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Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How the MHRA processes variations to marketing authorisations.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
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 to use the procedure for medicines licensing applications.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Keep up to date with the latest information from the UK GLP monitoring authority.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Information about the MHRA graduate scheme which is currently closed for applications.
How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
You must get permission to export certain drugs and medicines.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Information about Clinical Trials Regulations outlining expanded enforcement provisions, offences, and compliance requirements for sponsors and investigators.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
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.
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