Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics as part of a programme led by the Department of Health and Social Care (DHSC) to support the international community in tackling the growing threat of antimicrobial resistance (AMR).
The funding for this team will come from DHSC’s Global AMR Innovation Fund (GAMRIF) as part of a wider package to address the growing threat of AMR, announced at a global meeting hosted recently by the Royal Society which brought together world leaders and experts on the issue.
This team will enable the UK to develop an in-depth knowledge of new technologies and build an AMR community with global regulators, particularly in low- and middle-income countries. Innovations supported by this new team of experts will facilitate advances in diagnostics and, as a regulator of new medical products and technology, MHRA will be able to expand the scope of its knowledge to keep pace with scientific advances.
Dame June Raine, Chief Executive of the MHRA, said: “I am delighted that the MHRA can support regulators and experts across the world to tackle the growing threat of antimicrobial resistance, which has emerged as one of the key health issues of our time. Our vision is that the MHRA establishes a one-stop shop of regulatory scientific activities that supports GAMRIF-funded projects and programmes globally, wherever these novel products seek regulatory approval. This wrap around regulatory support will maximise the likelihood that innovative products developed within GAMRIF funded portfolios of context-specific, accessible, and affordable novel products, secure regulatory approval in low- and middle-income countries.”
Utilising MHRA’s world-leading laboratories, innovators developing novel AMR-circumventing products will gain access to:
- Early-stage regulatory advice provided through MHRA’s existing Innovation Accelerator
- Underpinning regulatory science research to establish the scientific framework for assuring the quality of AMR-tackling products
- Advice on the preparation of calibrants and run controls required to assure the quality of innovative products and related diagnostics.
While GAMRIF continues to leverage investment in accelerating research into novel antibiotics, MHRA will engage with innovators in its funded portfolios to advise on the potential regulatory challenges that LMICs frequently encounter.