GOV.UK
Medicines, medical devices and blood regulation and safety
Services
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Sunset clause: request for public health exemption
Apply for a public health exemption from the sunset clause.
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Blood establishment authorisation application form
Form to apply for a blood establishment authorisation and guidance on completing the form.
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Blood facility declaration form
Blood facility declaration form to be completed and returned to MHRA.
Guidance and regulation
- Good clinical practice for clinical trials
- Good manufacturing practice and good distribution practice
News and communications
- Xofigo▼ (radium-223-dichloride): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial
- Daclizumab beta (Zinbryta▼): risk of immune-mediated encephalitis – some cases several months after stopping treatment
- Nusinersen (Spinraza▼): reports of communicating hydrocephalus; discuss symptoms with patients and carers and investigate urgently
- Letters and drug alerts sent to healthcare professionals in August 2018
Research and statistics
- Medicines: licensing time-based performance measures
- Early access to medicines scheme applications: pending, refused, granted
- General Pharmaceutical Services 2007/08 - 2017/18
- Good clinical practice inspection metrics
- Pharmacovigilance inspection metrics, 2009 to present
Policy and engagement
- Innovation: Queen’s University Belfast
- Innovation: MHRA advises the Cell Therapy Catapult of regulatory requirements
Transparency
- Medicines and Healthcare products Regulatory Agency spending over £25,000: 2018 to 2019
- Medicines and Healthcare products Regulatory Agency spending over £25,000: 2017 to 2018
- Medicines and Healthcare products Regulatory Agency GPC spending over £500: 2018 - 2019
- Clinical trials for medicines: authorisation assessment performance
- Good clinical practice inspection metrics