MELBOURNE, 24 November 2025 — Montu today welcomed the opening of the 2026–27 Pre-Budget Submission process, announced late Friday, marking the next phase of regulatory reform in a year that has already delivered significant progress for medicinal cannabis governance in Australia.

In its 2025-2026 Pre-Budget Submission a year ago, Montu called for additional resourcing for a future, TGA-led regulatory review to modernise medicinal cannabis oversight, improve regulatory clarity, and strengthen patient safety.

The TGA initiated a first round of consultation — an important milestone that aligns directly with the solutions Montu identified through its facilitation of an expert roundtable as essential to contemporary, evidence-aligned patient care.

Vice-President of Corporate Affairs and Patient Advocacy at Montu, Jodie Thomas, said the commencement of the new Pre-Budget cycle is an opportunity to build on this momentum.

“We welcome the progress achieved over the past year,” Ms Thomas said.

“This validation of our earlier recommendations underscores the importance of targeted, proportionate reform in this sector.

“As the new Pre-Budget cycle opens, Montu will again recommend targeted budget allocations to support evidence-informed, risk-proportionate policy work across government departments. It is essential that this next phase of reform strengthens prescriber education and the national evidence base, while preserving safe treatment options for appropriate patients.”

Montu’s submission to the Government will outline targeted, pragmatic reforms that prioritise national consistency, patient safety, and improved regulatory clarity.

Draft recommendations include:

1. Ongoing support for the TGA through its consultation process and beyond
Ensuring the regulator has the capacity and resources to progress the next phase of its review, implement reforms, and deliver a modernised medicinal-cannabis framework.

2. Continued support for the Australian Digital Health Agency (ADHA) and the Department of Health
Strengthening the national telehealth architecture and regulatory settings, ensuring virtual care remains safe, clinically robust, and accessible, particularly for patients in rural and remote areas.

3. Funding for a national medicinal-cannabis Real-World Evidence (RWE) database
Supporting a long-term data repository with de-identified clinical data that enables regulators and policymakers to anchor future decisions in robust Australian safety, efficacy, and quality data.