Real World Evidence (RWE) 201 – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation
RWE 201 – China’s Emerging Trend: Embracing Real-World Evidence in Drug Development and Regulation
– Zhong et al., Advancing the Development of Real-World Data for Healthcare Research in – – – China: https://bmjopen.bmj.com/content/12/7/e063139
– NMPA Guidelines on the Use of RWE to Support Drug Development: https://redica.com/wp-content/uploads/NMPA_-Attachment_-_Guiding-Principles-of-Real-World-Data-Used-to-Generate-Real-World-Evidence-Trial_.pdf
– Hainan Boao Lecheng International Medical Tourism Pilot Zone: https://www.cde.org.cn/main/news/viewInfoCommon/e3cd052e638876697399de962b7354a4
China is increasingly embracing the use of real-world evidence (RWE) in research and drug development. The systematic use of RWE to support drug regulatory decision-making is still in its infancy in China, but national drug regulatory authorities have begun applying RWE in the review and approval process. The application and development of real-world data (RWD) and RWE in drug regulatory decision-making have been vigorously promoted in China.
One of the ways China is using RWE is to support decisions about whether a drug should be included in the reimbursement list and whether it should be renewed. The Hainan Boao Lecheng international medical tourism pilot zone, known as the Hainan model, has been used to generate RWE to support regulatory approval without conducting a trial in China. This type of evidence could also be used to support reimbursement decisions to minimize delay to market entry.
However, there are challenges to the wider adoption of RWE in China. These include limited research capacity and the need for more researchers with in-depth understanding of methodologies, data, and healthcare settings in China. There are also regulatory hurdles, such as the need for approval from the Human Genetic Resource Administration of China (HGRAC) for studies using healthcare RWD, and cross border data transfer security assessments and licences.
Despite these challenges, there are signs of progress. For example, the province of Hainan has pioneered the use of RWE, including for drugs and medical devices that are new to China. The National Medical Products Administration (NMPA) of China has also published guidelines on the use of RWE in supporting drug review, indication expansion, post-approval evaluation, and research and development of traditional Chinese medicine.
In conclusion, while the use of RWE in China is still developing, it is gaining recognition and is being increasingly used in drug development research and regulatory decision-making. This trend is likely to continue as China seeks to improve its healthcare system and drug development processes.
