AI Article Synopsis
- In the Netherlands, a strong collaboration in drug regulatory science has emerged, influenced by key stakeholders in research, policy, and regulation.
- The review highlights three main episodes: the TI Pharma Escher-project, the Dutch Medicines Evaluation Board's impact, and the establishment of the Regulatory Science Network Netherlands, which fostered multistakeholder engagement.
- Factors like evolving European legal frameworks and the contributions of clinical pharmacology have shaped regulatory science, emphasizing the importance of robust clinical evidence for drug approval and enhancing connections among various parties involved.
Article 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.
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| http://dx.doi.org/10.1002/cpt.3275 | DOI Listing |
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