The evolution of drug regulatory sciences in the Netherlands: 15 years
of follow-up
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, policy making and regulation. We
distinguished three pivotal episodes: 1) TI Pharma Escher-project, 2)
Dutch Medicines Evaluation Board as catalyst of the big jump, 3)
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, EMA, national agencies, patient
organisations and EFPIA, connecting regulatory science activities is
key.