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Comply with good pharmacovigilance practice and prepare for an inspection.
How to renew marketing authorisations for products granted through different routes and at different times.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
A list of herbal medicines currently holding a traditional herbal registration (THR) granted by the Medicines and Healthcare products Regulatory Agency (MHRA).
Guidance on clinical trials that are categorised as ‘notifiable’.
The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
Requirements for sponsor representatives using EHR (electronic health records) in clinical trials.
Expressions of interest are invited from AI-enabled medical device manufacturers and NHS provider organisations interested in participating in the London Region I MHRA Regulatory Sandbox.
How to register as a manufacturer, importer or distributor of active substances.
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Webinar recordings providing information about plans for implementing the new Clinical Trial Regulations.
How to change the ownership from one marketing authorisation (MA) holder to another.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Information about the MHRA's duties and how you can report a non-compliant medical device.
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