACP/GMP standards and prove it at registration—no “lighter” rules for overseas batches.
- Three qualifying batches at registration and routine CPV means only mature manufacturing programs survive.
- Overseas labs must be ISO 17025 accredited; Australian surveillance testing catches outliers.