Masterarbeit

China's Regulatory Framework for Companion Diagnostics: A Focused Comparison of Key Aspects with the US and EU

Dr. Wenrui Liu (2025)

Summary

Language: English

Companion diagnostics lie at the heart of precision medicine, selecting patients most apt to benefit from specific therapies and flagging those prone to adverse reactions, thereby optimizing treatment outcomes and reducing unneeded care. China has emerged as a dynamic and rapidly growing market for precision medicine, driven by robust government support, technological advancements, and an expanding patient base. This thesis examined the regulatory framework for companion diagnostics in China, complemented by a focused comparative assessment with selected aspects of regulatory systems in the EU and the US, highlighting their respective CDx definitions, classification schemes, and primary regulatory challenges.

Pages: 72