Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey

Abstract

Background The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. Methods A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. Results Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development. Conclusions The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce.

Translating Academic Drug Discovery Into Clinical Development: A Survey of the Awareness of Regulatory Support and Requirements Among Stakeholders in Europe

“…11 Importantly, documentation and guidelines provided by the regulatory authorities need to be regularly updated to keep pace with emerging technologies and new methods of assessment. 12 Generally, EMA services were less known among academics than NCA services. Among other factors, this can be attributed to the fact that NCAs handle the CTAs that are needed to start a clinical study.…”

“…It helps academic researchers prepare and submit regulatory applications to the FDA, develop and write clinical protocols, and keep pace with changing federal regulations 11 . Importantly, documentation and guidelines provided by the regulatory authorities need to be regularly updated to keep pace with emerging technologies and new methods of assessment 12 …”

“… 11 Importantly, documentation and guidelines provided by the regulatory authorities need to be regularly updated to keep pace with emerging technologies and new methods of assessment. 12 …”

Opportunities and Risks of UK Medical Device Reform

“…For our participants, this opportunity was recognized, but even higher priorities for international engagement were avoiding import/export friction through alignment (or mutual recognition), adoption of international technical specifications wherever possible, and ensuring that patient safety was not compromised through lower standards; leadership was considered desirable particularly in those areas where no existing models were considered adequate (such as AIaMD). Nationally, close collaboration from different sectors of the system and stakeholder groups can build synergy and accelerate the future of innovation in the UK [ 21 ]. This effort, coupled with global partnership and leadership has the potential to better understand which markets or innovation spaces are most vital and helpful to the UK, and ultimately pursue the goal of developing a robust regulatory regime for medical devices that prioritizes patient safety.…”

Big data and predictive analytics in healthcare in Bangladesh: regulatory challenges

“…Rivera et al. suggested that regulator should employ regulatory science while developing a new policy framework concerning emerging technologies in the medical field ( Cruz Rivera et al., 2021 ). Regulatory science in healthcare can be defined as “the application of biological, medical and sociological sciences to enhance the development of medicines and devices in order to meet the appropriate standards, quality, safety, and efficacy” ( Calvert et al., 2021 ).…”