MHRA Innovation Office

MHRA Innovation Office provides a single point of access to expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes develop innovative medicines, medical devices or novel manufacturing processes.

About the MHRA Innovation Office

The MHRA Innovation Office was set up in 2012, in response to calls from academia, government and industry, as a single point of access to free and expert regulatory information, advice and guidance that helps organisations of all backgrounds and sizes, including SMEs and individuals to develop innovative medicines, medical devices or novel manufacturing processes.

This service helps to make regulatory information clear and accessible to those who are working on innovative projects, ensuring that the UK remains one of the best places in the world to develop life sciences projects, in order to protect health and improve lives, here and around the globe.

The office is also the home to The Regulatory Advice Service for Regenerative Medicine, which responds to queries specifically about regenerative medicines.

About your innovation

The MHRA Innovation Office is open to queries about innovation in medicines, medical devices and novel manufacturing processes - particularly those that challenge the current regulatory framework.

Medicines

If your query is about medicines, 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, then get in touch.

Medical devices

Queries about medical devices, perhaps in the areas 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, are also of interest.

Medical device/in vitro diagnostics (IVDs) - independent software/apps

Independent software and apps with a medical purpose can qualify as medical devices or IVDs. If you would like to raise a query on the regulatory status or classification of novel or innovative software /apps, then please get in touch.

Manufacturing processes

Proposal for novel manufacturing processes, including site and facility design can also be discussed with you - send us your details.

Why choose the MHRA Innovation Office?

The office provides access to world-class knowledge, expertise and experience from specialists across MHRA, CPRD (Clinical Practice Research Datalink) and NIBSC (National Institute for Biological Standards and Controls), helping to ensure that your query has been reviewed and answered by the most relevant experts in the field. You can also access:

  • UK and EU regulatory advice: information, advice and guidance that clarifies UK and EU regulatory requirements and helps you ensure you can confidently develop your innovation for either regulatory environment.

  • Scientific advice: referral to the Scientific Advice Service is available through the MHRA Innovation Office if you are unsure whether regulatory or scientific advice is most appropriate for your stage of development. The provision of scientific advice from MHRA carries a charge.

  • Regulatory Advice Service for Regenerative Medicine: specific information and guidance, reviewed by four independent and UK-based agencies, for queries about regenerative medicines.

Confidential and timely

After submitting your query, you will receive a single, consolidated, considered and confidential response. This response will contain regulatory information, advice and guidance, helping you to work to clear and predictable timelines. Responses are sent in email format. We aim to get in touch within 20 working days, depending on the complexity of the query and the availability of key experts and specialists. In some cases a regulatory advice meeting may be proposed by the MHRA Innovation Office to discuss the details of your query.

Support for queries about regenerative medicine

The MHRA Innovation Office is home to the Regulatory Advice Service for Regenerative Medicines which responds to queries about regenerative medicine.

The 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 the Health Research Authority (HRA), Human Fertilisation and Embryology Authority (HFEA), Human Tissue Authority (HTA), and MHRA (Medicines and Healthcare products Regulatory Agency). Where necessary, the advice service can also link up to other specialist bodies such as the Health & Safety Executive (HSE) and Department for Rural Affairs (Defra).

Enquirers receive a consolidated response about the regulation of their regenerative medicine from these four independent and expert UK-based agencies through the MHRA Innovation Office.

Read our case studies

Queen’s University Belfast

Transdermal administration has many potential advantages, including the ability to prolong delivery over several days, improved compliance relative to oral delivery and a reduced side effect profile. Queen’s University Belfast (QUB) has been developing novel hydrogel-forming microarray patches that are showing considerable promise as an effective and safe platform for transdermal drug delivery, as well as for minimally-invasive patient monitoring/diagnosis. This case study looks at how the MHRA Innovation Office helped QUB in preparing for the regulatory framework that will be the final step in bringing innovation to market.

MSD

Enabling speedier access to novel treatments for patients with serious illness is a priority for governments, regulatory agencies and pharmaceutical companies alike. This case study details MSD’s journey through MHRA’s early access to medicines scheme (EAMS), highlighting the challenges, the positive outcomes for over 500 patients and the lessons learned about how to further streamline EAMS.

AstraZeneca

MHRA provided AstraZeneca with regulatory advice that enabled them to push forward with plans to build a new facility to continue supplying vital cancer treatment. See the case study for more information.

OxSonics

OxSonics have been able to develop their plan to produce innovative ultrasound technology using ‘sono-sensitive particles’ with MHRA’s help to navigate the regulatory process early on. The new plans could enhance drug delivery in cancer patients. See the case study for more information.

Eisai

MHRA’s early and flexible input helped Eisai, a Japanese pharmaceutical company, build innovative features into their European headquarters, research and production site in Hatfield. See the case study for more information.

Jenner Institute, University of Oxford

MHRA helped the Jenner Institute at the University of Oxford overcome the scientific and regulatory challenges they faced when developing a vaccine for malaria that made innovative use of viral vectors using chimpanzee virus DNA. See the case study for more information.

BTG plc

Taking on the manufacture of medical products requires commitment, investment and careful planning. Read about the advice and guidance MHRA provided to BTG to help them develop their £4million facility. Find out more about how we acted as a sounding-board and discover how we helped them mitigate risk on this project. See the case study for more information.

FUJIFILM Diosynth Biotechnologies (Fujifilm)

Investing in new, innovative technologies carries significant risk. Learn about how we helped FUJIFILM Diosynth Biotechnologies to future-proof their manufacturing facility in Billingham, UK. Understand more about Fujifilm’s ambitious plans in this area in the case study and discover why mammalian cell culture technologies are so important to the future development of novel therapies.

The Cell Therapy Catapult

The advent of induced pluripotent stem cells (iPS) sees medicine go beyond its traditional boundaries. But de-risking therapies like iPS so that their full potential can benefit public health, means overcoming many challenges. Our 7th case study showcases how MHRA’s advice and guidance helped the Cell Therapy Catapult to overcome these challenges, meet the regulatory requirements facing the development of a stem cell bank for iPS and undertake clinical trials currently taking place in Japan. Read our case study.

Submit your query

Complete our Innovation Office enquiry form or send an email to innovationoffice@mhra.gov.uk.

You can also follow the discussion on Twitter #HealthInnovation