Psilocybin

There are no current plans to reschedule psilocybin under the Misuse of Drugs Act 1971, also known as the Act.

There is an established process for the development of medicines, overseen by the Medicines and Healthcare products Regulatory Agency (MHRA). This enables medicines, including those containing Schedule 1 controlled drugs under the Act, such as psilocybin, to be developed, evaluated in clinical trials, and licensed, based on an assessment of their safety, quality, and efficacy, before being made available to patients in the United Kingdom. Should an application be submitted for a marketing authorisation, for a product licence, it will ultimately be a decision for the MHRA whether to license psilocybin as a therapy. There are no psilocybin-based medicines with a marketing authorisation in the UK.

If a manufacturer is successful in being granted a marketing authorisation by the MHRA for a medicine containing psilocybin, the Home Office is committed to reviewing its scheduling under the Act, subject to advice from the Advisory Council on the Misuse of Drugs on the appropriate scheduling and safeguards for the medicine.

The National Institute for Health and Care Research (NIHR) is supporting psilocybin research via the NIHR King’s Clinical Research Facility, the NIHR Oxford Health Clinical Research Facility, and the NIHR Maudsley Biomedical Research Centre, where researchers are developing and evaluating the efficacy and safety of psilocybin therapies.