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<p>There is an established process for the development of medicines, which enables
medicines (including those containing Schedule 1 drugs such as psilocybin) to be developed,
evaluated in clinical trials and licensed based on an assessment of their safety,
quality and efficacy.</p><p> </p><p>The Government recognises that a number of studies
into the potential use of psilocybin as part of the treatment for mental health conditions
have been or are being conducted in the UK. However, medicines based on psilocybin
have not yet been licensed by the Medicines and Healthcare Products Regulatory Authority
(MHRA) which would address safety, quality and efficacy concerns. Ministers could
seek advice from the ACMD about the rescheduling of psilocybin-based products on the
basis of evidence of the therapeutic use of unlicensed medicines, but we would ordinarily
do this only in consultation with the Department for Health and Social Care and the
MHRA.</p><p> </p><p>The MHRA continues to support the safe and scientifically sound
conduct of trials in this area and also to provide regulatory and scientific advice
to companies at all stages of developing medicines. Should a company apply for a marketing
authorisation (a product licence), it will ultimately be a decision for the MHRA whether
to license a psilocybin-based medicine as a therapy.</p><p> </p><p>If a psilocybin-based
medicine is made available following an assessment of its quality, safety and efficacy
by the MHRA, the Home Office will seek and then consider advice provided by the Advisory
Council on the Misuse of Drugs (ACMD) on its scheduling under the Misuse of Drugs
Regulations 2001 as soon as possible. Such advice is a statutory requirement and will
be considered before any decision is taken on scheduling under the 2001 Regulations.</p>
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