Horizon Scanning Case Study: What is an Actionable Horizon Scanning Signal (AHSS)?
Horizon Scanning in the MHRA Innovation Accelerator includes a focus on the identification of Actionable Horizon Scanning Signals, but what are these, and how and why do we identify them?
Background
Horizon scanning in the MHRA is supported and delivered by the Innovation Accelerator, the agency’s recently launched hub for supporting innovation. Horizon scanning aims to future-proof the agency by identifying emerging opportunities and challenges, to ensure we remain an enabling regulator capable of supporting safe innovation with respect to healthcare products - medicines, medical devices (including software) and blood components for transfusion in the UK. Horizon scanning helps to make us better at what we do in protecting public health and enables us to be aware of, and to prepare for, future technological and/or methodological advances.
Methodology
Horizon scanning in the Innovation Accelerator involves two parallel approaches: signals identified via systematic searches of publicly available sources such as academic papers, funding body news and other media sources, and also the submission of signals from MHRA colleagues in a variety of roles and fields. In addition, horizon scanning signals from stakeholders from outside the agency are welcome: if you have any suggestions, please email innovation.accelerator@mhra.gov.uk.
Scope
Alongside tracking trends and themes, we are particularly interested in signals that challenge current regulatory practices/frameworks or that identify opportunities to support the safe and timely development of new innovative products, so we can help identify solutions (e.g. the need for standards/expertise/guidance etc. in an evolving area).
Through a cross agency horizon scanning working group, signals are logged, characterised, filtered and prioritised based on their potential impact and if they fulfil the definition of an Actionable Horizon Scanning Signal (AHSS). An AHSS can be defined as a signal that result in us identifying a need to change what we do, how we do it, who is involved or expanding what we know.
Outcomes
The identification of AHSS can result in a number of different outcomes, from developing new or updating existing guiding principles/guidelines/guidance documents (see Horizon Scanning Case Study on Guiding principles that can inform the development of Good Machine Learning Practice), to legislative changes (see Horizon Scanning Case Study on Point of Care Manufacturing), to the establishment of new research or standardisation projects (see Horizon Scanning Case Study on Developing standards for Adeno-associated virus gene therapies) or the formation of internal interest groups, or workshops and training being planned on particular topics.
Jenny Buckland, Head of Horizon Scanning and Strategy, The Medicines and Healthcare product Regulatory Agency:
It’s not enough for horizon scanning intel just to be interesting, in the fast paced world of medical product development it has to have an impact on what we do, so we remain a forward thinking pragmatic regulator capable of supporting timely safe innovation for patients.