Role of the group
The office has been set up to help companies, small and medium-sized enterprises (SMEs), academics and individuals who have developed a novel medicine or device, or a novel approach to the development or manufacture of a product, in their regulation. Examples of innovative products include Advanced Therapy Medicinal Products (ATMPs), nanotechnology, stratified medicines, novel drug/device combinations, and advanced manufacturing.
The Medicines and Healthcare Products Regulatory Agency (MHRA) doesn’t intend to publish the questions received by the Innovation Office and their answers to maintain confidentiality. However, if certain questions are submitted regularly, MHRA may issue general guidance on the topic. Anyone developing an innovative product or process can submit a query to the Innovation Office.
MHRA won’t release confidential information received via the Innovation Office into the public domain or discuss confidential information with other companies.
The MHRA Innovation Office was set up by MHRA as part of the UK government’s industrial strategy for life sciences. It covers novel medicines, medical devices and processes used to manufacture these products.
We would be particularly interested in discussing technology or products that could potentially challenge the current regulatory framework, due to their novel technology, materials used or as a result of convergence of technology, whereby a technology that is established in other fields is applied to medical devices for the first time.
Areas of technology that are a current focus include novel materials, regenerative medicine, nanotechnology, synthetic biology and software as a medical device.
MHRA hasn’t adopted a strict definition of innovative, but we envisage that the office will be used by companies, SMEs, academics and individuals who are developing a new technology used for the first time in the healthcare industry, a new material, or new type of product (examples include gene and cell therapy products, nanomedicines, new delivery systems, novel manufacturing processes, etc).
Regulatory queries on regenerative medicines
The MHRA Innovation Office is the first point of call for regulatory queries about regenerative medicines. It manages referrals to 4 regulators in the field:
- Human Tissue Authority (HTA)
- Human Fertilisation and Embryology Authority (HFEA)
- Health Research Authority (HRA)
- Medicines and Healthcare products Regulatory Agency (MHRA)
You can submit any query relating to the regulation of regenerative medicines, including ATMPs.
The term ‘regenerative medicine’ refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function. This includes cell therapies, tissue engineering, gene therapy and biomedical engineering techniques, as well as more traditional treatments involving pharmaceuticals, biologics and devices.
MHRA has helped companies move forward with innovative health plans by providing regulatory advice early on in the process.
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.
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 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.
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.
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.
If you’re a pharmaceutical researcher, developer or manufacturer and have a question about an innovative medicine, device or novel manufacturing process, contact us:
You will receive a response within 20 working days. Depending on the nature of the query, your response will consist of either a simple answer or a recommended course of action, which may involve regulatory or scientific advice.