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Information on comparator products used in studies supporting abridged marketing authorisation application.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Guidance on using non-investigational medicinal products in a clinical trial.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Keep up to date with the latest information from the UK GLP monitoring authority.
How to conform with the legal requirements for placing medical devices on the market.
How to use the procedure for medicines licensing applications.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on the process for ending a clinical trial.
Guidance on transitional arrangements for the Clinical Trials Regulations.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
How to join the phase I accreditation scheme.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Fees payable to the MHRA from 2025.
How the MHRA makes decisions on what is a medicinal product (borderline products).
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
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