RWE 201 – Taiwan: Integrating Real-World Evidence for Drug Development and Policy Making


Taiwan has several real-world evidence (RWE) initiatives to support healthcare and drug development. Over the past decade, RWE has been integrated into Taiwan’s national pharmacovigilance system, primarily using nationwide claims databases. Other sources of real-world data, such as national registries and large electronic hospital databases, have also become available recently [1]. The Taiwan Food and Drug Administration (TFDA) has published guidelines on the review of real-world data (RWD) and RWE-based applications to support and supervise new developments in this area [2].

One of the key data sources for RWE in Taiwan is the National Health Insurance Research Database (NHIRD), which covers more than 99.6% of the Taiwanese population[6]. The Ministry of Health and Welfare (MOHW) has established a Health and Welfare Data Center (HWDC) that centralizes the NHIRD and about 70 other health-related databases for data management and analysis[3]. This database has been used for various real-world studies, generating evidence to support clinical decisions and healthcare policy-making [3].

In summary, Taiwan has made significant progress in integrating RWE into its healthcare and drug development landscape, with the NHIRD being a major resource for generating RWE. However, further efforts are needed to improve procedural and methodological practices and to link different sources of real-world data [1].





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