Regulatory density as a means to refine current regulatory approaches for increasingly complex medicines

Kevin Klein*, Pieter Stolk, Marie Louise De Bruin, Hubert Leufkens

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

The continuous scientific, societal, and technological advancements have shifted drug development toward increasingly complex and ever more targeted treatments. This creates new and unprecedented challenges for global regulatory systems. To address the increased risks and uncertainties of increasingly complex medicine, we advocate for a more tailored and flexible regulatory approach, which is explained here with the concept of ‘regulatory density’. In the context of this paper, ‘regulatory density’ describes the relative amount of obligatory standards, measures and procedures applied to certain medicinal products or product classes and the resources required to meet these requirements. Given that risk and uncertainty are dynamic variables that can change over time, with this paper, we want to stimulate (re)thinking of regulatory approaches for managing the challenges of future complex medicines.

Original languageEnglish
Pages (from-to)2221-2225
Number of pages5
JournalDrug Discovery Today
Volume26
Issue number10
DOIs
Publication statusPublished - Oct 2021

Bibliographical note

Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Keywords

  • Adaptive pathways
  • Advanced therapy medicinal products
  • Biologics
  • Complex medicines
  • Medicine regulation
  • Non-biological complex drugs
  • Regulatory density

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