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

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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 pages6
JournalBritish Journal Of Clinical Pharmacology
Issue number2
Early online date19 Aug 2019
Publication statusPublished - 1 Dec 2020

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)


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