Medicines Healthcare Products Regulatory Agency
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The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first in human (FIH) trials.
The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.
Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.
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Apply for the phase I accreditation scheme
Send the completed phase I accreditation scheme compliance checklist to phase1accreditationscheme@mhra.gov.uk.
Principal investigator in first-in-human (FIH) trials
To act as a principal investigator in a FIH trial, you must meet the requirements stated in the scheme.
However, if you do not have all the post graduate qualifications, but have extensive experience in conducting FIH trials, you may apply for an exemption to the scheme requirement.
This exemption is independently reviewed by Faculty of Pharmaceutical Medicine, who advise MHRA GCP inspectorate of their recommendation.
Updates to this page
Last updated 31 October 2024 +show all updates
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Updated 'Request for acceptance as a phase I principal investigator for first in human trials' document.
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Updated List of accredited phase I units
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Added List of Accredited Units 24 October 2023
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Replaced List of Accredited Units July 2023 with updated version: List of Accredited Units_15 September 2023
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List of accredited phase I units updated (up to 10 July 2023)
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List of accredited phase I units PDF replaced with new version
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Updated 'List of accredited units-27 February 2023'
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Updated 'list of accredited units' as of 1 Feb 23
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Updated 'list of accredited phase I units'
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Administrative updates to branding, format and staff titles.
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Updated 'List of Accredited units'.
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Updated 'list of accredited Phase I units' PDF.