Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model

Philip A. Hines*, Richard H. Guy, Angela Brand, Anthony J. Humphreys, Marisa Papaluca-Amati

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Regulatory science underpins the objective evaluation of medicinal products. It is therefore imperative that regulatory science and expertise remain at the cutting edge so that innovations of ever-increasing complexity are translated safely and swiftly into effective, high-quality therapies. We undertook a comprehensive examination of the evolution of science and technology impacting on medicinal product evaluation over the next 5-10 years and this horizon-scanning activity was complemented by extensive stakeholder interviews, resulting in a number of significant recommendations. Highlighted in particular was the need for expertise and regulatory science research to fill knowledge gaps in both more fundamental, longer-term research, with respect to technological and product-specific challenges. A model is proposed to realise these objectives in Europe, comprising a synergistic relationship between the European Medicines Agency, the European Medicines Regulatory Network and academic research centres to establish a novel regulatory science and innovation platform.

Original languageEnglish
Pages (from-to)2530-2534
Number of pages5
JournalBritish Journal of Clinical Pharmacology
Issue number12
Early online date17 Oct 2019
Publication statusPublished - Dec 2020

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