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Guidance on labelling for medicinal products used in clinical trials.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Guidance on the various types of modifications that can be made to a clinical trial approval.
How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Guidance on transitional arrangements for the Clinical Trials Regulations.
The review of the safety of isotretinoin has concluded.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Guidance on using non-investigational medicinal products in a clinical trial.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Guidance on clinical trials that are categorised as ‘notifiable’.
Guidance on the process for ending a clinical trial.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Clinical trial applications that need expert advice from a specialist group or committee.
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
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