Related Experiment Video
Updated: Aug 6, 2026

Digital Home-Monitoring of Patients after Kidney Transplantation: The MACCS Platform
Published on: April 12, 2021
The platform technology approach in the EU regulation of medicines for human use: stakeholder perspectives on its
Stephanie M P Oskam1, Lourens T Bloem2, Marcel H N Hoefnagel3
1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; Dutch Medicines Evaluation Board, Utrecht, the Netherlands.
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.
Related Concept Videos
Drug Control Governance: Regulatory Bodies and Their Impact
Drug Regulation
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
Drug Products: Biologics, Biosimilars and Interchangeables
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Biopharmaceutical Factors Influencing Drug Product Design: Overview

