The MHRA Innovation Office is open to ideas for innovative medicines, medical devices and manufacturing processes. It provides free and confidential expert regulatory information, advice and guidance to organisations of all backgrounds and sizes based nationally or internationally. Call our customer services team on 0203 080 6000.
Hear from healthcare innovators
How we can help
We provide access to world-class regulatory knowledge, expertise and experience from within the MHRA regulatory centre, as well as from the Clinical Practice Research Datalink (CPRD) and the National Institute for Biological Standards and Controls (NIBSC).
This approach helps to ensure that your query has been reviewed and answered by the most relevant experts in the field for healthcare products within the UK regulatory framework.
You can also access:
- Regulatory advice: information, advice and guidance that clarifies regulatory requirements and helps you to develop your innovation with confidence.
- Referral to the Scientific Advice service is available if you are unsure whether regulatory or scientific advice is most appropriate for your stage of development of your medical product or drug device combination. There is a charge for Scientific Advice.
- Regulatory Advice Service for Regenerative Medicine: consolidated information and guidance, reviewed by 4 independent and UK-based agencies, for queries about regenerative medicines.
Find out more about how we have helped support innovation; read our case studies
It’s never too early to talk to us about your innovation
If you have a question about getting your innovation regulation ready, complete our form now.
For general enquiries, call our customer services team on 0203 080 6000 or email firstname.lastname@example.org.
About your innovation
The MHRA Innovation Office is open to all innovative queries - particularly those that challenge the current regulatory framework.
We can provide regulatory advice if you are developing a medicine where new technology or materials are being used for the first time in the healthcare industry, or where products like gene, cell therapy, or nanomedicines are being developed.
Medical devices/in vitro diagnostics (IVDs)/independent software apps
We can provide expert regulatory advice about your innovative medical device. Perhaps your innovation is in the area of novel technology/materials used or where technology has been adopted from other fields and is being applied to medical devices for the first time. Independent software and apps with a medical purpose can qualify as medical devices or IVDs. We can help you if you have questions on the regulatory status or classification of novel or innovative software/apps.
We can also advise on novel manufacturing processes, including site and facility design.
Confidential and timely
Submit your query via our form and you will receive a single, consolidated, considered and confidential response within 20 working days (depending on the complexity of the query) with regulatory information, advice and guidance to help you plan your project. In some cases, when our experts consider the issues to be complex or requiring clarification, we may propose a regulatory advice meeting to discuss the details of your query in more depth.
The Regulatory Advice Service for Regenerative Medicines
Support for queries about regenerative medicine
The MHRA Innovation Office is home to the Regulatory Advice Service for Regenerative Medicines for queries relating to this field.
This advice service offers research and development professionals across academia, industry and the NHS (including clinicians) a single point of access to free, joined-up regulatory information, advice and guidance from:
- Health Research Authority (HRA)
- Human Fertilisation & Embryology Authority (HFEA)
- Human Tissue Authority (HTA)
- National Institute for Health and Care Excellence (NICE)
- specialists across the MHRA, CPRD and NIBSC