Skip to main content
Medicines, medical devices

Guidance and regulation

Skip to results
399 results sorted by Most viewed
  • 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.