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Helping interpret the Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 regulations.
Guidance to help medicine manufacturers meet safe limits on levels of nitrosamine impurities in medicines.
An overview of the legal requirements for children’s medicines that marketing authorisation holders (MAHs) need to abide by.
The MHRA’s AI Airlock pilot phase ran between April 2024 and March 2025. This report does not constitute formal MHRA guidance.
This report reviews data on patient doses and equipment trends in dental X-ray imaging procedures between 2014 and 2017.
Guidance for clinical trials that use Decentralised Manufactured Investigational Medicinal Products (IMPs).
Guidance for industry on flexible approaches we are taking on good distribution practices.
Information on how to request assistance from the NSDR.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Guidance for industry on flexible approaches to regulation we are taking during the COVID-19 outbreak.
Video series explaining the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Explainer for industry on the main changes introduced by the Windsor Framework on the supply of medicines in Northern Ireland.
Guidance on the updates to reporting forms following implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
How to best protect patients and volunteers during magnetic resonance imaging (MRI) examinations.
Background information for MHRA AI Airlock launched in Spring 2024 and is the MHRA’s first regulatory sandbox for AI as a Medical Device (AIaMD) products.
A practical guide to using medical devices in a range of healthcare settings.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
How investigators and sponsors should manage clinical trials during COVID-19
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