RWE 201 – South Korea’s Pioneering Approach: Integrating Real-World Evidence in Healthcare and Drug Development

South Korea has several initiatives to support healthcare and drug development using real-world evidence (RWE). The country’s regulatory bodies, government organizations, industry and academia leaders, and patient groups have started discussions to develop draft guidance for integrating RWE with reimbursement and regulatory decisions [1][2].

The Ministry of Food and Drug Safety (MFDS) in South Korea has recently issued guidelines on the use of RWE in regulatory decision-making, with a focus on the use of real-world data (RWD) to support clinical trial design and post-market surveillance [3]. In June 2021, the MFDS published the Guideline for Medical Information Database Research, which focuses on utilizing RWE that analyzed RWD, such as national health insurance data and electronic medical records, for post-marketing safety studies [4].

Moreover, the Korea Comprehensive Plan for Drug Safety Management (2020-2024) anticipates that the MFDS will continue to build a local ecosystem to leverage innovative technology, including RWE, to support new drug development [4].

In addition to these initiatives, an increasing number of studies are using healthcare claims databases to generate RWE for the effectiveness and safety of clinical therapeutics in South Korea [5]. These databases provide a rich source of RWD, which can be used to generate RWE for potential risk and benefit assessments derived from sources other than randomized controlled trials (RCTs) [5].

In summary, South Korea is actively working on leveraging RWE to support healthcare and drug development, with a focus on integrating RWE into regulatory and reimbursement decisions, supporting clinical trial design, post-market surveillance, and safety studies.







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