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bodies, government organizations, industry and academia leaders, and patient groups have started discussions to develop draft guidance for integrating RWE with reimbursement and regulatory decisions [1][2].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.
References:
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10405531/
[2] https://www.sciencedirect.com/science/article/pii/S0149291822000170
[3] https://globalforum.diaglobal.org/issue/may-2023/rwd-rwe-in-2023-regulatory-policy-world-tour/
[4] https://globalforum.diaglobal.org/issue/june-2022/real-world-evidence-regulatory-landscape-in-asia-pacific-australia-china-japan-south-korea-and-taiwan/
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7272364/
Share this story...
Real World Evidence (RWE) 201 – France – CNIL Regulatory Sandbox: Digital Health
RWE 201 - France – CNIL Regulatory Sandbox: Digital Health The French Data Protection Agency (CNIL) has been actively supporting digital health technology innovators through its regulatory "sandbox." These [...]
Real World Evidence (RWE) 201 – France – CNIL Reference Methodologies: Facilitating Access to Real World Data
RWE 201 - France – CNIL Reference Methodologies: Facilitating Access to Real World Data The CNIL (Commission Nationale de l'Informatique et des Libertés) is the French [...]
Real World Evidence (RWE) 201 – France – Health Data Hub: Facilitating Access to Real World Data
RWE 201 - France – Health Data Hub: Facilitating Access to Real World Data The purpose of France's Health Data Hub (HDH) is to facilitate the [...]
Real World Evidence (RWE) 201 – Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making
RWE 201 - Canada – Health Canada’s position on the CADTH Guidance for Reporting RWE to Support Decision-making Health Canada released its position (May 2023) on [...]
Real World Evidence (RWE) 201 – Canada – Methods and Guidelines for Reporting Real World Evidence
RWE 201 - Canada – Methods and Guidelines for Reporting Real World Evidence Guidance for Reporting Real-World Evidence (RWE) [published May 2023] is a comprehensive document developed by the [...]
Real World Evidence (RWE) 201 – Health Canada’s 15 Key Elements for Protocol Development
RWE 201 - Health Canada's 15 Key Elements for Protocol Development Health Canada acknowledges that RWE can be particularly useful in areas where conducting controlled clinical trials is challenging [...]
