Exploration of the application path of real-world evidence in the reform of China's pharmaceutical regulatory system: a case study of Hainan Boao Lecheng

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Author: XIE Wansheng ^1# CAI Lixian ^1# LUO Wenya ² TONG Yeqing ³ LIN Kai ¹ LI Zhongyang ¹ CHANG Limei ¹  ZHAO Tuo ^1, ⁴

Affiliation: 1. Hainan Provincial Center for Drug and Medical Device Evaluation, Haikou 570100, China 2. Department of Rehabilitation, Haikou Orthopedic and Diabetes Hospital, Haikou 570300, China 3. Institute of Infectious Disease Prevention and Control, Hubei Provincial Center for Disease Control and Prevention, Wuhan 430079, China 4. Online Training Department, Institute of Executive Development, National Medical Products Administration, Beijing 100081, China

Keywords: Real-world evidence Real-world data Medical regulatory system Regulatory science

DOI: 10.12173/j.issn.1005-0698.202508076

Reference: XIE Wansheng, CAI Lixian, LUO Wenya, TONG Yeqing, LIN Kai, LI Zhongyang, CHANG Limei, ZHAO Tuo. Exploration of the application path of real-world evidence in the reform of China's pharmaceutical regulatory system: a case study of Hainan Boao Lecheng[J]. Yaowu Liuxingbingxue Zazhi, 2026, 35(3): 346-354. DOI: 10.12173/j.issn.1005-0698.202508076.[Article in Chinese]  Copied

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Abstract

Real-world evidence (RWE) as an important element of modern medical regulation is gaining growing attention in the global medical field. By integrating real-world clinical data, RWE provides new approaches for evaluating the safety and effectiveness of medical products. As China's first medical special zone, Boao Lecheng Pilot Zone of International Medical Tourism is committed to exploring the specific application paths of RWE in promoting the reform of China's medical regulatory system and scientific regulatory decision-making, and has become a model of innovation in this field. This article will discuss in detail the policy framework, specific implementation cases and challenges faced by Boao Lecheng in the application of RWE, aiming to provide references for the reform of China's medical regulatory system, and to look forward to the broad prospects of RWE in supporting the development and review and approval decision-making of innovative medical products in the future. Through in-depth analysis of the Boao Lecheng case, this article hopes to provide useful experience and insights for other regions in the application of RWE.

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