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Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Information on applying quality by design, risk‑based quality management, and proportionate oversight in UK clinical trials.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Information about the MHRA graduate scheme which is currently closed for applications.
This guidance summarises our approach to pharmacovigilance
Comply with good pharmacovigilance practice and prepare for an inspection.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Information about the MHRA's duties and how you can report a non-compliant medical device.
How to renew marketing authorisations for products granted through different routes and at different times.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
How to register as a manufacturer, importer or distributor of active substances.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
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