MHRA Innovation Office: guidance and support
Published 26 January 2023
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This publication is available at https://www.gov.uk/government/publications/mhra-innovation-office-guidance-and-support/mhra-innovation-office-guidance-and-support
Medicines
Support in the development of a medicine
Routes to patient access
- Apply for a licence to market a medicine in the UK
- Project Orbis
- Access Consortium
- Apply for the early access to medicines scheme (EAMS)
Medical Devices including software
Medical devices
- Medicines, medical devices and blood regulation and safety
- Medical devices regulation and safety - detailed information
- Factsheet: medical devices overview
- Medical devices: software applications (apps)
Clinical trials
For general guidance
For medical device clinical trials
For first-in-human clinical trials
GXP compliance
MHRA inspectorate
- Helping us to help you - MHRA Inspectorate (blog.gov.uk
- Medicines manufacturing
- MHRA Inspectorate BLOG
Manufacturing and GMP enquiries
- Good manufacturing practice and good distribution practice
- Blood: authorisations and safety reporting
- Apply for manufacturer or wholesaler of medicines licences
- Information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates for GMP, GDP, MIA, WDA
- Eudralex Volume 4 – GMP guidelines
Borderlines
Unsure if your technology is a medicine or a medical device?
- Borderline products: how to tell if your product is a medicine
- Borderline products: how to tell if your product is a medical device and which risk class applies
- Borderlines between medical devices and medicinal products
Innovative medical products
The Innovation Office is open to queries relating to products or technologies that challenge the current regulatory framework, particularly those early in their development phase or in areas of regulatory uncertainty or fields undergoing rapid change.