Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe

Wouter Boon, Ellen H.M. Moors, Albert Meijer, Huub Schellekens · 2010 · Clinical Pharmacology & Therapeutics

Summary. The European Union introduced conditional approvals and exceptional circumstances pathways to enable faster drug access while managing safety risks. This study found neither pathway accelerates overall approval timelines, though conditional approvals shorten clinical development. Exceptional circumstances approvals require less data but don't compromise drug safety. Both instruments successfully balance innovation speed with public safety demands.

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Boon, W., Moors, E. H., Meijer, A., & Schellekens, H.. (2010). Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe. Clinical Pharmacology & Therapeutics. https://doi.org/10.1038/clpt.2010.207

@article{boon-2010-conditional-approval-approval-under-exceptional,
  title   = {Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe},
  author  = {Wouter Boon and Ellen H.M. Moors and Albert Meijer and Huub Schellekens},
  journal = {Clinical Pharmacology & Therapeutics},
  year    = {2010},
  doi     = {10.1038/clpt.2010.207},
  url     = {https://doi.org/10.1038/clpt.2010.207}
}

TY  - JOUR
TI  - Conditional Approval and Approval Under Exceptional Circumstances as Regulatory Instruments for Stimulating Responsible Drug Innovation in Europe
AU  - Wouter Boon
AU  - Ellen H.M. Moors
AU  - Albert Meijer
AU  - Huub Schellekens
JO  - Clinical Pharmacology & Therapeutics
PY  - 2010
DO  - 10.1038/clpt.2010.207
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ER  -

Details

DOI: 10.1038/clpt.2010.207
Countries: European Union
Categories: policy, general-innovation
Added: 2026-04-28