The platform technology approach in the EU regulation of medicines for human use: stakeholder perspectives on its definition and implementation

Drug Discovery Today 2026 Open access

Read full text
Authors: Stephanie M. P. Oskam, Lourens T. Bloem, Marcel H. N. Hoefnagel, Falk Ehmann, Mike Broeders, Anna M.G. Pasmooij
DOI: 10.1016/j.drudis.2026.104740
Cited by: 1
References: 20

Abstract

The upcoming revised European Union (EU) general pharmaceutical legislation will incorporate the concept of the platform technology approach. Based on focus group discussions, we provide perspectives on the definition and implementation of the platform technology approach. The definition should enable the use of this approach across the entire medicine lifecycle, and for all types of medicines and disease areas. Regulatory acceptability depends on the availability of robust, platform-specific data, while clinical acceptability requires clear communication to ensure trust. The successful implementation of the platform technology approach further depends on key factors, including stakeholder collaboration to establish a clear and effective EU regulatory framework.

Fields of Study & Subjects

Pharmaceutical Quality and Counterfeiting Technology Environment Urban Planning Pharmaceutical Economics and Policy

Publication details

Journal / source
Drug Discovery Today
Publisher
Elsevier BV
Volume
31
Issue
5
Pages
104740–104740
Publication date
17 July 2026
Language
EN