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How to apply for a clinical trial from 28 April 2026, including eligibility, documentation and registration in a public registry.
Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Information about the reproductive risks of taking valproate medicines and the measures in place to reduce potential harm.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
How to use the procedure for medicines licensing applications.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance on the process for ending a clinical trial.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Information relating to good clinical practice (GCP) inspections.
Guidance on transitional arrangements for the Clinical Trials Regulations.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
How to conform with the legal requirements for placing medical devices on the market.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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