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Points to consider when using real-world data in clinical studies
The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both.
This guidance sets out the warning statements which should appear on the label and/or in the leaflet of certain medicines.
Guidance for organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA, covering the approval of paper documents when working from home
Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
Guidance on the steps manufacturers and suppliers can take to ease supply shortages.
Information for patients, healthcare professionals and the wider public to help better understand the importance of AAIs as a potential life-saving medicine.
To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products.
Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living.
Guidance for GLP facilities on implementing and maintaining a risk-based quality assurance programme.
Apply for and maintain registrations for the brokering of human medicines.
The UK Good Laboratory Practice Monitoring Authority (UK GLPMA) recognises that there are potential challenges COVID-19 will present to members of the GLP monitoring programme.
Guidance on the procurement of in vitro diagnostic (IVD) medical devices, their safety, quality and performance.
How the supply of medical devices from Great Britain into Northern Ireland works.
Checklists providing a practical guide to using medical devices.
Find out which COVID-19 test products have been approved.
How traditional herbal medicines and homeopathic medicines will be treated by the MHRA.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Information about suspected side effects of e-cigarettes and how to report side effects.
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