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A future for regulatory science in the European Union: the European Medicines Agency’s strategy
After 3 years of co-design with stakeholders and EU regulatory partners, the European Medicines Agency’s Regulatory Science to 2025 strategy has been finalized. Here, we highlight the core recommendations that stakeholders deem most significant to advance evidence generation.
European Medicines Agency, Amsterdam, The Netherlands; United Nations University – Maastricht Economic and Social Research Institute on Innovation and Technology (UNU-MERIT), Maastricht, The Netherlands.
Agencies that regulate medicines need to respond to the accelerating pace of change in medicine development. This response must ensure that regulatory science and the expertise of the regulators maintain the high standard required. However, this is only a minimum; regulators should also foster the translation of innovation into patient-centred access to medicines. To achieve this, the European Medicines Agency (EMA) undertook an extensive period of outreach, analysis and consultation with its scientific committees, stakeholders and EU regulatory partners. Shaped by this input, the EMA has now finalized its 5-year strategy, an initial draft of which was published1 in 2019. Below, we present the recommendations expected to have the greatest impact on improving patient-centred evidence generation. These are drawn from the core recommendations that were prioritized using qualitative and quantitative analyses from the public consultation and discussed at a recent workshop (see Related links).
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Nature Reviews Drug Discovery19, 293-294 (2020)
doi: https://doi.org/10.1038/d41573-020-00032-0
Disclaimer
The views expressed in this article are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.
References
Hines P. A. et al. The European Medicines Agency’s goals for regulatory science to 2025. Nat. Rev. Drug Discov.18, 403–404 (2019).
Hines, P. A. et al. Regulatory Science and Innovation Programme for Europe (ReScIPE): a proposed model. Br. J. Clin. Pharmacol.https://doi.org/10.1111/bcp.14099 (2019).
