MHRA Innovation Office
The MHRA’s Innovation Office offers access to expert regulatory guidance for developers of innovative medicines and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulatory framework
Overview
The Innovation Office is part of the MHRA’s Innovation Accelerator which supports queries regarding innovative medicines, medical devices, and novel manufacturing processes that face regulatory challenges, uncertainties, or gaps in the current regulatory framework. This service is available to organisations of all backgrounds and sizes based nationally or internationally including academics, not for profit organisations, and patient groups involved in research and industry.
The Innovation Office offers access to free and confidential expert regulatory information, advice, and guidance.
Areas of Support
The Innovation Office welcomes queries from those developing:
- innovative medicines (see also the Regulatory Advice Service for Regenerative Medicines) including therapeutic blood derived products
- novel manufacturing processes for medicinal products
-
innovative medical devices which challenge existing regulatory frameworks*
- Note: General queries relating to medical devices, including software and AI as a medical device classification questions, should be directed to info@mhra.gov.uk
Queries are encouraged for products or technologies that challenge the existing regulatory framework, especially those in early development stages, in areas of regulatory uncertainty, or in fields experiencing rapid change. The office provides access to the MHRA’s world-class regulatory knowledge, expertise, and experience.
For further insight, case studies are available showing how the MHRA helped several companies to navigate regulatory processes for launching innovative new medicines and medical devices.
Get Advice and Support from MHRA The MHRA offers separate advisory services for:
- scientific advice for medicines
- regulatory advice for medical devices (including software and AI)
- clinical investigations advice for medical devices
To support innovators, the Innovation Office has outlined key guidance for medicines and medical devices based on common enquiries. You are encouraged to review this ahead of submitting an enquiry to the Innovation Office. Further information available is available here.
How to get in touch with the Innovation Office and what to expect
Queries for the Innovation Office can be sent by email to InnovationOffice@mhra.gov.uk
Please provide sufficient information to allow us to understand your product and the context for the questions you would like us to address. In the absence of relevant information, we may be unable to provide the response you require.
Your request will be triaged and assessed according to the information provided and your needs. The Innovation Office aims to respond within 20 working days.
The Innovation Office aims to supply you with advice and guidance to help you navigate the regulatory framework and understand the next steps in your development. Where relevant, the Innovation Office may signpost to other sources of information and support from the MHRA.
In some cases, an informal Innovation Surgery meeting (conducted remotely) may be proposed to discuss your query in greater detail. This service is provided free of charge.
Additional Contact details
Further information on how to submit general enquiries about a medicine, medical device, or software and AI as a medical device to the MHRA is available here.
For general enquiries contact info@mhra.gov.uk