TGA Update to Accelerate Empax Therapist Recruitment
Released
Released
Announcement PDF
Emyria ASX Announcement | 28 May 2026
ASX RELEASE.
28 May 2026
TGA Update to Accelerate Empax Therapist
Recruitment
Regulatory Catalyst broadens Emyria’s Empax Clinic Recruitment Profile
Key Highlights:
• Updated TGA Recommendations facilitate and accelerate recruitment to Empax
clinic’s 100+ strong Australia-wide clinician network, broadening eligible disciplines
required as part of the psychedelic-assisted psychotherapy dyad1
.
• Emyria welcomes the recommendations including scope expansion for additional
therapists to include Aboriginal and Torres Strait Islander Health workers to support
culturally safe care in Australia.
• Company expects benefits to take effect H2 CY2026 after final TGA endorsement,
workforce planning, recruitment and training.
Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”), a leader in innovative mental health
treatments, welcomes the Therapeutic Goods Administration’s (TGA) announcement of
changes to its recommendations for the Authorised Prescriber (AP) scheme for psychedelic-
assisted psychotherapy (PAT).
The updated recommendations expand the range of clinicians required as one of the two
therapists in the psychedelic-assisted psychotherapy “dyad”, which to date has mandated a
clinical psychologist or medical practitioner be present during dosing.
Under the changes, the TGA confirmed yesterday that the dyad can now include a broader
range of trained therapists registered with one of the following national boards: psychology
(with clinical endorsement), medical (general registration), nursing and midwifery (with
mental health experience), or occupational therapy (where scope of practice includes
psychedelic-assisted psychotherapy).
The Authorised Prescriber may then use professional discretion to determine other members
of the therapy team that may be considered including psychotherapists, counsellors, social
workers, and Aboriginal and Torres Strait Islander health workers.
Direct benefit to Emyria’s national Empax network
The expanded eligible workforce is expected to:
• improve clinic utilisation through more flexible dyad configurations and reduced
reliance on clinical psychologists;
• accelerate recruitment of appropriate therapists across each jurisdiction;
• diversify Emyria’s clinical workforce, including supporting culturally appropriate care;
and
• ultimately improve patient access to important treatment options across Emyria’s
national footprint.
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Implementation pathway
The recommendations will require final approval before taking effect with benefits of the
changes expected to be realised in H2 CY2026. Having previously successfully navigated the
process on multiple occasions, Emyria will be required to update existing care models and
submit for review by the Company’s ethics committee before final endorsement by the TGA.
The Company has already commenced revised workforce planning in preparation for the
announced regulatory changes.
A positive signal from an engaged regulator
Emyria views the TGA’s announcement as a positive and pragmatic adjustment reflecting
growing real-world evidence and experience with psychedelic-assisted psychotherapy. The
Company expects further pragmatic changes to the framework over time as clinical evidence
and operational experience continue to grow.
Executive Chair Greg Hutchinson commented:
“This is a welcome and pragmatic step from the TGA. Broadening the disciplines that can
lead psychedelic-assisted psychotherapy will directly support our recruitment efforts, help
diversify our workforce, and improve utilisation and patient access across our national
Empax network. We see this as recognition of a regulator that is willing to engage and
respond, and we expect further sensible adjustments over time as the body of clinical
evidence and real-world experience continues to grow.”
This release has been approved by the Chair of Emyria.
For further information, investment opportunities, or more about Emyria’s approach to mental
health treatment, please contact:
Greg Hutchinson
Executive Chair
1300 436 363 | investors@emyria.com
References:
1. TGA, Targeted consultation on AP scheme for psychedelics https://www.tga.gov.au/news/news-
articles/updates-authorised-prescriber-ap-scheme-requirements-when-accessing-mdma-and-
psilocybine
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Emyria ASX Announcement | 28 May 2026 3
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS Any statements in this press release about future
expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other
statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements. Actual results may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including: the Company’s ability to successfully develop its
product candidates and timely complete its planned clinical programs and the Company’s ability to obtain
marketing approvals for its product candidates. In addition, the forward-looking statements included in this
press release represents the Company’s views as of the date hereof. The Company anticipates that subsequent
events and developments will cause the Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the future, the Company specifically disclaims any
obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s
views as of any date subsequent to the date hereof.
Risks associated with the use of MDMA, MDMA-inspired compounds and psilocybin
All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the
suitability of a new medication against a patient’s individual circumstances and medical history before
proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic
attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include
involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint
stiffness. Adverse effects of psilocybin can include temporary increase in blood pressure and a raised heart rate.
There may be some risk of psychosis in predisposed individuals. The effects of MDMA and psilocybin are unlikely
at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately
managed in a controlled environment with direct medical supervision. The risk profile of the MDMA inspired
compounds is currently unknown.
The availability of these products is subject to the safety and efficacy of the products being tested through
clinical trials. Emyria makes no representations or warranties as to the safety or efficacy of the products or the
products’ ability (or the ability of its key compounds) to be used in the treatment of indications such as PTSD.
There are currently no approved products containing MDMA, psilocybin or MDMA inspired compounds that the
TGA has evaluated for quality, safety and efficacy.
Emyria Limited develops and delivers new treatments for mental health and select neurological
conditions through an integrated model of direct clinical services and treatment development:
Emyria Healthcare: Evidence-based treatment for patients not finding relief
from conventional care while also helping evaluate emerging new therapies like
assisted therapy for PTSD and assisted therapy for treatment-resistant depression.
Emyria Data: Robust and ethically sourced Real-World Data gathered with patients
to improve Emyria’s unique therapy and drug development programs.
Emyria’s Pipeline: New psychedelic-assisted therapies and drug treatments for mental
health and select neurological diseases.
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