Opportunities for using Real-World Data (RWD) to Generate Real-World Evidence (RWE) in Japan
Real-world data (RWD) held in databases in electronic patient records, medical claims data, and disease registries could generate valuable real-world evidence (RWE) that could offer new insights into diseases, treatments, and new indications for drugs on the market.
Japan is finally, if cautiously, moving toward the exciting future. In March 2021, the Ministry of Health, Labour and Welfare (MHLW) in Japan, issued two guidance documents on “Points to Consider for Ensuring the Reliability in Utilization of Registry Data for Applications” and “Basic Principles on Utilization of Registry for Applications.”
This whitepaper clarifies the implications of this guidance and the challenges ahead.
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The Medical Affairs Committee and Communication Committee of PhRMA proposes to link medical records to national identification numbers (My Number), educate the public on the usefulness of linking the data, and ensure the safe handling of personal information. This could be a useful template for Japan to consider.