The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report

Anna M.G. Pasmooij*, Peter G.M. Mol, Jacob Cornelis Bot, Hubert G.M. Leufkens

*Corresponding author for this work

    Research output: Contribution to journalReview articlepeer-review

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    Abstract

    In the Netherlands, drug regulatory science is a vibrant national and internationally oriented community. In this review, we present the factors that have contributed to this successful collaboration between relevant stakeholders and that led to a surge of activities around how regulatory science became embedded in the ecosystem of medicines research, clinical pharmacology, policymaking and regulation. We distinguished three pivotal episodes: (i) TI Pharma Escher-project, (ii) Dutch Medicines Evaluation Board as catalyst of the big jump, and (iii) Regulatory Science Network Netherlands and multistakeholder engagement. The research agenda has been influenced by the dynamic evolution of legal frameworks in Europe, such as the EU orphan medicines legislation of 2001 and the EU pharmacovigilance legislation of 2012. All these developments have inspired and have raised pertinent regulatory sciences questions. Furthermore, clinical pharmacology as a discipline has been very influential in shaping regulatory science, contributing to discussions on the level of clinical evidence that is necessary to justify marketing approval of a new medicine. With a growing interest of multiple parties such as academics, European Medicines Agency, national agencies, patient organizations and EFPIA, connecting regulatory science activities is key.

    Original languageEnglish
    Pages (from-to)64-71
    Number of pages8
    JournalClinical Pharmacology and Therapeutics
    Volume116
    Issue number1
    DOIs
    Publication statusPublished - Jul-2024

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