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.
Access your copy to discover the following
  • The MHLW has clarified its guidance on the use of registry data for regulatory approval of orphan drugs for rare diseases.
  • Issues impeding the use of RWE for regulatory approval in Japan include: 1) immaturity of medical databases, 2) limited access to patient data, 3) unlinked databases, and 4) lack of motivation to conduct observational studies due to the National Health Insurance (NHI) pricing system.
  • Committee members of the  Pharmaceutical Research and Manufacturers of America (PhRMA) have obtained limited access to the National Database (NDB) and continue to work on obtaining greater access.
  • The vision of the pharmaceutical industry in Japan is to follow worldwide trends and utilize the wealth of data being collected in the NDB to tailor treatments according to patient backgrounds.
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.
Download your whitepaper here
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Kana Chia
Head of Japan
Reuters Events
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