Promoting patient-centered drug development from a regulatory perspective
DONG Li-juan
SUN Li-hua
Abstract：The concept of patient-centered drug development is emerging.Effective patient engagement(PE)contributes to the realization of this concept and is essential for successful drug development.To provide guidance for the construction of the PE system for regulators,we sort out the formation process of the PE systems for the US FDA and the EMA in this article.Based on innovation systems and network theories,the structural models were proposed for both of PE system respectively and conduct a comparative analysis.The two share the same initiating factors;however,they differ in their logical starting points for constructing a PE system.Each has developed into a PE system with the same local structure but different overall structure,along with their own advantages.The measures to promote patient-centered drug development are different,and the US FDA that provides common patient knowledge as a public good is more efficient.China's drug regulatory authorities should build its own PE system,and accelerate the implementation of patient-centered drug development and supervision in China.
Keywords：casemedicines developmentpatient-centeredpatient involvementEU EMAUS FDA
Publication Date：2025-05-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 897-902 )