MHRA Innovation Office

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

The MHRA Innovation Office video

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 info@mhra.gov.uk.

About your innovation

The MHRA Innovation Office is open to all innovative queries - particularly those that challenge the current regulatory framework.

Medicines

We can provide 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 have experts available to discuss 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.

Manufacturing processes

We are also happy to discuss proposals for novel manufacturing processes, including site and facility design.

If you have questions about getting your innovation regulation ready, then complete our form or call our customer services team on 0203 080 6000 or email info@mhra.gov.uk.

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, 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:

Where necessary, the advice service can also link to other specialist bodies such as the Health & Safety Executive (HSE) and Department for Environment, Food & Rural Affairs (Defra).

Contact details

info@mhra.gov.uk