Medicines: clinical trials hub
Information on clinical trials for medicines, how to apply for authorisation in the UK, how to manage your authorisation, reporting safety issues and details about the MHRA phase I accreditation scheme.
Guidance - before 28 April 2026
Clinical Trials guidance that should be followed prior to 28 April 2026.
Guidance - from 28 April 2026
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 come into force on 28 April 2026.
Until this date, the guidance in this section is in draft and should only be used to support sponsors in preparing for the implementation of the new regulations. Please see Clinical trials for medicines: apply for authorisation in the UK and Clinical trials for medicines: manage your authorisation, report safety issues for the guidance that should be followed prior to 28 April 2026.
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Payments and fees
Payments for DSUR submissions by credit or debit cards can be made via our payment centre.
Webinar recordings
Updates to this page
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Added 'International Council for Harmonisation (ICH) E6R3 Annotations'
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Added the following guidance pages to the collection: - Declaration of Helsinki and Clinical Trial Regulations alignment - Clinical Trials Regulations enforcement provisions - Archiving and retention of clinical trial records
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Added 'Common issues identified during clinical trial applications' to the group 'Guidance - before 28 April 2026'.
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Added link to payment DSU Payment centre to Pay an fees section of the collection.
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Added new page to collection: Route B substantial modification pilot
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Links added for draft guidance, to support amendments that come into force 28 April 2026.
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First published.