Medicines and Healthcare products Regulatory Agency

Services and information

Blood regulation and safety

• Medical devices: how to comply with the legal requirements in Great Britain
• MHRA fees
• Make a payment to MHRA
• Blood: authorisations and safety reporting
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Clinical trials and investigations

• Clinical trials for medicines: manage your authorisation, report safety issues
• Clinical trials for medicines: apply for authorisation in the UK
• Managing clinical trials during Coronavirus (COVID-19)
• Notify the MHRA about a clinical investigation for a medical device
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Conferences and events

• Conferences and events
• Request a MHRA speaker at an event or conference

Good practice, inspections and enforcement

• Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)
• Good manufacturing practice and good distribution practice
• Good clinical practice for clinical trials
• Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
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Herbal and homeopathic medicines

• MHRA fees
• Apply for a traditional herbal registration (THR)
• Make a payment to MHRA
• Herbal medicines granted a traditional herbal registration (THR)
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Licensing

• Medicines: reclassify your product

Manufacturing, wholesaling, importing and exporting medicines

• Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
• Good manufacturing practice and good distribution practice
• Medicines: reclassify your product
• Medicines that you cannot export from the UK or hoard
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Marketing authorisations, variations and licensing guidance

• MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79%
• First oral antiviral for COVID-19, Lagevrio (molnupiravir), approved by MHRA
• One-dose Janssen COVID-19 vaccine approved by the MHRA
• First monoclonal antibody treatment for COVID-19 approved for use in the UK
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Medical devices regulation and safety

• Alerts, recalls and safety information: drugs and medical devices
• Regulating medical devices in the UK
• Register medical devices to place on the market
• Consultation on the future regulation of medical devices in the United Kingdom
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Scientific research and development

• Innovative Licensing and Access Pathway (ILAP): New partner announcement
• Prime Minister kicks off major new science initiative at visit of MHRA’s National Institute for Biological Standards and Control

Vigilance, safety alerts and guidance

• Coronavirus (COVID-19) vaccines adverse reactions
• Alerts, recalls and safety information: drugs and medical devices
• Drug Safety Update
• Report of the Commission on Human Medicines Expert Working Group on COVID-19 vaccine safety surveillance
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