Asia-Pacific Roundup: TGA relaxes rules on psilocybin, MDMA to enable prescribing by psychiatrists

RoundupsRoundups | 07 February 2023 |  By 

Australia’s Therapeutic Goods Administration (TGA) is set to reclassify the psychoactive substances MDMA and psilocybin to enable authorized psychiatrists to prescribe them for the treatment of certain mental health conditions. The ruling overturns the interim decision that officials reached last year.
The new rules, which take effect on 1 July, permit the prescribing of MDMA for the treatment of post-traumatic stress disorder and psilocybin for use in people with treatment-resistant depression. Both drugs must be given in combination with psychotherapy in medically controlled environments. In those circumstances, TGA is down-scheduling MDMA and psilocybin from Schedule 9 to Schedule 8 to facilitate the therapeutic use of the drugs.
MDMA and psilocybin can only be prescribed by medical practitioners that are registered as specialist psychiatrists. The drugs may also be used in clinical trials once the study has been approved in Australia.
The decision comes months after an interim decision that found “insufficient additional evidence” of the therapeutic value of MDMA and psilocybin and proposed keeping the drugs in Schedule 9. Since then, TGA has received more than 3,000 public submissions in response to the interim decisions about both drugs. The author of the final decision said the number of submissions “is a reasonable indicator of the scope and gravity of the issues for individual and public health addressed” in the rescheduling request.
The final decision also drew on the results of a Phase 2 clinical trial of single-dose psilocybin for a treatment-resistant episode of major depression that were published in November. “The results of this study further strengthen the already promising body of evidence for the efficacy of psilocybin in the treatment of [treatment-resistant depression] and support my decision to increase the accessibility of this substance for this purpose,” the author of the final rescheduling decision wrote.
By limiting the use of MDMA and psilocybin to psychiatrists who are part of TGA’s Authorised Prescriber Scheme, officials hope to address the concerns that led some people to conclude the risks outweigh the benefits. The scheme allows authorized medical practitioners to supply medicines that are not included in the Australian Register of Therapeutic Goods to specified patients in their immediate care under some circumstances.
Work is now underway to prepare for the down-scheduling, with the Royal Australian and New Zealand College of Psychiatrists (RANZCP) planning to “develop further guidance for psychiatrists who apply to become TGA authorized prescribers.” In July, RANZCP said “clinical use of psychedelic substances should only occur under research trial conditions” in a memorandum that urged caution on permitting access to the substances for therapeutic use, in part because of the lack of established treatment protocols.
TGA Notice, RANZCP Statement
Philippine FDA seeks feedback on its regulatory requirements and activities during emergencies
The Philippine Food and Drug Administration (FDA) has released draft guidelines on regulatory responses to public health emergencies for consultation. FDA has created the guideline to lay down what happens when the Philippine president suspends or streamlines the usual requirements in response to a crisis.
FDA released an earlier version of the draft for consultation late last year. After collecting feedback, the agency has revised several sections of the text. FDA has revised its statement on when the president can use their powers to change the regulatory requirements, clarifying that it can happen simultaneously with the declaration of an emergency or at a later date, and updated its position on the next steps.
In the original draft text, FDA said it would issue a guideline within 15 days of the declaration of a public health emergency. The update clarifies that the guideline is due within 15 days of the president’s order, which could come after the declaration of a public health emergency and adds that the task force will communicate its plans to “concerned stakeholders” and coordinate with national and local agencies.
Finally, FDA has revised the process through which the work of the task force is monitored and assessed. Under the original proposal, the task force was required to “promptly provide” updates to the director general. The new plan calls for updates, reports and recommendations to undergo review by the crisis management committee, which will then share its recommendations with the director general for their approval.
FDA is accepting feedback on the draft until 15 February.
Draft Guidelines
Australia proposes reducing the maximum size of paracetamol packs to cut the risk of overdose
TGA has proposed limiting the maximum size of paracetamol packs in an interim decision. If finalized, the decision will reduce the maximum size of paracetamol packs sold in supermarkets, pharmacies and under the supervision of a pharmacist.
An independent expert report commissioned by TGA found 225 people in Australia are hospitalized after overdosing on paracetamol each year. Fifty people die every year, with the rates of intentional overdose highest in adolescents and young adults. The report informed a public consultation that TGA ran in the second half of last year and now looks set to lead to new restrictions on pack sizes.
“The report shows that severe paracetamol overdoses of 25 g or higher disproportionately cause severe liver toxicity. Concerningly, this threshold is less than 10 times the recommended maximum daily dose of paracetamol,” the author of the interim decision wrote. “On this basis, and in consideration of all the submissions received, I consider that restrictions on access to paracetamol must be tightened to address the increasing incidence of Australians intentionally overdosing with paracetamol.”
The interim decision limits General Sale and Pharmacy Only paracetamol to blister packages in the belief that it acts as more of a deterrent to the ingestion of a large number of tablets than containers with child-resistant closures. The number of tablets or capsules that can be sold will be reduced too, in the case of Pharmacy Only medicines from 100 to 32. Pharmacists will still be able to sell 100 tablet or capsule packs under their supervision.
The interim decision is open for feedback until 3 March.
TGA Notice
TGA defends performance of COVID-19 rapid antigen tests after call for ‘clean up’ of the market
TGA has defended the performance of COVID-19 rapid antigen tests after a researcher at James Cook University told ABC News there needs to be an “overhaul” and “clean up” of the products on the market.
The researcher, Patrick Schaeffer, made the comment after studying the ability of rapid antigen tests to detect low concentrations of SARS-CoV-2. Using engineered fluorescent nucleocapsid protein, the team showed that two of the 10 assessed tests identified the virus at low concentrations. Schaeffer called the analytical system currently used to test for sensitivity “probably the worst method available these days ... because it's highly variable.”
TGA responded to the report in its own statement. The agency said it disagrees with the assertions made by Schaeffer, stating that its own scientists performed an “in-depth evaluation of submitted data” on the marketed COVID-19 tests and that an independent assessment confirmed the tests meet the global sensitivity requirements.
Out of 91 tests analyzed by TGA, three failed to meet the minimum requirements and were removed from the Australian market. TGA continues to state that rapid antigen tests, when used correctly, are an important tool for detecting and managing COVID-19 infections.
TGA Notice, ABC News


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