Asia-Pacific Roundup: TGA seeks feedback on planned rejection of call to change psilocybin classification
The Therapeutic Goods Administration (TGA) is holding a consultation on its interim decision to reject the reclassification of psilocybin in Australia.
An applicant asked TGA to allow the supply of psilocybin as part of psychotherapy in medically controlled environments to treat existential distress toward the end of life. The molecule, the active ingredient in “magic mushrooms,” is a controlled, Schedule 8 drug indicated for use in treatment-resistant depression.
In an interim decision, TGA ruled that there was insufficient evidence to support changes to the current scheduling, reflecting a belief that the proposal contained limited evidence of the therapeutic efficacy and safety of psilocybin-assisted psychotherapy in the treatment of end-of-life distress. TGA’s committee said the clinical trials used as evidence were small and lacked methodological rigor. A recent Cochrane review found mixed results from clinical trials and a high degree of uncertainty in the evidence.
The committee also raised concerns with diagnostic and treatment pathways. Existential distress is not a diagnostic category in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, TGA said, and its diagnosis depends on interpretation, the surrounding circumstances, and cultural norms. There is no validated, internationally accepted diagnostic tool for existential suffering or distress.
The applicant’s proposal for identifying prescribers and reviewing clinicians was ambiguous as well, TGA said, and the role of pharmacy compounding warrants further elaboration. Other issues identified by the committee included the impact of the change on state and territory poisons and medicines regulators.
TGA is consulting on the decision, asking patients, drugmakers, and other groups whether they support, partially agree with, or disagree with its interim ruling. Respondents can upload a document to provide a longer written response to the consultation.
The consultation held before the meeting suggests there will be opposition to the interim decision. TGA received 595 public submissions during the pre-meeting consultation period, 590 of which supported the proposal to extend psilocybin’s indications to include existential, end-of-life distress. Three respondents partially supported the proposal. The remaining two respondents disagreed with the proposal.
One opponent to the proposal, Palliative Care Australia, raised concerns that the research in the area remains experimental and is insufficient to support routine use. The organization, which represents the palliative care sector, raised concerns about the ambiguity of the qualifications and training required to deliver the proposed therapy.
The consultation closes on 3 July.
TGA Consultation, Interim Decision
Japan’s PMDA shares guidance on biosimilars, mRNA vaccines, and in vivo diagnostics
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has released English-language guidance documents on topics including biosimilars, mRNA vaccines, and in vivo diagnostics.
The translations are part of a series of “early consideration” documents that PMDA has created to help companies navigate emerging areas. One of the documents explains how to determine whether a sponsor needs to run a comparative efficacy study to demonstrate that an off-patent biologic is biosimilar to its reference product. Recent Japanese guidance clarified that such studies may no longer be necessary.
PMDA’s early consideration document explains how to assess if a comparative efficacy study is needed. Biosimilar developers should use product quality and clinical trial data to clearly explain the rationale for omitting comparative efficacy studies, PMDA said. The relationship between a drug’s quality attributes and its pharmacokinetics, efficacy, safety, and immunogenicity should be part of the rationale.
Officials released the biosimilar guidance alongside translations of other early consideration documents. The mRNA guidance covers the use of a platform-based approach to nonclinical evaluation of the safety of mRNA infectious disease vaccines delivered using lipid nanoparticles. Under the guidance, companies can use data on approved mRNA vaccines to reduce the need for animal testing of candidates based on the same platform.
The in vivo diagnostics guidance addresses medicinal products, such as radiopharmaceuticals, that are directly administered to the human body to diagnose disease. No guidelines specifically address the clinical development of in vivo diagnostics. Rather, PMDA considers R&D strategies on a case-by-case basis. The document outlines fundamental considerations for clinical development of in vivo diagnostics.
‘Operational difficulties’ prompt India’s CDSCO to adopt workaround for notification system
India’s Central Drugs Standard Control Organization (CDSCO) has established an alternative process for filing some import requests after users encountered problems with the system.
CDSCO recently created the “prior intimation” notification pathway to streamline the initiation of some studies. However, users identified a problem with the link between parts of the Sugam portal used to file the notifications and handle import requests. In light of the “operational difficulties” reported by users, CDSCO has established an interim procedure to address these issues.
Applicants importing a reference-listed drug or an investigational medicinal product for use in bioavailability or bioequivalence studies must submit a cover letter. The letter should explain the purpose of the import and reference details of the prior intimation filing, including a copy of the acknowledgment to the submission generated in the Sugam portal.
CDSCO imposed the cover letter requirement in response to the “non-availability of system linkage” between prior intimation and import forms in Sugam. Applicants should use the interim procedure until further notice.
Singapore’s HSA answers industry questions about regulatory reliance with Malaysia’s MDA
Singapore’s Health Sciences Authority (HSA) has provided an update on medical devices and diagnostics, including clarifications of the reliance mechanism it recently established with its Malaysian counterpart.
As part of a webinar on regulatory updates, HSA answered questions about its reliance agreement with Malaysia’s Medical Device Authority (MDA). HSA clarified that the turnaround time for approvals based on MDA authorizations is the same as for other reference agencies. MDA approvals can support filings for HSA’s abridged evaluation route, but not for its expedited and immediate pathways.
Other questions addressed the acceptability of screenshots of listings extracted from an MDA system and HSA’s approach to products approved in Malaysia via verification by a conformity assessment body (CAB). Devices must have undergone full conformity assessment by an MDA-recognized CAB to be eligible for abridged evaluation in Singapore.
HSA also addressed other topics, including guidelines on artificial intelligence in healthcare, audits of medical device dealer license applications, risk classification of COVID-19 tests, and an initiative targeting unregistered medical devices accessed through the special access route.
Other news
TGA published a notice about AA-Med’s recall of Dexcom G7 sensors. The two recalled lots were flagged for disposal and destruction in the US due to incomplete sterilization and deployment failures during testing. However, the continuous glucose monitors were stolen during disposal and sold to third parties through unauthorized channels. Stolen devices could reach the Australian market. TGA Notice
CDSCO published guidance on the sampling of drugs and medical devices by central and state inspectors. The Indian agency created the guidance to streamline and rationalize sampling to maintain monthly updates on products that are spurious or fail quality tests. The guidance covers topics such as choosing sampling locations and how many samples to collect and test. CDSCO Guidance
TGA published a notice about the discontinuation of an antibiotic. The agency plans to work with other companies to monitor supply and smooth the transition to alternative products. TGA Notice
