Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in “Boao Lecheng Pilot Zone”

Use of real-world evidence to support regulatory decisions on medical devices in China and a unique opportunity to gain accelerated approval in “Boao Lecheng Pilot Zone”

Abstract This article aims to summarize the development and challenges of real-world data (RWD) and real-world evidence (RWE) in China and introduce a unique opportunity for medical devices to gain accelerated regulatory approval in China by utilizing RWE generated in a free trade pilot zone “Boao L...

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Bibliographic Details
Main Authors: Jiahe Li, Lichang Liu, Haijun Cao, Mei Yang, Xin Sun
Format: Article
Language:English
Published: BMC 2023-01-01
Series:Cost Effectiveness and Resource Allocation
Subjects:
Real-world evidence
Real-world data
Medical device
China
Regulatory decision
Online Access:https://doi.org/10.1186/s12962-022-00412-w

Internet

https://doi.org/10.1186/s12962-022-00412-w

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