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”

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 Lecheng” i...

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Detalles Bibliográficos
Autores principales: Li, Jiahe, Liu, Lichang, Cao, Haijun, Yang, Mei, Sun, Xin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9850538/
https://www.ncbi.nlm.nih.gov/pubmed/36653783
http://dx.doi.org/10.1186/s12962-022-00412-w

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9850538/
https://www.ncbi.nlm.nih.gov/pubmed/36653783
http://dx.doi.org/10.1186/s12962-022-00412-w

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