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Guidance on the process for ending a clinical trial.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
This guidance summarises our approach to pharmacovigilance
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
How to join the phase I accreditation scheme.
The Defence and Security Accelerator (DASA) is running a Market Exploration to explore research and technology development of relevance to the modelling of traumatic wounds and the monitoring of their progression.
Information about the MHRA's duties and how you can report a non-compliant medical device.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
How to register as a manufacturer, importer or distributor of active substances.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
Medicines and Healthcare product Regulatory Agency official Parental Leave policy and procedures.
A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
Information about the MHRA graduate scheme which is currently closed for applications.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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