Health-Holland

The Netherlands is a frontrunner in regulatory science and innovation. Regulatory science is a relatively new discipline aimed at the development and validation of new standards and tools for assessing both the efficacy and the risks of medicines. Regulatory science is crucial in the improvement of the regulatory efficiency and efficacy of medicines assessment. Pioneering bodies In close collaboration with Utrecht University, the Dutch Medicines Evaluation Board (MEB) - an independent national authority that regulates the quality, efficacy and safety of medicines - has been pioneering the field of regulatory science and leading research efforts within the European network of regulatory Regulatory science & innovation authorities. The relocation of the European Medicines Association to Amsterdam bolsters the work of the MEB and provides a significant opportunity for the Netherlands to further strengthen its position as a frontrunner in regulatory innovation in Europe. Networks & platforms The Netherlands benefits from a close-knit network regarding regulatory science and several Dutch initiatives focus on improving the regulatory system and facilitating regulatory innovation. A prime example is Escher; a platform that brings together a wide variety of stakeholders (industry, academia, government and NGOs). Escher’s purpose is to promote research and international debate in the field of policy and regulations relating to development, market authorization, reimbursement, and use of medicines and medical technology in order to create an efficient and effective regulatory system. Another key initiative is the Regulatory Science Network Netherlands (RSNN): a national platform for dialogue and knowledge-sharing. The RSNN comprises a network of regulatory science experts from industry, academia, governmental bodies and the broader regulatory science field. Its mission is to advance an efficient and effective regulatory system for medicines development, marketing authorisation, access, and appropriate use of medicines, by sharing and disseminating knowledge among all stakeholders and setting the agenda for further research. “In the Netherlands, regulatory authorities and scientists from both academia and commercial companies jointly search for further improvement of medicine regulations, leading to tailor-made and practical advice and proposals for the assessment of new therapies.” Joop van Gerven , Chairman at Central Committee on Research Involving Human Subjects (CCMO) 28

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