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 Lecheng" in Hainan Province. In 2020, the National Medical Products Administration (NMPA) issued a draft guideline on the "Use of real-world data to support clinical evaluation for medical devices", suggesting that RWE derived from RWD could support clinical evaluation throughout the life cycle of a medical device. Meanwhile, the Chinese government has allowed qualified RWD collected in Boao Lecheng to support registration application of innovative medical devices and drugs in China. These medical devices and drugs should have been approved abroad, but not in China yet, and met urgent and unmet medical needs in China. The article also presents the successful story of an innovative Glaucoma drainage tube as the first medical device approved in China using RWE generated in Boao Lecheng in 2020. Although we are witnessing an increased interest in RWE, a few challenges remain, e.g., limited data accessibility and data sharing, concerns on data quality, etc. Collaborations among relevant stakeholders in the RWE research are vital to address the challenges.

Keywords: China; Medical device; Real-world data; Real-world evidence; Regulatory decision.