Around the Globe
Shionogi & Co., Ltd.
Shionogi & Co., Ltd.
eal world data (RWD) has grown into one of the buzzwords in the healthcare industry in Japan. Although utilizing sales data for pharmaceutical medicines in market surveys is an established practice based on RWD, changing circumstances and use of RWD in pharmaceutical and medical device companies in Japan have raised more issues and attention in recent years. The second DIA Health Economics Outcomes Research (HEOR) Workshop in Japan explored the ideal future direction for transforming RWD into real world evidence (RWE) suitable for regulatory decisions in the healthcare industry.
Key Takeaways
- Glowing reviews of various applications for RWE offer hope, but unresolved issues remain. It is important to consider if the data are reliable enough to serve as evidence in a rationale for regulatory approval or disapproval of a future medical treatment.
- Growing purposes for utilizing RWD in Japan include non-clinical research and pharmacovigilance.
- Effective utilization of RWE is only half of the story; completing it will require continuous and collaborative discussion and actions by multifunctional stakeholders.
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Patient Registries and Databases
Challenges for Regulatory Use
In the closing panel discussion, Tomoko Ohsawa (Director, Office of Non-Clinical and Clinical Compliance) shared PMDA’s regulatory viewpoint on these and related topics. From the regulatory perspective, it is important to consider if RWD can be used as evidence supporting a rationale for future medical treatment: Were the data appropriately collected and managed with this regulatory intent?
PMDA remains open to discussing the practice and impact of RWE on regulatory review in Japan, Ohsawa explained, and recognizes that continuous and collaborative discussion by multifunctional stakeholders is necessary for its full utilization.