Abstract
The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its Regulatory Science Strategy to 2025 and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.
Highlights
The pace of innovation has accelerated, at the same time as medicines become more complex
The survey was designed by means of (a) discussions within EMA to identify what information we want from stakeholders and the phrasing of the respective questions, (b) alignment of these questions with the overarching goals of the RSS, and (c) trialing the survey with colleagues for further refinement
The qualitative and quantitative analysis for all the survey questions indicate that participants recognized the relevance of the regulatory science areas and the recommendations proposed in EMA’s strategy
Summary
The pace of innovation has accelerated, at the same time as medicines become more complex. This innovation is occurring across the entire medicine lifecycle, from candidate screening and characterization to pharmacovigilance and repurposing medicine. A comprehensive strategy including scientific, regulatory, operational, and resourcing is required to regulate the growing ecosystem of innovation in the development of human and veterinary medicines. This strategic response must leverage and advance collaborative approaches to evolve evidence generation and medicines development, such as new methods to replace, reduce and refine animal models; systematic patient engagement; use of digital and real-world data in clinical settings for pre and post authorisation benefit-risk. In the European context, this collaborative approach can be coupled with a greater integration with downstream decision makers, such as health technology assessment (HTA) bodies and payers, to expedite patient-centered access to innovative human medicine
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