Presentation (CTI)

OBJECTIVES: In the Asia-Pacific (APAC) region, regulators are increasingly integrating real-world data (RWD) into post-marketing surveillance (PMS); however the extent and impact of RWD use in APAC’s post-approval safety monitoring remain limited. This study aims to examine the extent of RWD integration into PMS in APAC (2020-2025), focusing on trends, methodological approaches, and the outcomes assessed (safety vs effectiveness) in studies using RWD for PMS.
METHODS: A PubMed literature search (2020-2025) was conducted to identify real-world evidence studies conducted for PMS of medical technologies across APAC. Eligible articles were defined as those evaluating regulatory-mandated or voluntary PMS using RWD in APAC. We extracted study characteristics (e.g., country, data source, outcomes) and conducted descriptive analyses to evaluate temporal and methodological trends.
RESULTS: Among 1,318 articles screened, 604 (46%) were included, of which 442 addressed regulatory-mandated or voluntary PMS for post-approval safety monitoring. The volume of APAC studies using RWD for PMS increased by 98% from 2020 to 2025 (58 to 115 studies per year), indicating accelerating interest in RWD for post-approval safety. Japan contributed two-thirds (67%) of these studies, far outpacing South Korea (16%) and China (9%). Most studies were prospective (76%, typically using electronic data capture systems), with fewer retrospective analyses (22%, often leveraging surveillance databases). Nearly all studies focused on pharmaceuticals (94%, mainly oncology) rather than medical devices (6%), and the majority assessed safety outcomes (96%) while 74% also evaluated effectiveness.
CONCLUSIONS: RWD use for PMS in APAC is increasing, but evidence remains concentrated in Japan and largely limited to prospective pharmaceutical safety studies. Addressing this imbalance by expanding geographic coverage, diversifying study designs, and incorporating non-drug technologies such as medical devices and digital health will be critical to strengthen RWD-informed regulatory decision-making across APAC.