Regulatory Science as a means to respond to EU healthcare challenges and global market needs

Authors

  • Fergal Donnelly European Commission B1049 Brussels

DOI:

https://doi.org/10.21423/JRS-V04N04P021

Abstract

The current regulatory approval system for the placing of healthcare products at the disposition of patients is essentially a binary exercise (approval /disapproval) and is a costly, long and tortuous process. Regulations that primarily reflect patient concerns and that facilitate product entry to market are needed. The process requires a pooling of resources on an unprecedented scale from widely diering sectors, both within industry and outside of it. The needs exist to establish open transparent and intense dialogue between regulators and the regulated, to bring the fruits of innovation to patients at an aordable price and to expedite the innovation process.

https://doi.org/10.21423/jrs-v04n04p021 (DOI assigned 5/14/2019)

Author Biography

Fergal Donnelly, European Commission B1049 Brussels

Principal Scientific Officer DG Research & Innovation

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Published

2016-10-27

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Section

Policy Commentaries