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A Comprehensive Procedure to Evaluate the In Vivo Performance of Cancer Nanomedicines
07:59

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From complexity to approval in the European Union: Regulatory pathways and data challenges in the evaluation of

Gaёlle Andriantafika1, Heidi Janssen1, Ewa Balkowiec-Iskra2

  • 1European Medicines Agency, Amsterdam, the Netherlands.

Drug Discovery Today
|June 16, 2026
PubMed

Keywords:
European Medicines AgencyOrphan medicinesbenefit–risk assessmentconditional marketing authorisationmarketing authorisation under exceptional circumstancesrare diseasesregulatory pathways

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