In April 2024, the Global Antimicrobial Resistance Innovation Fund (GAMRIF) awarded £1.8M to the MHRA for a three-year programme of work that will derisk and complement investments in its portfolios, including CARB-X, GARDP, BactiVac, IDRC, FAILSAFE, and C-CAMP.
GAMRIF supports early-stage innovative research in underfunded areas of antimicrobial resistance (AMR) such as therapeutics, vaccines and diagnostics across One Health for the benefit of people in low- and middle-income countries (LMICs).
As well as directly funding research and development of innovative AMR solutions, GAMRIF works with research organisations, governments, and industry around the world to:
The MHRA-GAMRIF team forms part of the wraparound support offered to innovators in GAMRIF-funded programmes. We work with innovators and other GAMRIF partners and stakeholders to identify barriers and challenges that could delay market approval and help to develop and implement solutions.
Our approach has included mapping the AMR innovation landscape to identify where regulatory science, knowledge sharing, and education can bring clarity about regulation to product developers. The development reference materials forms a large part of the team’s activities, for use in validating methodologies used to assure product quality, safety, and efficacy as part of their market authorisation applications. The MHRA-GAMRIF team also look to work with fellow regulators as well as publicly funded bodies and non-profit organisations to drive the timely delivery of safe and effective solutions that tackle the global AMR crisis.
We are a team of three scientists; Dr. Carmen Coxon (Principal Scientist) leads the team, with a background in haemostasis and drug discovery, Dr. Leanne Cleaver (Senior Scientist) with a background in clinical microbiology, and Dr. Matthew Lamaudière (Senior Scientist) with a background in molecular microbiology.
26 - 27 March 2025The two-day meeting brought together stakeholders from across the product lifecycles of therapeutics, diagnostics, and vaccines with a One Health and LMIC focus. During the meeting, innovators heard from experts across seven different workshop themes: ideation, preclinical, clinical, manufacturing, regulation, registration, and access and adoption. Challenges faced by product developers were identified, deconstructed and discussed, as well as their potential solutions. A meeting report is in preparation for publication.
Phages for Global Health, headed by Dr. Tobi Nagel, is a non-profit organisation established to
help “bring phage expertise to the developing world”, across LMICs to build expertise and
capacity for One Health phage applications including development and maintenance of phage banks as well as regulatory systems surrounding the use of phage products.
GAMRIF, through the MHRA-GAMRIF team, funded workshops in Malaysia and Uganda focused on tackling some of the wider healthcare system and regulatory challenges (March 2025).
Based on discussions with product developers working on non-traditional antimicrobial therapeutics, we recognised that there was a need to address questions developers had about the route of products to the UK market. On the 11th of November 2025 we convened a workshop with representatives from the developer community as well as defence, veterinary, and healthcare technology assessment bodies to discuss these questions. We are looking to develop the meeting outcomes into a publication to share learnings.
A number of therapeutics in the GAMRIF portfolio are targeted at biofilm infections, including small molecules and biologics. The MHRA-GAMRIF team have attended and presented at workshops organised by the National Biofilm Innovation Centre (NBIC), both national and international, to understand the regulatory science needs of anti-biofilm product developers. We are starting the process of developing a physical reference material to harmonise biofilm research and product development. Collaboration on any aspect of biofilm research is welcomed, and we urge you to get in touch with Biofilms@mhra.gov.uk if interested.
In collaboration with the Microbiology Society Knocking Out AMR programme we are running a new series of webinars for GAMRIF-funded product developers and stakeholders and Microbiology Society members to provide insight and real-world examples from experienced members of the community. This will enable people to share lessons learned and exchange knowledge to counter the loss of AMR professionals from the community.
As part of our efforts to provide clarity around the regulation of novel products in the AMR space, and awareness of the challenges of those working to develop bacteriophage therapeutic products, the MHRA published “Regulatory considerations for therapeutic use of bacteriophages in the UK”. Released, 4th June 2025.
This document consolidates information for both licensed and unlicensed routes, covering stages from preclinical development to post-licensure pharmacovigilance. Its aim is to help developers navigate regulatory frameworks and support product development for patient benefit.
Following recommendations from the House of Commons Science, Technology and Innovation Committee bacteriophage inquiry, we published a companion scientific paper, written in collaboration with the Innovate UK Phage Innovation Network, to aid developers interpret the regulatory publication, entitled “Interpretation guidance for MHRA regulatory considerations for phage therapeutic products”.
Most recently, we contributed to ‘Considerations and perspectives on phage therapy from the transatlantic taskforce on antimicrobial resistance’ alongside other TATFAR members to provide a review of phage regulation across TATFAR member states.
We understand that it is important for innovators to not only find relevant information, but also to be able to understand it.
Multi-Agency Regulatory Groundwork for Engineered Phage Regulatory SandboxThe group secured funding from the UK’s Department of Science, Innovation and Technology (DSIT) Engineering Biology Sandbox Fund (EBSF) to work on regulation pertaining to engineered and synthetic bacteriophages. See here to view the project overview.
The grant will fund four posts over two years across the MHRA, UK Health Security Agency (UKHSA), Food Standards Agency (FSA), Veterinary Medicines Directorate (VMD), and Department for Environment, Food and Rural Affairs (Defra).
If you would like to engage with or have any questions regarding this work, please email PhageSandbox@mhra.gov.uk.
In collaboration with the Clinton Health Access Initiative (CHAI) the MHRA, through Garrett Ehinger, are undertaking an exercise to map regulatory landscapes across different geographic regions (e.g., Association of South East Asian Network states and Africa). Our aim is to develop an accessible tool to help product developers understand the regulatory requirements of the countries they are seeking market approval in. We hope that this tool will help lower the barrier to taking products to where they are most needed.