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Br J Clin Pharmacol. 2019 Oct;85(10):2442-2445. doi: 10.1111/bcp.14070. Epub 2019 Aug 5.

Future of the drug label: Perspectives from a multistakeholder dialogue.

Author information

1
Medicines Evaluation Board, Utrecht, Netherlands.
2
Pfizer Netherlands, Capelle aan den Ijssel, Netherlands.
3
Department of Geosciences, Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, Netherlands.
4
Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, Netherlands.
5
Lygature, Utrecht, Netherlands.

Abstract

Regulating drugs does not end when market access has been granted. Monitoring drugs over the life cycle has become state of the art, inherent to evolving legislation and societal need. Here, we explore how the drug label could move along in a changing playing-field and become a sustainable label for the future. A dialogue between academia, government, the pharmaceutical industry and patient/societal organizations was organized by the Regulatory Science Network Netherlands. This is their view.

KEYWORDS:

SmPC; label; regulatory authorities

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