GB-GOV-28-MHRA-GAMRIF Medicines and Healthcare products Regulatory Agency (MHRA) This project aims to establish the MHRA as a central source of regulatory scientific support for GAMRIF-funded innovations addressing antimicrobial resistance (AMR), with a focus on helping developers of novel products, including vaccines, diagnostics, bacteriophages, and microbiome-based therapies, navigate regulatory pathways and improve their chances of approval in both low- and middle-income countries (LMICs) and high-income countries (HICs). It is responding to a key challenge in the AMR landscape: many promising products are being developed by academic groups and SMEs with limited regulatory experience, while many LMICs face constraints in the regulatory capacity needed to assess these complex new technologies. To address this, MHRA is combining its regulatory expertise with its laboratory and standards capability at the NIBSC MHRA Science Campus, South Mimms to provide wraparound support across the GAMRIF portfolio. This includes early regulatory advice, regulatory science research to help define quality and evaluation frameworks, and support for the development of calibrants, controls, assays, and reference materials needed to assess critical product attributes. The project is also engaging directly with innovators through workshops and one-to-one discussions to identify common scientific and regulatory themes, understand product-specific development challenges, and shape a programme of support that reflects the needs of the portfolio. Alongside direct support to innovators, the project is developing wider tools that can strengthen regulatory readiness globally, including exploratory guidance, regulatory points to consider, and internationally recognised reference materials such as potential WHO International Standards. MHRA is also building collaborations with international regulators, WHO, and partners in LMICs to align regulatory thinking, reduce duplication in regulatory science research, and improve access to open, practical guidance. Overall, the project is embedding regulatory science into the AMR innovation pathway so that safe, effective, accessible, and affordable products are better positioned to reach the populations that need them most. Medicines and Healthcare products Regulatory Agency (MHRA) Department of Health and Social Care (DHSC) Clinton Health Access Initiative (CHAI) Phages for Global Health Due to delays in beginning recruitment the project start date was delayed five months. The MHRA received 100% of the allocated grant funds. 451965 387861 416994 247000 DHSC - GAMRIF (111416)- Regulatory science and policy support for Global AMR Innovation Fund -funded programmes -Funds received from DHSC via ALB budget transfer. 34464.90 34464.90 34464.90 35000 65000 DHSC - GAMRIF (111416)- Regulatory science and policy support for Global AMR Innovation Fund -funded programmes -Funds received from DHSC via ALB budget transfer for Q3 period FY25-26. 8202 32356.1