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].
References:
[1] https://pubmed.ncbi.nlm.nih.gov/32894792/
[2] https://ibmi.taiwan-healthcare.org/en/news_detail.php?REFDOCID=0qvwj80x7fj37zxv
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6509937/
Share this story...
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 - [...]
Real World Evidence (RWE) 201 – EU – EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation
RWE 201 - EU - EMA Big Data Steering Group Updates Its Workplan to Accelerate Transformation to Data-Driven Medicines Regulation Updated EMA Big Data Steering Group Workplan: [...]
Real World Evidence (RWE) 201 – Germany’s Draft Health Data Usage Act
RWE 201 - Germany's Draft Health Data Usage Act Draft Health Data Usage Act (GDNG): https://www.bundesgesundheitsministerium.de/service/gesetze-und-verordnungen/detail/gesundheitsdatennutzungsgesetz.html BfArM Health Research Data Center: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/Forschungsdatenzentrum/_node.html In June 2023, the [...]
RWE 201 | A Landscape Analysis of Regional RWE Frameworks – The European Health Data Space and DARWIN-EU
RWR CONTEXT The European Union (EU) is making significant strides in advancing healthcare through a series of interconnected initiatives. The EU4Health Program aims to bolster health systems, focusing on crisis preparedness and disease [...]
Poland – The Journey towards Real World Evidence and Digital Transformation
RWE 201 - Poland – The Journey towards Real World Evidence and Digital Transformation Real World Evidence (RWE) and Real World Data (RWD) initiatives in Poland are still in [...]
Latvia – Making Early Strides to Implement RWE and RWD Initiatives
RWE 201 - Latvia – Making Early Strides to Implement RWE and RWD Initiatives Latvia is actively working on initiatives to implement Real-World Evidence (RWE) and [...]