Opportunities for using Real-World Data to Generate Real-World Evidence in Japan
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.
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